Videa Caries Assist
K213795VideaHealth, Inc · cleared 2022-04-21 · product code MYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.7)
“The subject device is a software-only device.”
source quote (p.6)
“Supervised Deep Learning”
Validation studies (2)
Standalone
n=1,034 images · 10 site(s)
endpoints: Overall average Alternative Free-response Receiver Operating Characteristic Figure of Merit (AFROC FOM); average image-based Sensitivity; average image-based PPV; average lesion-based Sensitivity; average lesion-based PPV
Reader study (MRMC)
n=226 images · 10 site(s)
endpoints: determine whether the diagnostic accuracy of readers aided by VCA is superior to reader accuracy when unaided by VCA, as determined by the AFROC Figure of Merit (AFROC FOM)
Reported performance (4 observations)
source quote (p.7)
“Overall average Se - image-based (%) 70.8 (68.0, 73.7)”
source quote (p.7)
“Overall average FOM 0.740 (0.721, 0.760)”
source quote (p.7)
“Overall average PPV - image-based (%) 59.5 (56.5, 62.5)”
source quote (p.7)
“Overall average PPV (%) - lesion-based (pooled) 64.9 (62.3, 67.6)”
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).