How AI should be used in radiology: assessing ambiguity and completeness of intended use statements of commercial AI products

ConclusionThe 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 statementTo 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.Graphical Abstract

http://link.springer.com/10.1186/s13244-024-01616-9

Source: Insights into Imaging - February 16, 2024 Category: Radiology Source Type: research