Videa Perio Assist
K223296VideaHealth, Inc. · cleared 2023-02-06 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“Videa Perio Assist (VPA) software is a cloud-based AI-powered medical device for the automatic measurement of tooth interproximal alveolar bone level in dental radiographs.”
source quote (p.5)
“Videa Perio Assist (VPA) software is a cloud-based AI-powered medical device”
Validation studies (2)
Bench
n=996 images
endpoints: A recall greater than 82%; A precision greater than 82%
Retrospective clinical
n=189 images
endpoints: A sensitivity greater than 82%; A specificity greater than 81%; A mean absolute error less than 1.5mm
Reported performance (2 observations)
source quote (p.9)
“VPA met pre-specified acceptance criteria on bitewing radiographs with a sensitivity of 92.8%, specificity of 89.4% and mean absolute error below the thresholds.”
source quote (p.9)
“VPA met pre-specified acceptance criteria on bitewing radiographs with a sensitivity of 92.8%, specificity of 89.4% and mean absolute error below the thresholds.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).