Musculoskeletal Biomechanics Research Lab, Department of Mechanical Engineering, McGill University, Montreal, QC, H3A 0C3, Canada.
Orthopaedic Research Laboratory, Research Institute MUHC, Montreal General Hospital, Montreal, QC, H3G 1A4, Canada.
Ann Biomed Eng. 2023 Jan;51(1):150-162. doi: 10.1007/s10439-022-03069-x. Epub 2022 Sep 10.
The ability of new medical devices and technology to demonstrate safety and effectiveness, and consequently acquire regulatory approval, has been dependent on benchtop, in vitro, and in vivo evidence and experimentation. Regulatory agencies have recently begun accepting computational models and simulations as credible evidence for virtual clinical trials and medical device development. However, it is crucial that any computational model undergo rigorous verification and validation activities to attain credibility for its context of use before it can be accepted for regulatory submission. Several recently published numerical models of the human spine were considered for their implementation of various comparators as a means of model validation. The comparators used in each published model were examined and classified as either an engineering or natural comparator. Further, a method of scoring the comparators was developed based on guidelines from ASME V&V40 and the draft guidance from the US FDA, and used to evaluate the pertinence of each comparator in model validation. Thus, this review article aimed to score the various comparators used to validate numerical models of the spine in order to examine the comparator's ability to lend credibility towards computational models of the spine for specific contexts of use.
新的医疗设备和技术在展示其安全性和有效性，并因此获得监管批准方面的能力，一直依赖于台架、体外和体内的证据和实验。监管机构最近开始接受计算模型和模拟作为虚拟临床试验和医疗器械开发的可信证据。然而，至关重要的是，在接受监管提交之前，任何计算模型都必须经过严格的验证和验证活动，以获得其使用背景的可信度。考虑了最近发表的几种人类脊柱的数值模型，以评估它们在模型验证中对各种比较器的实现情况。检查并将每个已发表模型中使用的比较器分类为工程比较器或自然比较器。此外，根据 ASME V&V40 的指南和美国 FDA 的指南草案，开发了一种评分比较器的方法，并用于评估每个比较器在模型验证中的相关性。因此，本文旨在对用于验证脊柱数值模型的各种比较器进行评分，以检验比较器在特定使用背景下为脊柱的计算模型提供可信度的能力。
