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arXiv · 2505.00422

Toward Automated Regulatory Decision-Making: Trustworthy Medical Device Risk Classification with Multimodal Transformers and Self-Training

Yu Han·Aaron Ceross·Jeroen H. M. Bergmann
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Abstract

Accurate classification of medical device risk levels is essential for regulatory oversight and clinical safety. We present a Transformer-based multimodal framework that integrates textual descriptions and visual information to predict device regulatory classification. The model incorporates a cross-attention mechanism to capture intermodal dependencies and employs a self-training strategy for improved generalization under limited supervision. Experiments on a real-world regulatory dataset demonstrate that our approach achieves up to 90.4% accuracy and 97.9% AUROC, significantly outperforming text-only (77.2%) and image-only (54.8%) baselines. Compared to standard multimodal fusion, the self-training mechanism improved SVM performance by 3.3 percentage points in accuracy (from 87.1% to 90.4%) and 1.4 points in macro-F1, suggesting that pseudo-labeling can effectively enhance generalization under limited supervision. Ablation studies further confirm the complementary benefits of both cross-modal attention and self-training.

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Yu Han, Aaron Ceross, Jeroen H. M. Bergmann. 2025-05-01. Toward Automated Regulatory Decision-Making: Trustworthy Medical Device Risk Classification with Multimodal Transformers and Self-Training. https://arxiv.org/abs/2505.00422

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