A recent analysis of AI products for radiology, published in Insights Into Imaging underscores the critical need for clarity and transparency in the use of AI in healthcare.
The analysis covered 156 intended use statements of AI products for radiology. These statements, which are mandatory for regulatory clearance, define how an AI solution can be used in clinical practice.
A significant 95% of these statements were found to be incomplete, indicating a lack of crucial information. Furthermore, 9% of the statements contained disclaimers that contradicted the claims of the AI product.
Intended use statements publicly available
Unlike the FDA, there is currently no central repository for intended use statements for CE marked devices. Unfortunately, this is also not included in the new Eudamed platform from the European Commission.
Therefore, for this study, they were collected directly from the vendors.
To promote the safe and effective use of AI, we advocate for making these intended use statements publicly accessible. With the consent of the vendors, these statements are now available on the product pages.
We hope this initiative will enhance the quality and clarity of these statements, aiding healthcare professionals in understanding how, for whom, and under what conditions the AI solution should be used.
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Abstract
Background
Intended use statements (IUSs) are mandatory to obtain regulatory clearance for artificial intelligence (AI)-based medical devices in the European Union. In order to guide the safe use of AI-based medical devices, IUSs need to contain comprehensive and understandable information. This study analyzes the IUSs of CE-marked AI products listed on AIforRadiology.com for ambiguity and completeness.
Methods
We retrieved 157 IUSs of CE-marked AI products listed on AIforRadiology.com in September 2022. Duplicate products (n = 1), discontinued products (n = 3), and duplicate statements (n = 14) were excluded. The resulting IUSs were assessed for the presence of 6 items: medical indication, part of the body, patient population, user profile, use environment, and operating principle. Disclaimers, defined as contra-indications or warnings in the IUS, were identified and compared with claims.
Results
Of 139 AI products, the majority (n = 78) of IUSs mentioned 3 or less items. IUSs of only 7 products mentioned all 6 items. The intended body part (n = 115) and the operating principle (n = 116) were the most frequently mentioned components, while the intended use environment (n = 24) and intended patient population (n = 29) were mentioned less frequently. Fifty-six statements contained disclaimers that conflicted with the claims in 13 cases.
Conclusion
The majority of IUSs of CE-marked AI-based medical devices lack substantial information and, in few cases, contradict the claims of the product.
Critical relevance statement
To ensure correct usage and to avoid off-label use or foreseeable misuse of AI-based medical devices in radiology, manufacturers are encouraged to provide more comprehensive and less ambiguous intended use statements.