Second Opinion

K210365

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

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.9)

“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.7)

“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)

Standalone

n=2,010 images

endpoints: pathological (Caries, discrepancy at the margin, calculus, and periapical radiolucency) and non-pathologic feature detection performance (Crowns, fillings, rootcanal, bridges, and Implants)

Reader study (MRMC)

n=2,010 images

endpoints: detection accuracy of readers aided by Second Opinion® is superior to the detection accuracy of readers unaided by Second Opinion®

Reported performance (2 observations)

sensitivityas written: “Standalone Sensitivity Range”stated without valueCI 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.”

sensitivityas written: “Improvement in Sensitivity (single dental finding)”stated without valueCI 0.9%-11.7%

source quote (p.11)

“Moreover, the improvement in sensitivity of a single dental finding was in the range of 0.9%-11.7% and examination of the individual improvement in sensitivity documented that:”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

-100%

vs code's own 3-yr baseline

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). 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).