Health

Normalized risk-based evaluation of machine learning-based classification models: A multiclass approach with applications in medical devices

ObjectiveMachine learning is increasingly integrated into safety-critical domains such as medical applications. In this context, regulatory frameworks require the assessment and minimization of risks associated with incorrect model predictions. However, classical evaluation methods often focus on quantifying error frequencies, which do not reflect the heterogeneous impact of different types of errors. To address this deficiency, we elaborate an approach for assessing machine learning-based multiclass classificat…