Abstract
Corrupted, inconsistent, or anomalous data silently threatens the safety and reliability of medical AI. Despite growing regulatory recognition of dataset quality assurance (QA) for high-risk medical AI, scalable automated detection remains underdeveloped. We employ unsupervised anomaly detection (AD) and out-of-distribution (OOD) detection as an automated dataset QA mechanism for multi-center dynamic contrast-enhanced breast MRI. We build a controlled AD benchmark of 17 realistic QA-relevant anomaly types from six public datasets (protocol violations, processing errors, incorrect anatomical regions) and propose a taxonomy of radiological image anomalies based on human visual perception, enabling fine-grained analysis of AD failure modes. The benchmark includes near-, medium-far-, far-OOD samples, as well as in-distribution and external normal data. Four methods are evaluated: a projection-based method extended with a domain-specific feature extractor and a novel positional encoding, a reconstruction-based approach extended to full 3D volumes with an augmented training objective, and two unmodified hybrid OOD detection methods. Medium-far- and far-OOD samples are detected reliably, whereas near-OOD samples and external normal data from unseen institutions expose method-specific differences. The 3D reconstruction-based approach best balances detection performance (AUROC: 0.936) and generalization to unseen institutions. The projection-based method with positional encoding achieves the highest overall detection performance (AUROC: 0.954). Both hybrid methods exhibit critical failure modes, confirming that methods validated for one modality or anatomy may not generalize without domain-specific adaptation. Implants and mastectomies remain an open challenge for all methods. Our results establish a foundation and practical guidance on scalable unsupervised QA in medical AI pipelines.
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URL
https://arxiv.org/abs/2608.16725
