Table 2.
Evidence categories from Table 1 that are most relevant for establishing the credibility of the various ISCT submodels and the full ISCT.
| ISCT submodel | Credibility evidence category* | |||||||
|---|---|---|---|---|---|---|---|---|
| Code verification ①† | Model calibration ② | Bench test validation ③ | In vivo validation ④ | Population-based validation ⑤ | Emergent model behavior ⑥ |
Model plausibility ⑦ | Calc. Ver./UQ using COU simulations ⑧ |
|
| Device model | ||||||||
| Patient model | ||||||||
| Coupled device-patient model | ||||||||
| Virtual patient cohort model | ||||||||
| Clinician model | ||||||||
| Clinical outcome mapping model | ||||||||
| Full ISCT | ||||||||
*This table does not imply that all of the listed activities should be performed to establish ISCT credibility. The specific activities that are needed to demonstrate credibility will generally depend on the model risk assessment.†Code verification includes both software quality assurance (SQA) and numerical code verification (NCV) (22). Dark gray indicates both SQA and NCV are applicable. Light gray indicates only SQA applies.