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arXiv 2409.04794cs.LGcs.CY
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超越一次性验证:一种用于预后和诊断性AI医疗器械自适应验证的框架

Beyond One-Time Validation: A Framework for Adaptive Validation of Prognostic and Diagnostic AI-based Medical Devices

x-cardiac GmbH(x-cardiac有限公司);University of Tübingen(图宾根大学);Deutsches Herzzentrum der Charité(夏里特德国心脏中心);German Centre for Cardiovascular Research(德国心血管研究中心);Berlin Institute for the Foundations of Learning and Data(柏林学习与数据基础研究所)

Florian Hellmeier, Kay Brosien, Carsten Eickhoff, Alexander Meyer

AI总结:

针对AI医疗器械真实世界持续运行的验证难题,本文提出强调部署期重复验证与微调、并适应机构和流程变化的自适应验证框架,结合美欧监管要求说明其实用价值。

摘要:

预后和诊断性基于AI的医疗器械在推动医疗保健发展方面具有巨大前景,但其快速发展已经超过了适当验证方法的建立。现有方法往往不足以应对实际部署这些设备的复杂性,也不足以确保其在真实世界环境中有效、持续地运行。基于近期围绕医学中AI模型验证的讨论,并借鉴其他领域的验证实践,本文提出了一个用于弥补这一差距的框架。它提供了一种结构化、稳健的验证方法,有助于确保设备在不同临床环境中的可靠性。文中讨论了部署后设备性能面临的主要挑战,同时强调了与各个医疗机构和运营流程相关的变化所产生的影响。所提出的框架强调在部署期间重复验证和微调的重要性,旨在缓解这些问题,并能够适应设备开发过程中未预见的挑战。该框架还被置于当前美国和欧盟的监管环境中加以定位,突显出其在监管要求方面的实践可行性和相关性。此外,本文给出了一个实际示例,展示该框架的潜在收益。最后,文中提供了关于评估模型性能的指导,并讨论了让临床利益相关方参与验证和微调过程的重要性。

英文摘要:

Prognostic and diagnostic AI-based medical devices hold immense promise for advancing healthcare, yet their rapid development has outpaced the establishment of appropriate validation methods. Existing approaches often fall short in addressing the complexity of practically deploying these devices and ensuring their effective, continued operation in real-world settings. Building on recent discussions around the validation of AI models in medicine and drawing from validation practices in other fields, a framework to address this gap is presented. It offers a structured, robust approach to validation that helps ensure device reliability across differing clinical environments. The primary challenges to device performance upon deployment are discussed while highlighting the impact of changes related to individual healthcare institutions and operational processes. The presented framework emphasizes the importance of repeating validation and fine-tuning during deployment, aiming to mitigate these issues while being adaptable to challenges unforeseen during device development. The framework is also positioned within the current US and EU regulatory landscapes, underscoring its practical viability and relevance considering regulatory requirements. Additionally, a practical example demonstrating potential benefits of the framework is presented. Lastly, guidance on assessing model performance is offered and the importance of involving clinical stakeholders in the validation and fine-tuning process is discussed.

机构、总结、中文摘要均由AI分析而来,可能存在错误,请以论文正文为准。

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