Second Opinion® Panoramic

K250525

Pearl, Inc. · cleared 2025-11-14 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Second Opinion® PR is a radiological automated image processing software device intended to identify and mark regions, in panoramic radiographs, in relation to suspected dental findings which include: caries, periapical radiolucency, and impacted third molars.”
Algorithmneural network-based computer vision algorithms for anatomical and pathological detection
source quote (p.9)
“All devices use neural network-based computer vision algorithms for anatomical and pathological detection.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
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.”

Validation studies (2)

Retrospective clinical

n=795 images

endpoints: weighted alternative free-response receiver operating characteristic (wAFROC) figure of merit (FOM) exceeding the pre-specified performance thresholds for all evaluated dental features

Reader study (MRMC)

n=795 cases

endpoints: statistically significant increases in wAFROC area under the curve (at both a lesion level and image level) for all three evaluated dental features—impacted third molars, periapical radiolucencies, and caries—when readers were aided by SOPR

Reported performance (4 observations)

specificity0.97
source quote (p.14)
“At the surface level, high specificity was maintained (≥0.97) across features, demonstrating minimal over-marking on normal regions.”
sensitivityas written: “Lesion-level sensitivity for impacted third molars”0.99
source quote (p.13)
“Panoramic achieved lesion-level sensitivities of 99%, 82%, and 77% across the three features, indicating strong detection ability even for small or low-contrast lesions.”
sensitivityas written: “Lesion-level sensitivity for periapical radiolucency”0.82
source quote (p.13)
“Panoramic achieved lesion-level sensitivities of 99%, 82%, and 77% across the three features, indicating strong detection ability even for small or low-contrast lesions.”
sensitivityas written: “Lesion-level sensitivity for caries”0.77
source quote (p.13)
“Panoramic achieved lesion-level sensitivities of 99%, 82%, and 77% across the three features, indicating strong detection ability even for small or low-contrast lesions.”

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
0
drift signals on this device

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/K250525