Overjet Calculus Assist

K220928

Overjet Inc. · cleared 2022-12-16 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Overjet Calculus Assist is a module within the Overjet Platform. The Overjet Calculus Assist (OCalA) software automatically detects interproximal calculus on bitewing and periapical radiographs.”

AlgorithmThe decision layer processes the image to ensure it is the correct data type, and then annotates it via the algorithm

source quote (p.6)

“The decision layer processes the image to ensure it is the correct data type, and then annotates it via the algorithm”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Standalone

n=9,716 other

endpoints: Sensitivity; Specificity; AUC

standards: FDA's "Guidance for Industry and Food and Drug Administration Staff Computer-assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Notification [510(k)] Submissions Document"

Reader study (MRMC)

n=614 images

endpoints: sensitivity; specificity; alternative free response receiver operating characteristic (AFROC)

Reported performance (9 observations)

sensitivity74.1CI 66.2%, 82.0%

source quote (p.7)

“Overall standalone sensitivity was 74.1% (66.2%, 82.0%) for bitewing radiographs, and 72.9% (65.3%, 80.5%) for periapical radiographs.”

specificity99.4CI 99.1%, 99.6%

source quote (p.7)

“Overall standalone specificity was 99.4% (99.1%, 99.6%) for bitewing radiographs, and 99.6% (99.3%, 99.8%) for periapical radiographs.”

aurocas written: “auc”0.859CI 0.823, 0.894

source quote (p.8)

“Image Type Bitewing AUC 0.859 95% CI1 0.823, 0.894 Periapical 0.867 0.828, 0.903”

sensitivityas written: “Assisted Sensitivity (Bitewing)”84CI 78.8%, 88.2%

source quote (p.8)

“For bitewing radiographs, overall reader sensitivity improved from 74.9% (68.3%, 80.2%) to 84.0% (78.8%, 88.2%) unassisted vs assisted.”

sensitivityas written: “Assisted Sensitivity (Periapical)”84.4CI 78.8%, 89.2%

source quote (p.8)

“For periapical radiographs, overall reader sensitivity improved from 74.7% (69.9%, 79.0%) to 84.4% (78.8%, 89.2%) unassisted vs assisted.”

specificityas written: “Assisted Specificity (Bitewing)”98.6CI 98.4%, 98.9%

source quote (p.8)

“For bitewing radiographs, overall reader specificity decreased slightly from 98.8% (98.7%, 99.0%) to 98.6% (98.4%, 98.9%) unassisted vs assisted.”

specificityas written: “Assisted Specificity (Periapical)”98CI 97.7%, 98.4%

source quote (p.9)

“For periapical radiographs, overall reader specificity also decreased slightly from 98.1% (97.8%, 98.4%) to 98.0% (97.7%, 98.4%) unassisted vs assisted.”

aurocas written: “Assisted AUC (Bitewing)”0.878CI 0.844, 0.913

source quote (p.9)

“For the average of all readers, AUC increased from 0.840 (0.800, 0.880) to 0.878 (0.844, 0.913) on bitewing radiographs, and from 0.846 (0.808, 0.884) to 0.900 (0.870, 0.929) on periapical radiographs.”

aurocas written: “Assisted AUC (Periapical)”0.9CI 0.870, 0.929

source quote (p.9)

“For the average of all readers, AUC increased from 0.840 (0.800, 0.880) to 0.878 (0.844, 0.913) on bitewing radiographs, and from 0.846 (0.808, 0.884) to 0.900 (0.870, 0.929) on periapical radiographs.”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

-100%

vs code's own 3-yr baseline

drift signals on this device

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).