Second Opinion Periapical Radiolucency Contours

K242600

Pearl Inc. · cleared 2025-04-11 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Second Opinion PC (Periapical Radiolucency Contouring) is a radiological, automated, computer-assisted detection (CADe) software intended to aid in the detection of periapical radiolucencies on periapical radiographs using polygonal contours. The device is not intended as a replacement for a complete dentist's review or their clinical judgment which considers other relevant information from the image, patient history, or actual in vivo clinical assessment.”
Algorithmcomputer vision neural network algorithms, developed from open-source models using supervised machine learning techniques
source quote (p.8)
“Utilizes computer vision neural network algorithms, developed from open-source models using supervised machine learning techniques”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Retrospective clinical

n=500 images

endpoints: non-inferiority in periapical radiolucency detection accuracy; wAFROC-FOM; HR-ROC-AUC; lesion level sensitivity; average false positives per image

Standalone

sample size not stated

endpoints: wAFROC-FOM; HR-AUC

Standalone

n=763 images

endpoints: Overall standalone sensitivity; Image Level Standalone Sensitivity; Image Level Standalone Specificity

Reported performance (13 observations)

sensitivity0.77CI 69%, 84%
source quote (p.11)
“Second Opinion PC demonstrated a lesion level sensitivity (95% CI) of 77% (69%, 84%)”
aurocas written: “auc”0.93CI 0.90, 0.96
source quote (p.11)
“HR-ROC-AUC, 95% Cl was 0.93 (0.90, 0.96).”
false_positive_rate_per_imageas written: “average false positives per image”0.28CI 0.23, 0.33
source quote (p.11)
“and average false positives per image (95% CI) of 0.28 (0.23, 0.33).”
sensitivityas written: “Overall standalone sensitivity”0.88CI 84.7%, 91.4%
source quote (p.12)
“Overall standalone sensitivity was 88% (84.7%, 91.4%).”
sensitivityas written: “Dexis - Sensitivity”0.867CI 0.800, 0.933
source quote (p.12)
“Dexis - Sensitivity: 0.867 (0.800, 0.933)”
specificityas written: “Dexis - Specificity”0.885CI 0.827, 0.942
source quote (p.12)
“Specificity: 0.885 (0.827, 0.942)”
sensitivityas written: “E2v - Sensitivity”0.861CI 0.785, 0.937
source quote (p.12)
“E2v - Sensitivity: 0.861 (0.785, 0.937)”
specificityas written: “E2v - Specificity”0.804CI 0.728, 0.875
source quote (p.12)
“Specificity: 0.804 (0.728, 0.875)”
sensitivityas written: “Gendex - Sensitivity”0.889CI 0.815, 0.951
source quote (p.12)
“Gendex - Sensitivity: 0.889 (0.815, 0.951)”
specificityas written: “Gendex - Specificity”0.793CI 0.712, 0.865
source quote (p.12)
“Specificity: 0.793 (0.712, 0.865)”
sensitivityas written: “Schick - Sensitivity”0.908CI 0.836, 0.961
source quote (p.12)
“Schick - Sensitivity: 0.908 (0.836, 0.961)”
specificityas written: “Schick - Specificity”0.891CI 0.827, 0.945
source quote (p.12)
“Specificity: 0.891 (0.827, 0.945)”
aurocas written: “HR-AUC”stated without valueCI 0.82, 0.89
source quote (p.12)
“The device exhibited equivalent standalone HR-AUC performance for both Jaccard Indexes of 0.4 and 0.5 with 95% Cls of (0.82, 0.89) for PRs.”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
-100%
vs code's own 3-yr baseline
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243234 (decision 2025-06-12) from Pearl Inc. for a matching device line ("Second Opinion® CS") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243234

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243989 (decision 2025-05-23) from Pearl, Inc. for a matching device line ("Second Opinion® 3D") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243989

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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K242600