U.S. flag An official website of the United States government

U.S. Food and Drug Administration

Credibility Assessment Planning Tool for Model-Based Pulmonary Artery Reconstruction

Catalog of Regulatory Science Tools to Help Assess New Medical Devices 

This regulatory science tool (RST) provides an applied credibility assessment plan for a computational model-based, patient-specific surgical planning workflow that predicts optimal patch shape in branch pulmonary artery reconstruction.

Technical Description

This RST is an applied credibility assessment plan that accompanies a patient-specific computational solid mechanics model used to predict optimal patch shape for congenital branch pulmonary artery reconstruction surgery. This tool applies a step-by-step credibility assessment process for evaluating the adequacy of patient-specific surgical planning computational model of pulmonary artery reconstruction. The model's function is to predict an optimal patch shape for use in congenital branch pulmonary artery reconstruction surgery.

The tool's user manual includes a credibility assessment that was performed on the model. This credibility assessment describes the question of interest, model context of use, risk assessment, and the verification, validation, and uncertainty quantification (VVUQ) activities performed. Credibility factors were assessed, and an adequacy assessment was also performed. 

Intended Purpose 

This RST is intended for use by computational modeling practitioners as a reference example of a documented credibility assessment for a patient-specific solid-mechanics model in a congenital cardiac surgery context. The workflow and its associated credibility documentation are provided to serve as a well-documented instance of a patient-specific computational model for a specific clinical use. Intended users include medical device developers and computational modeling practitioners, and FDA reviewers, with familiarity with credibility assessment frameworks such as ASME V&V 40-2018. This RST is particularly relevant to submissions involving patient-specific computational solid mechanics models used in cardiovascular applications. Device developers and modeling practitioners working with other patient-specific modeling workflows may also find the RST useful.

Testing

Since this RST is a reference example of a credibility assessment plan rather than a computational tool, peer review of the associated publication serves as an appropriate test of the documentation's rigor. The underlying patient-specific surgical planning workflow and its associated VVUQ activities are documented in the peer-reviewed publication S. Kizilski et al., Preclinical Validation of a Patient-Specific Patch-Planning Workflow for Congenital Cardiovascular Reconstruction, Annals of Biomedical Engineering, 2025.

Limitations

  • This RST was developed for the specific application of predicting patch shape in branch pulmonary artery reconstruction using solid mechanics. It has not been validated for other anatomical locations, surgical procedures, or physics (e.g., fluid dynamics).
  • The risk assessment performed as part of the model's credibility evaluation is specific to its intended use and may not be comprehensive for other applications.

Supporting Documentation

The credibility assessment is provided in the Supplemental Material of

  • S. Kizilski et al., Preclinical Validation of a Patient-Specific Patch-Planning Workflow for Congenital Cardiovascular Reconstruction, Annals of Biomedical Engineering, 53(12):3505-3522, 2025. Available at https://doi.org/10.1007/s10439-025-03870-4

For a direct link to the supplemental material, click here. The supplementary material to Kizilski et al. (2025) serves as the user manual for this RST, containing the credibility assessment documentation including the context of use, risk assessment, and VVUQ activities.

Contact

Tool Reference