Published December 27, 2023 | Version v1
Project deliverable Open

SIMCor. Deliverable 4.6 - SOPs for validation of in silico models (BIO, IIB, CHA, M36)

  • 1. ROR icon Biotronik (Germany)
  • 2. ROR icon Institute for ImplantTechnology and Biomaterials
  • 3. Charité - Universitätsmedizin Berlin
  • 4. Charité Universitätsmedizin Berlin

Description

This SOP guides on how to apply the ASME V&V 40 standard for in-silico model validation, with examples of the clinical endpoints device perforation, device migration, thrombosis for the pulmonary artery pressure sensor as well as thrombosis, paravalvular leakage and durability for the transcatheter aortic valve. Emphasis is placed on the application of a tiered validation approach of the in-silico models, consisting of a low-fidelity validation to gain trust in the engineering metrics output in bench tests, ex-vivo experiments and acute animal trials, as well as high-fidelity validation steps in chronic animal trials and (retrospective) clinical trials supported by tests in virtual cohorts. The results are subjected to an applicability analysis. The validation and applicability assessment steps are derived from the applicable standards, extended where necessary, and applied to the specific use cases. Detailed examples for both use cases can be found in the two appendices.

 

SIMCor (In-Silico testing and validation of Cardiovascular IMplantable devices) has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 101017578.

Files

SIMCor_D4.6_SOPs for validation of in-silico models_BIO_27-12-2023_signed.pdf

Additional details

Funding

SIMCOR – In Silico testing and validation of Cardiovascular Implantable devices 101017578
European Commission

Dates

Accepted
2023-12-27