Spine CAMP
K221632Medical Metrics, Inc. · cleared 2022-10-18 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Spine CAMP™ is a fully-automated image processing software device.”
source quote (p.5)
“Spine CAMP™ employs non-adaptive machine learning algorithms that were trained from data generated by the predicate device to automate the radiological image processing and analysis.”
source quote (p.5)
“Spine CAMP™ employs non-adaptive machine learning algorithms that were trained from data generated by the predicate device to automate the radiological image processing and analysis.”
Validation studies (2)
Bench
sample size not stated
endpoints: functionality of the device
Bench
n=447 images
endpoints: Statistical correlations and equivalence tests for vertebral landmark coordinates, image calibration, and radiographic metrics
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K231668 (decision 2023-07-07) from Medical Metrics, Inc. for a matching device line ("Spine CAMP (1.1)") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K231668
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).