Toward trustworthy medical device in silico clinical trials: a hierarchical framework for establishing credibility and strategies for overcoming key challenges

HIGHLIGHTS

• What: The aim of this study is to begin addressing some of these challenges and to identify general strategies for establishing the credibility of an ISCT. The approach that is used to represent anatomical geometry should also be described, including whether the geometry is patient-specific, parametric, or otherwise generated. That is, given a single virtual patient and a set of device instructions for use, multiple clinicians could be consulted to inform virtual treatments and the varied responses considered separately, or the model could automatically predict multiple treatment approaches that a clinician would reasonably follow (e_g, device . . .
  

   

  

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