【摘要】 囊胚形态人工智能(AI)评估是AI医疗器械发展的新兴方向，也是AI在辅助生殖领域的重要应用。AI在新领域应用的起步阶段，数据集的构建与质控对产品质量有重要影响。目前，囊胚形态学AI评估在数据采集、标注、质控等方面尚未形成统一的规范。在参考AI医疗器械、辅助生殖医疗器械现有国家行业标准的基础上，本文以囊胚形态AI评估数据集为主题，对数据集构建与质控要求进行了探讨，对数据集质量特性进行了解析，旨在指导数据集制造责任方加强数据集全生命周期管理，更好地为产品研发、测试、临床试验等环节提供质量保障，助力产业发展。更多还原

【Abstract】 Computer assisted assessment of blastocyst morphology is an emerging direction in the artificial intelligence(AI) medical devices and an important application of AI in the field of assisted reproduction. In the initial stage of the application of AI in new fields, the construction and quality control of data sets have an important impact on product quality. At present, AI-assisted blastocyst morphology assessment has not yet formed a unified specification in terms of data collection, labeling, and quality control. Based on the existing national industry standards for AI medical devices and assisted reproduction medical devices, this paper discusses the requirements for data set construction and quality control and analyzes the quality characteristics of data sets with the theme of blastocyst morphology assessment datasets, with the aim of guiding data set manufacturers to strengthen the management of datasets in the whole life cycle, and to better provide quality assurance for the product research and development, testing, and clinical trials in order to help the development of the industry.更多还原