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arXiv · 2303.05399

Practical Statistical Considerations for the Clinical Validation of AI/ML-enabled Medical Diagnostic Devices

Feiming Chen·Hong Laura Lu·Arianna Simonetti
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Abstract

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.

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Feiming Chen, Hong Laura Lu, Arianna Simonetti. 2023-03-02. Practical Statistical Considerations for the Clinical Validation of AI/ML-enabled Medical Diagnostic Devices. https://arxiv.org/abs/2303.05399

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