Second Opinion Periapical Radiolucency Contours

K242600

Pearl Inc. · cleared 2025-04-11 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Second Opinion PC is a computer aided detection ("CADe”) software to aid dentists in the detection of periapical radiolucencies by drawing bounding polygons to highlight the suspected region of interest. It is designed to aid dental health professionals to review periapical radiographs of permanent teeth in patients 12 years of age or older as a second reader. The device is a software-only device, so most testable characteristics common to other device types, including Biocompatibility/Materials, Shelf Life/Sterility, Electromagnetic Compatibility and Electrical Safety, Magnetic Resonance (MR) Compatibility, are not applicable to this device.”
Algorithmcomputer vision neural network algorithms, developed from open-source models using supervised machine learning techniques
source quote (p.5)
“The device utilizes computer vision technology, developed using machine learning techniques, to identify and mark potential periapical radiolucencies with bounding boxes. Second Opinion PC uses machine learning to detect periapical radiolucencies. All devices use neural network-based computer vision algorithms for periapical radiolucencies detection.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Standalone

n=500 images

endpoints: periapical radiolucency detection accuracy; wAFROC-FOM; HR-ROC-AUC

Reported performance (4 observations)

sensitivity0.77CI 69%, 84%
source quote (p.11)
“Second Opinion PC demonstrated a lesion level sensitivity (95% CI) of 77% (69%, 84%)”
aurocas written: “auc”0.85CI 0.81, 0.89
source quote (p.11)
“The wAFROC-FOM, 95% CI for Second Opinion PC was 0.85 (0.81, 0.89)”
aurocas written: “HR-ROC-AUC”0.93CI 0.90, 0.96
source quote (p.11)
“HR-ROC-AUC, 95% CI was 0.93 (0.90, 0.96).”
false_positive_rate_per_imageas written: “average false positives per image”0.28CI 0.23, 0.33
source quote (p.11)
“and average false positives per image (95% CI) of 0.28 (0.23, 0.33).”

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/K242600