Second Opinion CC

K242522

Pearl Inc. · cleared 2025-01-16 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
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
PCCPNo
Cybersecurity addressedYes
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 Food and Drug Administration Staff dated December 2016. These processes are used in both the development of Second Opinion CC and in post-market surveillance to ensure the product upholds the highest standards of privacy and security.”

Validation studies (1)

Standalone

n=500 images

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

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" issued on 03, Jul 2012

Reported performance (4 observations)

sensitivity0.9CI 87%, 94%
source quote (p.11)
“Second Opinion CC demonstrated a lesion level sensitivity (95% CI) of 90% (87%, 94%)”
aurocas written: “auc”0.88CI 0.85, 0.91
source quote (p.11)
“HR-ROC-AUC, 95% CI was 0.88 (0.85, 0.91).”
false_positive_rate_per_imageas written: “average false positives per image”1.34CI 1.20, 1.48
source quote (p.11)
“average false positives per image (95% CI) of 1.34 (1.20, 1.48).”
diceas written: “Dice coefficient for true positives”0.73CI 0.71, 0.75
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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
-100%
vs code's own 3-yr baseline
6
drift signals on this device
  • 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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K242522