Second Opinion

K210365

Pearl Inc. · cleared 2022-03-04 · product code MYN · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Second Opinion® is a computer aided detection ("CADe”) software device indicated for use by dental health professionals as an aid in their assessment of bitewing and periapical radiographs of permanent teeth in patients 12 years of age or older.”
Algorithmcomputer vision neural network algorithms, developed from open-source models using supervised machine learning techniques
source quote (p.4)
“Second Opinion® employs computer vision technology, developed using machine learning techniques, to detect and draw attention as second reader to regions on bitewing and periapical radiographs where distinct pathologic and/or nonpathologic dental features may appear.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 (3)

Bench

sample size not stated

Standalone

n=2,010 images

endpoints: WAFROC-FOM analysis for primary endpoints; Determination of the changes in sensitivity and change in number of false positive

Reader study (MRMC)

n=2,010 images

endpoints: WAFROC-FOM analysis for primary endpoints; Determination of the changes in sensitivity and change in number of false positive

Reported performance (3 observations)

sensitivity0.8308CI 76.39% – 89.77%
source quote (p.11)
“The standalone sensitivity of the product was in the range of 76.39% – 89.77% and the false positive rate was in the range of 0.46 – 4.85.”
accuracyas written: “Unaided Reader Accuracy (Predicate Device)”0.756
source quote (p.12)
“Unaided Reader Accuracy 0.756 Aided Readers Accuracy 0.883”
accuracyas written: “Aided Readers Accuracy (Predicate Device)”0.883
source quote (p.12)
“Unaided Reader Accuracy 0.756 Aided Readers Accuracy 0.883”

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
7
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

  • …and 1 more.

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/K210365