Risk-based evaluation of machine learning-based classification methods used for medical devices.

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.

Methods

First, we analyzed how often risk-based metrics are currently utilized in the context of ML-based classification models. This was performed using a literature research based on a sample of recent scientific publications. Second, we introduce an approach for evaluating such models where expected risks and associated

SUBMITTER: Haimerl M 

PROVIDER: S-EPMC11895222 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature