How AI should be used in radiology: assessing ambiguity and completeness of intended use statements of commercial AI products.
Kicky G van LeeuwenDennis M HedderichHugh HarveySteven SchalekampPublished in: Insights into imaging (2024)
• 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.