Novel products applying artificial intelligence (AI)-based methods to digital pathology images are touted to have many uses and benefits. However, publicly available information for products can be variable, with few sources of independent evidence. This review aimed to identify public evidence for AI-based products for digital pathology. Key features of products on the European Economic Area/Great Britain (EEA/GB) markets were examined, including their regulatory approval, intended use, and published validation studies. There were 26 AI-based products that met the inclusion criteria and, of these, 24 had received regulatory approval via the self-certification route as General in vitro diagnostic (IVD) medical devices. Only 10 of the products (38%) had peer-reviewed internal validation studies and 11 products (42%) had peer-reviewed external validation studies. To support transparency an online register was developed using identified public evidence (https://osf.io/gb84r/), which we anticipate will provide an accessible resource on novel devices and support decision making.

将基于人工智能 （AI） 的方法应用于数字病理图像的新产品被吹捧为具有许多用途和好处。但是，商品的公开信息可能各不相同，独立证据来源很少。本综述旨在确定基于 AI 的数字病理学产品的公共证据。检查了欧洲经济区/英国 （EEA/GB） 市场上产品的主要特征，包括其监管批准、预期用途和已发布的验证研究。有 26 种基于 AI 的产品符合纳入标准，其中 24 种已通过自我认证途径获得监管批准，成为一般体外诊断 （IVD） 医疗器械。只有 10 种产品 （38%） 进行了同行评审的内部验证研究，11 种产品 （42%） 进行了同行评审的外部验证研究。为了支持透明度，我们使用已识别的公共证据 （https://osf.io/gb84r/） 开发了在线登记册，我们预计这将提供有关新设备的可访问资源并支持决策。