About ACR’s Data Science Institute AI Central

Since 2018, the ACR Data Science Institute® AI Central database has evolved from a short online list of FDA-cleared imaging AI products to the most complete and current online searchable directory of commercially available imaging AI products in the U.S. More than 200 SaMD FDA-cleared products have been curated by more than 100 manufacturers, and thousands of radiologists per month are accessing the site in search of suitable AI solutions. ACR® recently launched a new service to expand offerings in AI Central.

Transparent-AI

Transparent-AI is a free program composed of data elements voluntarily provided by manufacturers to drive more transparency about Imaging AI algorithms, including how they were developed and validated. This program is designed to help end users have better informed discussions and selection criteria when making decisions about which algorithm might be most appropriate for their local target population. Manufacturers participating in the program will have the Transparent-AI badge displayed on their product tiles and profiles.

The transparency content will be posted on AI Central and include data that fall within the following general categories: Model Identification, Characteristics, Indications for Use, Performance, Training Details and Limitations. Examples of data elements include intended user, age range, scanner manufacturer and scanner models used in stand-alone performance. The Instructions for Use (IFU), an FDA-required document that already contains much of the discrete data referenced above, will be included for each product.

FAQs
  1. My product is not listed on AI Central. What should I do?

    Please email DSI@acr.org with your product name and FDA 510(k) submission number to have your product reviewed and added to AI Central.

  2. What is Transparent-AI?

    Transparent-AI is a free program composed of data elements voluntarily provided by manufacturers to drive more transparency about Imaging AI algorithms, including how they were developed and validated. This program is designed to help end users have better informed discussions when making decisions about which algorithm might be most appropriate for their local target population.

  3. How can I join Transparent-AI?

    Interested in Transparent-AI? Please reach out to the ACR at dsi@acr.org or 800.227.5463 for next steps.

  4. What is an FDA cleared SaMD?

    SaMD stands for Software as a Medical Device.

  5. What does it mean when a product has the Transparent-AI badge displayed?

    This means the manufacturer is participating in our Transparent-AI program and has provided the necessary data elements about how their product was developed and validated.

Questions about product information:
  1. What is the meaning of Category and its values?
    1. MIMPS: Medical Image Management and Processing Systems
    2. CADt: Computer-assisted triage and notification
    3. CADe: Computer-assisted detection
    4. CADx: Computer-assisted diagnostic
    5. CADe/x: Computer-assisted detection/diagnosis
  2. What does Predicate Device mean?

    A predicate device is an FDA cleared medical device used as point of comparison for new medical devices seeking approval through FDA’s 510(k) pre-market clearance pathway.

  3. What are related use cases?

    Related use cases refer to DSI use cases. DSI use cases are scenarios where AI may help improve medical imaging care.

  4. What are available marketplace(s)?

    Available marketplace(s) refer to available platform vendors that list specific products.

  5. Why do only some products have the Transparent-AI badge?

    The Transparent-AI badge is only given to manufacturers that provide a set of required data elements that indicate how their product was created and tested.

  6. Why do some elements on product details page have the value “Unspecified”?

    All data values on the product details page are extracted from the FDA summary. If the information is not available in the summary, then we define it as “Unspecified."