AIAS Cephalon

K252214

Metamorphosis GmbH · cleared 2025-10-07 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“AIAS Cephalon is a fully automated software as a medical device (SaMD)”

Algorithmseveral deep neural networks

source quote (p.6)

“The device uses several deep neural networks that contribute to determining the measurements of anteversion angle, CCD angle, head-element length, tip-apex-distance, and distal locking screw length.”

Adaptive (vs locked)No

source quote (p.7)

“The neural networks used in this device are static and do not evolve over time, i.e., the models are fixed.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

standards: IEC 62304:2015

Retrospective clinical

n=18 patients

endpoints: median error; 95% error quantiles; anteversion angle; CCD angle; head element length; tip-apex-distance; distal locking screw length

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).