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Phase 1 July 2015

CM&S Library Infrastructure: Site Concept Users and Roles

This  project  will  create  a  digital  library  for  computer  modeling  and  simula8on  that  is  focused  on  sharing  quality  materials.  Phase  1  is  released  to  MDIC  project  teams,  and  phase  2  is  public  release.  Data  in  the  library  will  be  curated  and  stored  in  8ers.  These  collec8ons  of  data  can  be  rated,  reviewed,  searched  and  easily  downloaded.  Groups  can  collaborate  and  communicate  privately  while  comple8ng  MDIC  projects  and  publish  deliverables  publicly.  

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About the Library

• The one place users can come to find and share relevant information that they know is trustworthy.

• A place for the community to develop and curate content: − Tier 0 group members have a project space for developing works in

progress. − Tier 1 a public space to share content with the community for

feedback. − Tier 2 a managed space for peer review and publication of content. − Tier 3 the space for regulatory content.

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Library Infrastructure Timeline •  FDA Library Concepts & Knowledge Transfer October 2014 −  http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM358859.pdf −  http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM358855.pdf −  http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm346375.htm

•  Phase 0: Prototype large file upload/download/access; March 2015

•  MDIC Board of Directors approval for Phase 1 funding May 2015

•  Phase 1: Be the one place all MDIC CM&S work is archived, models and data shared •  This is for the working groups, not yet public August 2015

•  MDIC Board of Directors meeting and library report out September 24th, 2015

•  Phase 2: Store and curate regulatory grade models and data TBD Based on Resources

•  Public Deployment: Sustainable model for funds and resources TBD Based on Resources

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Project plan and updates

• See Power of Us Hub − https://powerofus.force.com

• See included pdf documents − 07.21.2015 MDIC library volunteer work packages − 07.21.2015 MDIC library infrastructure project plan and weekly update − 07.21.2015 library one page description − 07.21.2015 Requirements MDIC Library - User Stories

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Library for models, inputs, validation data:

Tier 1 Content from Authorized Group Members

General knowledge, links to other repositories, content seeking public feedback

Tier 3 Regulatory-grade Models and Data

FDA MDDT, MDIC accredited content,

Other FDA qualified content

Tier 2 Peer-reviewed Content

Models, data, periodicals, etc

Library Admin - FDA qualified or MDIC panel accredited against published standards

MDIC Journal with Editor and AEs, Reviewers from Group Members and Academics

Manager Approved Members and Tier 0 Members

Increase Evaluation Confidence

Faster Market Clearance

Decrease Cost

Tier 0 Group Projects

Collaborative content in progress Group Members

Phase 0: Prototype large file upload/download/access; Phase 1: Be the one place all MDIC CM&S work is archived, models and data shared; Phase 2: Store and curate regulatory grade models and data

Who Controls Submissions to each Tier:

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Metadata for Searching and Browsing the Library

•  Metadata is structured information that describes or makes it easier to retrieve or manage an information resource. −  Metadata is often called information about

information. −  Each entry to the library is a collection of files,

and the metadata describes the collection. −  Submissions are uploaded with attached

metadata. −  This metadata is the content that is searched,

this helps return relevant files after searching the library, and keeps files accessible.

•  Collection are the files uploaded by the submitter. −  Files are not searchable. −  Files can be of any type or size. −  The collection may include image thumbnail

files for preview. −  In Tier 2, the collection must include one pdf

for review that describes the submission.

More about the metadata in this library

Metadata

Name Description Keyword

Size Format

File 1

File 2

…

File n

Collection

Stored In Salesforce

Stored In Amazon

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Metadata

Metadata Fields Example How data is entered Name FDA Phantom Lung Nodule CT Image Database Keywords CT, computed tomography, lung, phantom, imaging Description A series of CT images acquired of an anthropomorphic lung phantom with inserted

nodules. Nodules vary in size, shape and location with known volume. The database consists of 634,256 images acquired on two commercial CT imaging systems

3500 char text box

Type Image data Device Area CT imaging devices, computer-aided diagnosis devices Source Image data acquired from phantom using commercial CT scanners Creator Marios Gavrielides Contributor Relation Database is still increasing with pending scans in 2014 Coverage 2007-2013 Format DICOM Picklist Size ~400Gb picklist with range buckets. Location https://wiki.cancerimagingarchive.net/display/Public/Phantom+FDA Hyperlink to an alternate location where

the data is located if not in the saleforce/S3 location. This could be a rich field or just a textbox. The former allows a hyperlink.

Acquisition Date 2007-2013 Created and last modified date from SF

Expected User Level Users familiar with the DICOM image format and have a basic understanding of CT imaging system parameters

Context of Use The development and testing of lung nodule size estimation software and related computer-aided diagnosis algorithms

State of Validation N/A (This is imaging data without associated claims of performance) Limitations Quality or Condition This is the result of a systematic approach to probe the most significant

imaging parameters and nodule characteristics affecting volumetric CT. The database has been utilized in several published studies and public algorithm challenges.

References Marios A Gavrielides , et al , “A resource for the assessment of lung nodule size estimation methods: database of thoracic CT scans of an anthropomorphic phantom”, Optics Express, vol. 18, n.14, pp. 15244-15255, 2010.

Text box, may also upload a reference list as a file but only the text box is searchable

Notes

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Software Development Process

•  The digital library begins with software infrastructure that is planned and managed. •  We are using an iterative software development process −  We can adapt to changes in the project along the way. −  We can focus on the most important things first −  We might not build the “right” thing the first time, but we can fix it as we go.

•  We will be building our requirements through user stories, this uses plain language, to explain real needs of the users.

•  User stories may follow this format: −  As a <type of user>, I want <some goal> so that <some reason>.

•  This is our first opportunity to request your feedback, please let us know about the mockup and user stories. What did we miss? What is most important? −  We will use your feedback to improve the user stories, and update requirements. −  The functional prototype is expected in August, we invite you to help us test the software.

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User Roles

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User Roles

User

•  User

Submitter

•  Submitter

Collaborator

•  Collaborator

•  Manager

Admin

•  Admin

Library Admin

•  Library Admin

•  Screener

•  Editor

•  Associate

Editor

•  Reviewer

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Uri the User

About -Uri registers for the site: he is interested in knowledge/research.

Use Cases -Uri wants to search and browse for files that are shared in public space, these files should be easy to find when looking for desired material. -Uri wants to search by file name, organization, tier, tags, type of file, or specialization sometimes, when he knows information about what he’s looking for. -After searching, Uri wants to be able to sort/restrict files, based on different traits (name, type, recent, reviews, etc.) -Finally, Uri wants to view details on the files and download them.

Nice to Have -Ability to review, a rating system -Comment/Discussion on each file

Concerns -easy to search and find files that are relevant -is the file useful/quality/reliable? -latest version of file

Will need to be registered with the site- software requirements, and EULA No access to project groups, unless approved.

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User

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Suzie the Submitter

About Suzie is interested in sharing information and through links and submissions. She submits files for the peer review process, she is allowed to do this because she has registered with the site.

Use Cases -Suzie knows of an outside resource that she believes is relevant to the library, she will share the link with the community, metadata is required. -Suzie wants to upload a collection of files at once to submission box, she knows all the relevant information about her collection to fill in the required metadata fields. -She want her files to be peer reviewed, and be able to receive feedback. -Suzie is interested in ongoing discussions on her files, notifications for comments.

Nice to Have -updates on files in the submission process

Concerns -can submissions be altered -can uploads be restricted to certain users (verified)

These files enter tier 2

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Submitter

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Cory the Collaborator

About Cory is a registered site user and authorized by a manager to be a collaborator in a group. Cory has an interest in sharing his knowledge and research publicly, also he wants to work privately with group members

Use Cases -Cory wants to search, sort, communicate, and download files, just like a public user, in his own group space. -Similar to Suzie the Submitter: Cory want to upload his own files and links to group space. He will be including the required metadata for the files. -Cory can also share files in the public space for tier 1 (non reviewed), because he wants feedback from the community, and he is a trusted user.

Nice to Have -a way to be alerted of conversations in group space: new topic, new files -similarly to public space –a way to comment on each file?

Concerns -easy to search and find files that are relevant, storing files in group -space is easy to use -convenient for communication, see replies and updates

Access is secure, group membership is approved, can be invited to group Tier 0: Can share files within the group space, they are seen only by group Tier 1: Being approved after meeting criteria grants the privilege of sharing files publicly.

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Collaborator

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Marla the Manager

About Marla is the leader of a group, she can manage members and files in her group space. Marla will submit files for review after they are completed group projects. Occasionally, Marla may want to grant the privilege for members to share publicly in the group. (This would be authorizing a user to be a collaborator and upload files – tier 1 files public to everyone, tier 0 only to your group) Use Cases -Marla is a manager of a tier 1 public group, she can make files public in tier 1, she can grant this ability to members, by approving them for this privilege. -Marla wants to upload files from her group to the submission box for tier 2. -She can add new members to her group at tier 0. -She can make members of her group users or collaborators, depending upon them meeting criteria to share files. -Marla wants to be able to control files in the group, and may need to remove unwanted/out dated items.

Nice to Have -updates on files submitted -quick sharing of files to move from group work to review

Concerns -can submissions be altered

This user can submit files that enter tier 1 or tier 2. can this be done easily by moving them from group to review, or will it be a separate upload?

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Manager

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Anna the Administrator

About Anna is the Salesforce Admin. She will have access to everything.

Use Cases -Will process requests for the site -Manages the site (members, files) -Can promote/demote users -Can add new users to the site Nice to Have -process to add users, send to outside email with access info -Easy to step in to the review roles and see the process

Concerns -Giving permissions to alternative admin (library Admin)

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Administrator

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Libby the Library Administrator

About Libby is restricted in admin permissions to the library. She can perform review roles and create a group space for a team, or for a specific project. She can assist in managing the files in the library. Other related users: possibly an Associate Admin, who will manage Library Operations, screening and managing user groups

Use Cases -Libby wants to have access to manage the working group spaces, invite members, approve membership to the group -Libby wants to assist in the review process, she can step in if needed, edit metadata, add content to tier 3

Nice to Have -group modification, suggested members, based on past groups? -be notified of excessive time in review process, if needed to step in -parts of work be automated, assigning editor, adding dates to metadata

Concerns -can membership requests be sent to outside emails? -follow the review process easily, see if there is a need for intervention -the ability to remove content

-get important updates to reach outside emails?

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Library Administrator

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Sam the Screener

Content Approver

About Sam wants to maintain a professional, uncluttered library. Sam will verify content before it enters the library. Sam will be the filter/screener, and in some cases, his role may be automated.

Use Cases -Sam wants to verify the metadata fields, are they correctly filled out, and possibly perform a basic check of file. Does it have everything necessary? -Sam wants to guarantee that files are clear for submission to public, or to the review process. -Sam wants to send the files to the correct place/person. Nice to Have -In some cases, Sam wants to be lazy, can there be a built-in system check for simple things (no missing fields, valid entry to field)

Concerns -with many files being submitted, want a quick turn around for submissions -files require download for extensive verification

At tier 0 and 1, this will be automated check by the system. At tier 2, this will require Sam to use his discretion.

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Screener

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Review Panel

Editor · Associate Editor · Reviewers

About Editor – receives submissions from user, move forward reviewing, assigns Associate Editor – receives from editor, assigns to reviewers Reviewers – receives from associate editor, check and verification

Use Cases -Wants a space to receive/view submissions -Start the process of reviewing -Decides on file submission, accept or reject (with comments?)

Nice to Have -a space for discussion, inbox for files -a timeline for progress

Concerns -submissions verified by content approver first

Processes Files for peer reviewed tier 2 www.storyboardthat.com

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Review Panel - Editor

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Review Panel – Associate Editor

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Review Panel – Reviewer

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Site Concept

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Home

Library

Advanced Search

Search Results

File Details

Groups

Find Groups

Group Page

Upload

Chatter Upload Search About Us

Site Overview – Basic Layout

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Home

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Home

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Home

Groups

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Library

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Examples of Searching

Sort files Tier 1 / Tier 2 / Tier 3

Tier 0

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Examples of Searching

Categories

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Examples of Searching

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Examples of Searching

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Examples of Searching

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Groups

See the groups you are a member of Find Groups

Not all users can make groups

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Find Groups

See groups you are a member of and public groups

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Group Page

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Group Page

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Group Page

Needs filtering and sorting

Possible folders for organization?

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Chatter

No option for files

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Uploading

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Uploading

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Collection Preview

Pdf Text JPG

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File Preview

Pdf Text JPG

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Peer Review Panel Privileges given when logged in

Possible tab in profile for review

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Information about the Metadata

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Metadata Fields Description How data is entered

Name A name given to the resource.

Keywords List of words that indicate content of resource.

Description Explanation of the role of this resource in context 3500 char text box

Type Resource type, like "geometric model," etc.

Device Area What category of medical devices does this apply to

Source From where was it derived

Creator Author

Contributor Submitter

Relation Related resource(s), such as part/whole, version

Coverage Date or date range (collected over a period)

Format File format Picklist with ‘other’ and a popup to fill in other or a subsequent validation step

Size File size Would require an interface action with S3, may not be. Could be picklist with range buckets.

Location File location (if link exists for an alternative location) This could be a rich field or just a textbox. The former allows for a clickable hyperlink.

Acquisition Date Date obtained (submitted to library) Created date from SF and last modified date from SF

Expected User Level Designed or intended for – expert, familiar, novice

Context of Use What is the intended use of this resource

State of Validation What type of validation has been carried out so far

Limitations

Quality or Condition General indication of the confidence in resource

References Companion works or important predecessors Text box

DOI?

Copyright?

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Metadata Fields Example How data is entered Name FDA Phantom Lung Nodule CT Image Database Keywords CT, computed tomography, lung, phantom, imaging Description A series of CT images acquired of an anthropomorphic lung phantom with inserted

nodules. Nodules vary in size, shape and location with known volume. The database consists of 634,256 images acquired on two commercial CT imaging systems

3500 char text box

Type Image data Device Area CT imaging devices, computer-aided diagnosis devices Source Image data acquired from phantom using commercial CT scanners Creator Marios Gavrielides Contributor Relation Database is still increasing with pending scans in 2014 Coverage 2007-2013 Format DICOM Picklist Size ~400Gb picklist with range buckets. Location https://wiki.cancerimagingarchive.net/display/Public/Phantom+FDA Hyperlink to an alternate location where

the data is located if not in the saleforce/S3 location. This could be a rich field or just a textbox. The former allows a hyperlink.

Acquisition Date 2007-2013 Created and last modified date from SF

Expected User Level Users familiar with the DICOM image format and have a basic understanding of CT imaging system parameters

Context of Use The development and testing of lung nodule size estimation software and related computer-aided diagnosis algorithms

State of Validation N/A (This is imaging data without associated claims of performance) Limitations Quality or Condition This is the result of a systematic approach to probe the most significant

imaging parameters and nodule characteristics affecting volumetric CT. The database has been utilized in several published studies and public algorithm challenges.

References Marios A Gavrielides , et al , “A resource for the assessment of lung nodule size estimation methods: database of thoracic CT scans of an anthropomorphic phantom”, Optics Express, vol. 18, n.14, pp. 15244-15255, 2010.

Text box, may also upload a reference list as a file but only the text box is searchable

Notes

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Metadata Fields Example How data is entered

Name MIDA

Keywords Magnetic Resonance Imaging||MRI||Voxel|| Diffusion Tensor Imaging||DTI||Head||Vessels

Description Multi-modal Imaging-based Detailed model of the Anatomy of the human head and neck. Consists of 115 anatomical structures. There are two files: (1) the RAW file contains information about each structure, i.e. the X, Y, Z coordinates of each voxel and a label assigned to the voxel; (2) the text file contains the description of the anatomical structure corresponding to the label. (See Abstract for more information: "A high-resolution anatomical head model functionalized with embedded dynamic neuron models is being developed. T1- and T2-weighted MR images at 0.5mm isotropic spatial resolution have been acquired to generate the head model. In addition, diffusion tensor images (DTI) have been acquired to identify the orientation of the brain nerve fibers.")

3500 char text box

Type Anatomical model

Device Area Head and neck

Source Magnetic Resonance Imaging, Diffusion Tensor Imaging, Magnetic Resonance Angiography

Creator Division of Physics [Maria Iacono, Leonardo Angelone, Wolfgang Kainz], Foundation for Research on Information Technologies in Society (IT'IS), Swiss Federal Institute of Technology (ETH) Zurich

Contributor Maria Iacono

Relation There are images associated with the model. Both the original data (the images) and the file of the model will be provided.

Coverage 2012  -­‐  Present  Format RAW||TXT   Picklist

Size Less  than  1  GB   picklist with range buckets.

Location Division  of  Physics  computer   rich field or just a textbox.

Acquisition Date Created and last modified date

Expected User Level Users who have a computational modeling background.

Context of Use Safety  of  pa8ents  with  implanted  neurological  devices.  Safety  of  pa8ents  during  head  imaging.  Effec8veness  of  neuros8mulators.  Educa8onal  tool  for  anatomy  classes.  Surgery-­‐planning.  Safety  of  focused  ultrasounds.  

State of Validation Verifica8on  against  anatomical  atlas.  Reviewed  by  expert  anatomist.  Limitations Lack  of  experimental  valida8on.  Model  limited  to  head  and  neck.  Quality or Condition The  model  is  in-­‐house  so  all  the  characteris8cs  and  limita8ons  are  well-­‐known.  References Manuscript  in  prepara8on.  Abstract  and  poster  presented  at  FDA.  ||Poster:  Maria  

Ida  Iacono,  Esther  Akinnagbe,  Esra  Neufeld  Johanna  Wolf,  Ethan  Cohen,  Eugene  Civillico,  Bertram  Wilm,  Michael  Wyss,  Klaas  Pruessmann,  Niels  Kuster,Wolfgang  Kainz,  Leonardo  M.  Angelone.  A  virtual  human  head  simulator  for  regulatory  science.  ||Abstract:  Maria  Ida  Iacono,  Esra  Neufeld,  Johanna  Wolf,  Ethan  Cohen,  Eugene  Civillico,  Esther  Akinnagbe,  Bertram  Wilm,  Michael  Wyss,  Klaas  Pruessmann,  Leonardo  M.  Angelone,  Niels  Kuster,Wolfgang  Kainz.  A  virtual  human  head  simulator  for  regulatory  science.  

Text box for a dump, may also upload a reference list as a file but only the text box is searchable

Notes

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Metadata Fields Example How data is entered

Name Nozzle  Model  (Benchmark)  -­‐  Geometry  Keywords CAD||Geometry||Idealized||Simplified||FDA  Nozzle  ||  CFD||  Axi-­‐symmetric  ||  

Sudden  expansion  ||  Sudden  contrac8on  Description Simplified  medical  device  model  used  as  a  benchmark  geometry  to  generate  

experimental  data  at  3  laboratories  for  comparison  to  CFD  simula8ons  3500 char text box

Type Geometric  model  Device Area The  nozzle  shares  characteris8cs  of  blood  contac8ng  medical  devices  in  which  the  

flow  field  dimensions  vary,  for  example,  at  blood  tubing  connec8ons,  in  the  header  regions  of  hemodialysis  and  cardiopulmonary  devices,  and  within  catheters,  cannulas,  syringes,  and  hypodermic  needles.  The  flow  fields  generated  by  this  model  also  resemble  flow  pa]erns  commonly  seen  in  other  cardiovascular  devices  such  as  ar8ficial  heart  valves  (downstream  jet)  and  centrifugal  blood  pumps  (cutwater  and  diffuser  regions)    

Source FDA  (as  part  of  an  interlaboratory  study)  Creator FDA

Contributor FDA

Relation The  nozzle  model  geometry  was  used  to  generate  experimental  data  (see  separate  entry)  for  comparison  to  CFD  simula8ons  under  specific  flow  condi8ons.  

Coverage 01/2008  -­‐  01/2009  (dates  when  the  physical  model  was  fabricated  and  checked  for  quality)  

Format igs,  sat,  stp  (3D  CAD  file  formats)   Picklist

Size 300KB   picklist with range buckets.

Location

h]ps://fdacfd.nci.nih.gov/interlab_study_1_nozzle/documenta8on  

rich field or just a textbox. The former allows for a clickable hyperlink.

Acquisition Date March  2014   Created date from SF and last modified date from SF

Expected User Level It  is  designed  for  all  types  of  users.  Some  basic  knowledge  of  fluid  mechanics,  turbulence,  CFD,  CAD  and  meshing  soeware  is  necessary.  

Context of Use As  a  benchmark  geometric  model  for  CFD  simula8ons;  the  CFD  simula8ons  can  provide  pressure,  velocity,  shear  stress,  and  blood  damage  predic8ons.  These  predic8ons  can  be  compared  to  inter-­‐laboratory  experimental  data.  The  experimental  dataset  can  be  downloaded  from  this  library  

State of Validation This  resource  only  contains  the  geometry  defini8on  files.  All  dimensions  in  this  geometry  closely  match  the  dimensions  measured  from  the  physical  models  (within  a  1%  tolerance  for  the  dimensional  specifica8ons  of  inlet,  throat,  and  exit  diameters).  The  physical  models  were  used  for  performing  velocity,  pressure,  and  blood  damage  measurements.    

Limitations

Quality or Condition We  have  a  high  degree  of  confidence  in  the  fact  that  the  dimensions  provided  in  this  CAD  file  closely  resemble  the  dimensions  in  the  fabricated  physical  models  (within  1%).  

References References  i)h]ps://fdacfd.nci.nih.gov    ii)  Hariharan,  P.,  Giarra,  M.,  Reddy,  V.,  Day,  S.,  Manning,  K.  B.,  Deutsch,  S.,  Stewart,  S.  F.  C.,        Myers,  M.  R.,  Berman,  M.  R.,  Burgreen,  G.  W.,  Paterson,  E.  G.,  and  Malinauskas,  R.  A.,  2011,  “Mul8-­‐laboratory  Par8cle  Image  Velocimetry  Analysis  of  the  FDA  Benchmark  Nozzle  Model  to  Support  Valida8on  of  Computa8onal  Fluid  Dynamics  Simula8ons,”  ASME  J.  Biomech.  Eng.,  133,  pp.  041002-­‐1-­‐041002-­‐13  iii)  Stewart  SFC,  Paterson  EG,  Burgreen  GW,  Hariharan  P,  Day  S,  Manning  KB,  Deutsch  S,  Giarra  M,  Reddy  V,  Berman  MR,  Myers  MR,  Malinauskas  RA,  “Assessment  of  CFD  Performance  in  Simula8ons  of  an  Idealized  Medical  Device  -­‐  Results  of  FDA's  Computa8onal  Interlaboratory  Study”,  2011,  Cardiovascular  Engineering  and  Technology,  3(2),  139-­‐160.  iv)  Stewart  SFC,  Hariharan  P,  Malinauskas  RA,  “Results  of  FDA's  First  Interlaboratory  Computa8onal  Study  Of  A  Nozzle  With  A  Sudden  Contrac8on  And  Conical  Diffuser”,  2013,  Cardiovascular  Engineering  and  Technology,  4(4),  374-­‐391.  

Text box for a dump, may also upload a reference list as a file but only the text box is searchable

Notes

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Metadata Fields Example How data is entered

Name Nozzle  Model  (Benchmark)  -­‐  Experimental  Data  Keywords Idealized||Simplified  ||  FDA  Nozzle  ||CFD||  Sudden  expansion  ||  Sudden  

Contrac8on  ||  Diffuser  ||  Experimental  valida8on||  Par8cle  Image  Velocimetry  ||Velocity  measurement    ||  Pressure  measurement  ||  Transi8onal  flow  ||  Turbulent  flow  measurement  ||  Flow  separa8on  ||  FDA  cri8cal  path  ini8a8ve  

Description This  resource  provides  the  hydrodynamic  experimental  data  to  validate  CFD  simula8ons  performed  on  the  FDA  nozzle  model  under  defined  tes8ng  condi8ons  

3500 char text box

Type Experimental  data  (velocity  field,  pressure)  Device Area The  nozzle  shares  characteris8cs  of  blood  contac8ng  medical  devices  in  which  the  

flow  field  dimensions  vary,  for  example,  at  blood  tubing  connec8ons,  in  the  header  regions  of  hemodialysis  and  cardiopulmonary  devices,  and  within  catheters,  cannulas,  syringes,  and  hypodermic  needles.  The  flow  fields  generated  by  this  model  also  resemble  flow  pa]erns  commonly  seen  in  other  cardiovascular  devices  such  as  ar8ficial  heart  valves  (downstream  jet)  and  centrifugal  blood  pumps  (cutwater  and  diffuser  regions)    

Source Under  the  direc8on  of  FDA,  experiments  were  performed  at  the  following  laboratories:  FDA,  Pennsylvania  State  University,  Rochester  Ins8tute  of  Technology.  

Creator FDA

Contributor FDA

Relation The  experimental  data  was  derived  as  part  of  an  FDA  Cri8cal  Path  Ini8a8ve  project  to  evaluate  the  use  of  CFD  simula8ons  as  applied  to  medical  devices.  

Coverage 01/2009  -­‐  12/2009  (dates  when  the  experimental  data  were  obtained)  Format txt  files  compressed  in  zip  format     Picklist

Size 3500  KB   picklist with range buckets.

Location h]ps://fdacfd.nci.nih.gov/interlab_study_1_nozzle/data   rich field or just a textbox

Acquisition Date March  2014   Created date from SF and last modified date from SF

Expected User Level The  dataset  can  be  used  by  all  types  of  users.    Some  basic  knowledge  of  fluid  mechanics,  velocity  and  pressure  measurements,  turbulence,  CFD  (computa8onal  fluid  dynamics),  and  CAD  would  be  useful.  

Context of Use The  experimental  dataset  is  intended  to  be  used  for  valida8ng  pressure  and  velocity  predic8ons  made  by  CFD  simula8ons  performed  on  the  FDA  nozzle  model  under  defined  test  condi8ons.  

State of Validation This  resource  only  contains  the  geometry  defini8on  files.  All  dimensions  in  this  geometry  closely  match  the  dimensions  measured  from  the  physical  models  (within  a  1%  tolerance  for  the  dimensional  specifica8ons  of  inlet,  throat,  and  exit  diameters).  The  physical  models  were  used  for  performing  velocity,  pressure,  and  blood  damage  measurements.    

Limitations

Quality or Condition We  have  a  high  degree  of  confidence  in  the  fact  that  the  dimensions  provided  in  this  CAD  file  closely  resemble  the  dimensions  in  the  fabricated  physical  models  (within  1%).  

References References  i)h]ps://fdacfd.nci.nih.gov    ii)  Hariharan,  P.,  Giarra,  M.,  Reddy,  V.,  Day,  S.,  Manning,  K.  B.,  Deutsch,  S.,  Stewart,  S.  F.  C.,        Myers,  M.  R.,  Berman,  M.  R.,  Burgreen,  G.  W.,  Paterson,  E.  G.,  and  Malinauskas,  R.  A.,  2011,  “Mul8-­‐laboratory  Par8cle  Image  Velocimetry  Analysis  of  the  FDA  Benchmark  Nozzle  Model  to  Support  Valida8on  of  Computa8onal  Fluid  Dynamics  Simula8ons,”  ASME  J.  Biomech.  Eng.,  133,  pp.  041002-­‐1-­‐041002-­‐13  iii)  Stewart  SFC,  Paterson  EG,  Burgreen  GW,  Hariharan  P,  Day  S,  Manning  KB,  Deutsch  S,  Giarra  M,  Reddy  V,  Berman  MR,  Myers  MR,  Malinauskas  RA,  “Assessment  of  CFD  Performance  in  Simula8ons  of  an  Idealized  Medical  Device  -­‐  Results  of  FDA's  Computa8onal  Interlaboratory  Study”,  2011,  Cardiovascular  Engineering  and  Technology,  3(2),  139-­‐160.  iv)  Stewart  SFC,  Hariharan  P,  Malinauskas  RA,  “Results  of  FDA's  First  Interlaboratory  Computa8onal  Study  Of  A  Nozzle  With  A  Sudden  Contrac8on  And  Conical  Diffuser”,  2013,  Cardiovascular  Engineering  and  Technology,  4(4),  374-­‐391.  

Text box for a dump, may also upload a reference list as a file but only the text box is searchable

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