Artificial Intelligence (AI) and Machine-Learning (ML) models have been increasingly used in medical products, such as medical device software. General considerations on the statistical aspects for the evaluation of AI/ML-enabled medical diagnostic devices are discussed in this paper. We also provide relevant academic references and note good practices in addressing various statistical challenges in the clinical validation of AI/ML-enabled medical devices in the context of their intended use.

翻译：人工智能（AI）与机器学习（ML）模型已被日益广泛应用于医疗器械软件等医疗产品中。本文探讨了AI/ML赋能医疗诊断设备评估中统计学方面的通用考量，并提供了相关学术参考文献，同时指出了针对此类设备在预期用途背景下临床验证过程中多种统计学挑战的实践要旨。