Second Opinion® BLE

K243230

Pearl Inc. · cleared 2025-05-09 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“Second Opinion® BLE is a radiological automated image processing software device intended to identify and display bone level measurements in bitewing and periapical radiographs. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is designed to aid dental health professionals to review bitewing and periapical radiographs of permanent teeth in patients 12 years of age or older as a concurrent and second reader.”

Algorithmmachine learning, computer vision neural network algorithms

source quote (p.6)

“Second Opinion BLE uses machine learning to detect bone level measurements. Images received by the ML modules are processed yielding detections which are represented as metadata. The final output is made accessible to the API for the purpose of sending to the UI for visualization. Detected bone level measurements are displayed as linear overlays atop the original radiograph which indicate to the practitioner which regions contain which detected potential conditions that may require clinical review. The clinician can toggle over the image to highlight a potential condition for viewing.”

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)

Retrospective clinical

n=396 patients

endpoints: precision and recall for bitewing and periapical images; mean absolute difference in bitewing and periapical images

Reported performance (4 observations)

ppvas written: “Precision (Bitewing)”0.87CI 95% CI: 86%, 88%

source quote (p.11)

“Second Opinion BLE demonstrated an 87% (95% CI: 86%, 88%) precision and 91% (95% CI: 90%, 92%) recall in bitewing images.”

sensitivityas written: “Recall (Bitewing)”0.91CI 95% CI: 90%, 92%

source quote (p.11)

“Second Opinion BLE demonstrated an 87% (95% CI: 86%, 88%) precision and 91% (95% CI: 90%, 92%) recall in bitewing images.”

ppvas written: “Precision (Periapical)”0.87CI 95% CI: 85%, 89%

source quote (p.11)

“Second Opinion BLE demonstrated an 87% (95% CI: 85%, 89%) precision value and 87% (95% CI: 85%, 89%) recall value for measurement of interproximal bone levels in periapical images”

sensitivityas written: “Recall (Periapical)”0.87CI 95% CI: 85%, 89%

source quote (p.11)

“Second Opinion BLE demonstrated an 87% (95% CI: 85%, 89%) precision value and 87% (95% CI: 85%, 89%) recall value for measurement of interproximal bone levels in periapical images”

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

—

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) 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). 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).