Article: How AI should be used in radiology: assessing ambiguity and completeness of intended use statements of commercial AI products.
2024 Volume 15, Issue 1, Page(s) 51
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 ... ...
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. Key points: • Radiologists must know AI products' intended use to avoid off-label use or misuse. • Ninety-five percent (n = 132/139) of the intended use statements analyzed were incomplete. • Nine percent (n = 13) of the intended use statements held disclaimers contradicting the claim of the AI product. • Manufacturers and regulatory bodies must ensure that intended use statements are comprehensive. |
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Language | English |
Publishing date | 2024-02-16 |
Publishing country | Germany |
Document type | Journal Article |
ZDB-ID | 2543323-4 |
ISSN | 1869-4101 |
ISSN | 1869-4101 |
DOI | 10.1186/s13244-024-01616-9 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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