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

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 provid...

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Bibliographic Details
Published in:arXiv.org 2023-03
Main Authors: Chen, Feiming, Hong Laura Lu, Simonetti, Arianna
Format: Article
Language:English
Subjects:
Artificial intelligence
Machine learning
Medical devices
Medical electronics
Online Access:Get full text
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Summary: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.
ISSN:2331-8422