PubMed

Anwendung von LLMs zur Analyse von AI/ML-Zulassungen medizinischer Geräte.

PMID: 40776237 · 2025-08-07

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ZeitschriftStudies in health technology and informatics

Jahr2025-08-07

PMID40776237

Zusammenfassung

Machine learning (ML) is increasingly being integrated into medical devices. However, the functionality and clinical use of ML within these devices remains unclear, raising safety concerns. Manual analysis of FDA approval documents provides insights but is inefficient. This study explores the feasibility of using large language models (LLMs) to automate such analyses. We evaluate LLMs based on architecture, training strategies, parameter sizes, computational demands, and output quality to extrac

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