根据ASME V&V40计算模型的可信度评估:应用于博洛尼亚生物机械计算机断层扫描解决方案
Alessandra Aldieri1, Cristina Curreli2, Julia Aleksandra Szyszko2
1PolitoBIOMedLab, Department of Mechanical and Aerospace Engineering, Politecnico di Torino, Italy; Medical Technology Lab, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Computer methods and programs in biomedicine
|July 31, 2023
概括
博洛尼亚生物机械计算机断层扫描 (BBCT) 模型
科学领域:
- 生物机械工程 生物机械工程
- 计算建模计算建模
- 监管科学是一种监管科学.
背景情况:
- 计算模型需要证明监管和临床使用的预测准确性.
- ASME V&V40-2018提供了一个基于风险的框架,用于评估计算模型的可信性.
- 越来越多地考虑使用in silico方法来为医学中的监管决策提供信息.
研究的目的:
- 将ASME V&V40-2018可信度框架应用于博洛尼亚生物机械计算机断层扫描 (BBCT) 解决方案.
- 评估BBCT模型对预测绝对骨骨折风险的可信度.
- 为了证明基于风险的可信度评估对监管提交的实际实施.
主要方法:
- 在BBCT模型上全面实施ASME V&V40-2018框架.
- 定义 BBCT 模型的使用上下文.
- 执行信誉活动:验证,验证和适用性.
- 确定所取得的可信度水平.
主要成果:
- BBCT模型的风险被评为中等.
- 对BBCT模型的可信度水平被认为是可以接受的.
- 在物质财产分配的不确定性被确定为影响BBCT预测的主要因素.
结论:
- 该研究成功地应用了ASME V&V40-2018基于风险的可信度评估框架.
- 该框架可用于在各个领域建立模型可信度.
- 该应用程序支持未来的监管提交,并促进采用in-silico试验.
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