Clinical Evidence
Skinpendium is investigational, not FDA-cleared. Its clinical performance will be established in validation studies designed around the FDA special controls for this device type and reported with the regulatory submission.
How we evaluate
Confirmed reference standard
Lesions are scored against confirmed diagnoses (histopathology or dermatologic consensus), not a single clinician's impression.
Tested on new institutions
Performance is measured on images from clinics and image sources the model never saw in training, because generalization to new sites is the point.
Held to the special controls
Melanoma sensitivity is the special control for this device type (21 CFR 878.1830). Every model candidate is evaluated against it.
Pre-registered, one change at a time
Each experiment is registered before it runs and changes a single thing, so any improvement can be attributed to it.
Calibrated probabilities
Reported probabilities are calibrated so that a stated risk behaves like that risk.
Disclaimer: Skinpendium is an investigational device that has not been cleared by the FDA for commercial distribution. This page describes how the device is being evaluated. It makes no claims about its performance.