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) that provides image analysis features and intraoperative instructions for proximal femur fracture surgery supporting the positioning of the Depuy Synthes TFN-ADVANCED Proximal femoral nail (TFNA) implant.”
Algorithmdeep 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.”
PCCPNo
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

standards: IEC 62304:2015

Bench

n=11,000 images

endpoints: median error; 95% error quantiles of the measurements provided by the device (anteversion angle, CCD angle, head element length, tip-apex-distance, and distal locking screw length)

Bench

sample size not stated

endpoints: safe and effective use under realistic use conditions; unintended performance of the fully automated imaging software across the variety of expected use cases is unlikely

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

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 2026-07-08.

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).

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252214