TraumaCad Neo (1.1)
K243810Brainlab Ltd. · cleared 2025-06-04 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“The software is not intended for primary radiological image interpretation or radiological appraisal.”
AlgorithmAI/ML based algorithm
source quote (p.10)
“The automatic postoperative total hip arthroplasty analysis is achieved by the AI/ML based algorithm, by automatically identifying whether a relevant implant is present, and as a next step, if an implant is found, detecting certain landmarks on patient's anatomy and on the implant on the DICOM image.”
Adaptive (vs locked)No
source quote (p.10)
“The mentioned AI/ML models are non-adaptive, i.e. do not learn from data once initially trained.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (1)
Retrospective clinical
n=349 images
endpoints: Accuracy of implant presence; 2D landmark detection; distance to ground-truth landmark annotation
Reported performance (2 observations)
accuracyas written: “Implant presence detection accuracy”0.99
source quote (p.11)
“The results showed that 99% of the time the machine learning algorithm was able to correctly determine the implant presence”
accuracyas written: “Landmark detection accuracy (within 4mm distance)”0.92
source quote (p.11)
“and 92% of the landmarks were successfully detected automatically within 4mm distance from their corresponding ground-truth landmark annotations.”
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). 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).