Second Opinion® CS

K243234

Pearl Inc. · cleared 2025-06-12 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Second Opinion® CS is a computer aided detection ("CADe”) software to aid in the detection and segmentation of caries in periapical radiographs. The device is a software-only device”
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 (2)

Retrospective clinical

n=1,250 images

endpoints: sensitivity

Reader study (MRMC)

n=330 images

endpoints: wAFROC-FOM difference; lesion-level sensitivity; false positives per image (FPPI); surface-level specificity; localization and segmentation accuracy (Jaccard index)

Reported performance (3 observations)

sensitivity0.88CI 95% CI
source quote (p.10)
“The z-score analysis of the lesion level sensitivity for overall caries detection by image type showed the estimated lesion level sensitivity (95% CI) was 0.88.”
sensitivityas written: “lesion-level sensitivity increase (aided vs unaided)”0.2CI 0.16-0.24
source quote (p.11)
“Secondary endpoints revealed a significant increase in lesion-level sensitivity (0.20, 95% CI: 0.16-0.24).”
specificityas written: “surface-level specificity decrease (aided vs unaided)”-0.02CI -0.04–0.00
source quote (p.11)
“Surface-level specificity decreased marginally (-0.02, 95% CI: -0.04–0.00).”

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
1
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

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/K243234