Spine CAMP (1.1)

K231668

Medical Metrics, Inc. · cleared 2023-07-07 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain static and/or motion metrics.”

AlgorithmAI Engine with AI models, updated by retraining with more imaging for improved generalization and performance, and logic improvements to address potential failure modes.

source quote (p.5)

“Spine CAMP's primary component, the AI Engine, was updated by retraining its AI models with more imaging for improved generalization and performance. Improvements were also made to the AI Engine's logic to address potential failure modes.”

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)

Bench

n=447 images

endpoints: functionality of the device across multiple datasets; performance qualification (PQ) tests; correlation and statistical equivalence for all variables evaluated

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

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).