Second Opinion CC
K242522Pearl Inc. · cleared 2025-01-16 · product code MYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Second Opinion® CC is a computer aided detection ("CADe") software to aid dentists in the detection of caries by drawing bounding polygons to highlight the suspected region of interest.”
source quote (p.8)
“Utilizes computer vision neural network algorithms, developed from open-source models using supervised machine learning techniques”
source quote (p.9)
“Pearl developed Security controls and processes in accordance with Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff dated September 2023 and Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Drug Administration Staff dated December 2016.”
Validation studies (1)
Reader study (MRMC)
n=500 images
endpoints: efficacy in detecting potential caries lesions; Weighted Alternative Free-Response Receiver Operating Characteristic (wAFROC); HR-ROC-AUC
Reported performance (4 observations)
source quote (p.11)
“Second Opinion CC demonstrated a lesion level sensitivity (95% CI) of 90% (87%, 94%)”
source quote (p.11)
“HR-ROC-AUC, 95% CI was 0.88 (0.85, 0.91).”
source quote (p.11)
“and average false positives per image (95% CI) of 1.34 (1.20, 1.48).”
source quote (p.12)
“The least squares (LS) mean (95% CI) for the Dice coefficient for true positives (n=322) was 0.73 (0.71, 0.75).”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K250525 (decision 2025-11-14) from Pearl, Inc. for a matching device line ("Second Opinion® Panoramic") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K250525
- 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243230 (decision 2025-05-09) from Pearl Inc. for a matching device line ("Second Opinion® BLE") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243230
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K243893 (decision 2025-05-05) from Pearl, Inc. for a matching device line ("Second Opinion® Pediatric") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K243893
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K242600 (decision 2025-04-11) from Pearl Inc. for a matching device line ("Second Opinion Periapical Radiolucency Contours") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K242600
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).