Overjet Caries Assist-Pediatric
K233738Overjet, Inc · cleared 2024-03-04 · product code MYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“OCA-Ped is a software-only device which operates in three layers: a Network Layer, a Presentation Layer, and a Decision Layer.”
source quote (p.4)
“Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Layer and results are pushed to the dashboard, which are in the Presentation Layer.”
Validation studies (2)
Reader study (MRMC)
n=636 cases
endpoints: AUC of the WAFROC
standards: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions, Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions
Standalone
n=1,190 images
endpoints: Tooth level standalone sensitivity; Tooth Level standalone specificity; Standalone Dice
standards: Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions, Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions
Reported performance (8 observations)
source quote (p.6)
“Tooth level standalone sensitivity was 83.9%, 95% CI's (0.816, 0.860).”
source quote (p.6)
“Tooth Level standalone specificity was 97.5%, 95% CI's (0.971, 0.979).”
source quote (p.6)
“Standalone Dice was a mean of 79.0%, 95% CI's (0.784, 0.797).”
source quote (p.6)
“Carestream 0.870 (0.832, 0.900)”
source quote (p.6)
“Dexis 0.872 (0.841, 0.902)”
source quote (p.6)
“E2V 0.761 (0.713, 0.806)”
source quote (p.6)
“Gendex 0.843 (0.800, 0.882)”
source quote (p.6)
“Schick 0.844 (0.805, 0.878)”
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).