Second Opinion® Pediatric

K243893

Pearl, Inc. · cleared 2025-05-05 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“Second Opinion® Pediatric is a radiological, automated, computer- assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs.”

Algorithmneural network-based computer vision algorithms

source quote (p.8)

“Both devices use neural network-based computer vision algorithms for caries lesions display.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.9)

“Pearl developed Security controls and processes in accordance with FDA Guidance - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions dated September 2023.”

Validation studies (1)

Retrospective clinical

n=1,182 images

endpoints: lesion level sensitivity for caries detection; FPPI; wAFROC FOM; HR-ROC FOM; LS mean Dice Score

Reported performance (2 observations)

sensitivity0.87CI 0.84, 0.90

source quote (p.10)

“The z-score analysis of the lesion level sensitivity for caries detection showed the estimated lesion level sensitivity (95% CI) was 0.87 (0.84, 0.90).”

diceas written: “LS mean Dice Score”0.76CI 0.75, 0.77

source quote (p.10)

“the LS mean Dice Score (95% CI) was 0.76 (0.75, 0.77)”

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

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).