IB Lab LAMA

K223646

IB Lab GmbH · cleared 2023-06-16 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“IB Lab LAMA is a fully-automated radiological image processing software device intended to aid users in the measurement of limb-length discrepancy and quantitative knee alignment parameters on uni- and bilateral AP full leg radiographs of individuals at least 22 years of age. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is intended to be used by healthcare professionals trained in radiology.”

Algorithmdeep learning technology

source quote (p.5)

“IB Lab LAMA uses deep learning technology to provide precise fully-automated geometric length and angle measurements of the lower limb on full leg X-ray images.”

Adaptive (vs locked)No

source quote (p.5)

“The measurements are compared to fixed predetermined norm-ranges, based on standard state of the art clinical practices hard-coded into the software.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=325 cases

endpoints: agreement; interchangeability; intra-class correlation coefficient (ICC)

Reported performance (2 observations)

sensitivity0.9505CI 90.29%, 98.96%

source quote (p.12)

“Sensitivity 95.05% (90.29%, 98.96%)”

specificity0.998CI 99.39%, 100.00%

source quote (p.12)

“Specificity 99.80% (99.39%, 100.00%)”

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).