Catalog of Regulatory Science Tools to Help Assess New Medical Devices
This regulatory science tool presents a method for assessing credibility of patient-specific computational models implemented in medical device software. Workflow documentation may be accessed here.
Technical Description
The CDRH Guidance document “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Regulatory Submissions” provides a high-level framework for assessing the credibility of computational modeling and simulation. However, there is a need for examples of how to use this guidance document for specific types of models such as patient-specific models (PSMs). PSMs are computational models that have been personalized to a specific patient that can be used to make predictions about that patient. Patient-specific models can be incorporated into medical device software. This tool addresses this gap by providing an example workflow for assessing PSM credibility following the framework outlined in the aforementioned guidance document.
Intended Purpose
This tool complements the CDRH guidance document “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Regulatory Submissions”. The workflow presented in this RST is intended for PSM developers collecting evidence to support PSM credibility to be included in a regulatory submission.
The workflow is applicable to models using first principles governing equations (for example, models based on physics- or physiology-based governing equations). It is not intended to be applicable to data-driven models such as statistical models or machine-learning based models.
The workflow is applicable to patient-specific models implemented in medical device software, such as medical device software tools that receive patient data (for example, imaging data) as input, construct and solve a PSM, and then provide patient-specific predictions to the clinician. The workflow is not applicable to using a virtual cohort of PSMs for in silico performance testing of a medical device. The workflow is not specific to any modeling field or clinical specialty. It is applicable to all device types.
Testing
The workflow was developed based on the findings of Galappaththige et al., “Credibility assessment of patient-specific computational modeling using patient-specific cardiac modeling as an exemplar”, which used a literature review and simulation studies to identify unique considerations for evaluating PSMs and discussed how the standard ASME V&V40-2018: “Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices” could be used for PSMs.
Limitations
The workflow is an example workflow only, intended as a starting point for PSM developers following the FDA guidance document “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Regulatory Submissions”. It is not intended to be a comprehensive framework applicable to all PSMs or all conceivable approaches to PSM credibility assessment. Therefore, the workflow should be adjusted according to the specific details of the model and planned credibility assessment approach.
Supporting Documentation
- Workflow for Assessing the Credibility of PSM
- FDA guidance document “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”
- Galappaththige, S., Gray, R. A., Costa, C. M., Niederer, S., & Pathmanathan, P. (2022). Credibility assessment of patient-specific computational modeling using patient-specific cardiac modeling as an exemplar. PLoS Computational Biology, 18(10), e1010541. https://doi.org/10.1371/journal.pcbi.1010541
- ASME V&V40-2018, “Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices”
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