Second Opinion® Pediatric

K243893

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

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Second Opinion® Pediatric is a computer aided detection ("CADe") software to aid in the detection of caries in bitewing and periapical radiographs.”
Algorithmcomputer vision technology, developed using machine learning techniques; neural network-based computer vision algorithms
source quote (p.5)
“The device utilizes computer vision technology, developed using machine learning techniques, to identify and mark anatomy & pathology in bitewing and periapical radiographs.”
Adaptive (vs locked)No
PCCPNo
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. These processes are used in both the development of Second Opinion® Pediatric and in post-market surveillance to ensure the product upholds the highest standards of privacy and security.”

Validation studies (1)

Retrospective clinical

n=1,182 images

endpoints: Second Opinion® Pediatric sensitivity > 75% for bitewing and periapical images

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

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); 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/K243893