Second Opinion® BLE

K243230

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

FDA 510(k) summary for Second Opinion® BLE (K243230)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
4
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Second Opinion® BLE is a radiological automated image processing software device intended to identify and display bone level measurements in bitewing and periapical radiographs.”
Algorithmmachine learning, neural network-based computer vision 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”
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; recall; mean absolute difference

Reported performance (4 observations)

sensitivity0.91CI 90%, 92%
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 and a 87% (95% CI: 86%, 88%) precision and 91% (95% CI: 90%, 92%) recall in bitewing images.”
ppvas written: “Precision (Bitewing)”0.87CI 86%, 88%
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 and a 87% (95% CI: 86%, 88%) precision and 91% (95% CI: 90%, 92%) recall in bitewing images.”
ppvas written: “Precision (Periapical)”0.87CI 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 and a 87% (95% CI: 86%, 88%) precision and 91% (95% CI: 90%, 92%) recall in bitewing images.”
sensitivityas written: “Recall (Periapical)”0.87CI 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 and a 87% (95% CI: 86%, 88%) precision and 91% (95% CI: 90%, 92%) recall in bitewing 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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
3
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_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 2026-08-26.

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.

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243230