Risk-based evaluation of machine learning-based classification methods used for medical devices.
Journal:
BMC medical informatics and decision making
PMID:
40069689
Abstract
BACKGROUND: In the future, more medical devices will be based on machine learning (ML) methods. In general, the consideration of risks is a crucial aspect for evaluating medical devices. Accordingly, risks and their associated costs should be taken into account when assessing the performance of ML-based medical devices. This paper addresses the following three research questions towards a risk-based evaluation with a focus on ML-based classification models.