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. 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. 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. The majority of IUSs of CE-marked AI-based medical devices lack substantial information and, in few cases, contradict the claims of the product. 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. • 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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人工智能应如何应用于放射学：评估商业人工智能产品预期用途声明的模糊性和完整性

为了获得欧盟基于人工智能 (AI) 的医疗设备的监管许可，必须提供预期用途声明 (IUS)。为了指导基于人工智能的医疗设备的安全使用，IUS 需要包含全面且易于理解的信息。本研究分析了 AIforRadiology.com 上列出的带有 CE 标志的人工智能产品的 IUS 的模糊性和完整性。我们检索了 2022 年 9 月在 AIforRadiology.com 上列出的 157 个带有 CE 标志的 AI 产品的 IUS。重复产品 (n = 1)、停产产品 (n = 3) 和重复声明 (n = 14) 被排除。对所得的 IUS 进行了 6 项评估：医学适应症、身体部位、患者群体、用户概况、使用环境和操作原理。免责声明被定义为 IUS 中的禁忌症或警告，并与声明进行比较。在 139 个人工智能产品中，大多数（n = 78）IUS 提到了 3 个或更少的项目。只有 7 种产品的 IUS 提到了全部 6 项。预期的身体部位 (n = 115) 和操作原理 (n = 116) 是最常被提及的组成部分，而预期的使用环境 (n = 24) 和预期的患者群体 (n = 29) 则提及较少。 56 份声明包含与 13 起案件中的主张相冲突的免责声明。大多数带有 CE 标志的人工智能医疗设备 IUS 缺乏大量信息，并且在少数情况下与产品的声明相矛盾。为了确保正确使用并避免在放射学中超说明书使用或可预见的误用基于人工智能的医疗设备，鼓励制造商提供更全面、更明确的预期用途声明。 • 放射科医生必须了解人工智能产品的预期用途，以避免标签外使用或误用。 • 所分析的预期用途声明中有百分之九十五 (n = 132/139) 不完整。 • 百分之九（n = 13）的预期用途声明包含与人工智能产品的声明相矛盾的免责声明。 • 制造商和监管机构必须确保预期用途声明的全面性。