Baumann Andrew P, Graf Thomas, Peck Jonathan H, Dmitriev Anton E, Coughlan Dezba, Lotz Jeffrey C
Office of Science and Engineering Laboratories, Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring Maryland USA.
Office of Product Evaluation and Quality, Center for Devices and Radiological Health U.S. Food and Drug Administration Silver Spring Maryland USA.
JOR Spine. 2021 Jan 13;4(1):e1137. doi: 10.1002/jsp2.1137. eCollection 2021 Mar.
Intervertebral body fusion devices (IBFDs) are a widely used type of spinal implant placed between two vertebral bodies to stabilize the spine for fusion in the treatment of spinal pathologies. Assessing mechanical performance of these devices is critical during the design, verification, and regulatory evaluation phases of development. While traditionally evaluated with physical bench testing, empirical assessments are at times supplemented with computational models and simulations such as finite element analysis (FEA). However, unlike many mechanical bench tests, FEA lacks standardized practices and consistency of implementation.
The objectives of this study were twofold. First, to identify IBFD 510(k) submissions containing FEA and conduct a comprehensive review of the elements provided in the FEA reports. Second, to engage with spinal device manufacturers through an anonymous survey and assess their practices for implementing FEA.
First, a retrospective analysis of 510(k) submissions for IBFDs cleared by the FDA between 2013 and 2017 was performed. The contents of FEA test reports were quantified according to FDA guidance. Second, a survey inquiring about the use of FEA was distributed to industry and academic stakeholders. The survey asked up to 20 questions relating to modeler experience and modeling practices.
Significant gaps were present in model test reports that deemed the data unreliable and, therefore, unusable for regulatory decision-making in a high percentage of submissions. Nonetheless, the industry survey revealed most stakeholders employ FEA during device evaluation and are interested in more prescriptive guidelines for executing IBFD models.
This study showed that while inconsistencies and gaps in FEA execution do exist within the spinal device community, the stakeholders are eager to work together in developing standardized approaches for executing computational models to support mechanical performance assessment of spinal devices in regulatory submissions.
椎间融合器（IBFDs）是一种广泛应用的脊柱植入物，放置在两个椎体之间，用于稳定脊柱以促进融合，治疗脊柱疾病。在这些器械的设计、验证和监管评估阶段，评估其力学性能至关重要。传统上通过物理台架试验进行评估，但有时经验性评估会辅以计算模型和模拟，如有限元分析（FEA）。然而，与许多机械台架试验不同，FEA缺乏标准化的实践和实施的一致性。
本研究有两个目的。第一，识别包含FEA的IBFD 510(k)提交文件，并对FEA报告中提供的要素进行全面审查。第二，通过匿名调查与脊柱器械制造商接触，评估他们实施FEA的实践。
首先，对2013年至2017年期间美国食品药品监督管理局（FDA）批准的IBFDs的510(k)提交文件进行回顾性分析。根据FDA指南对FEA测试报告的内容进行量化。其次，向行业和学术利益相关者发放了一份关于FEA使用情况的调查问卷。该调查提出了多达20个与建模人员经验和建模实践相关的问题。
模型测试报告中存在重大差距，这使得数据不可靠，因此在很大比例的提交文件中无法用于监管决策。尽管如此，行业调查显示，大多数利益相关者在器械评估过程中采用FEA，并且对执行IBFD模型的更具规范性的指南感兴趣。
本研究表明，虽然脊柱器械领域在FEA执行方面确实存在不一致和差距，但利益相关者渴望共同努力制定标准化方法来执行计算模型，以支持脊柱器械在监管提交文件中的力学性能评估。
