SMART Bun-Yo-Matic X-Ray
K240736Disior Ltd · cleared 2024-07-02 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“SMART Bun-Yo-Matic X-Ray software is to be used by orthopaedic healthcare professionals for diagnosis and surgical planning in a hospital or clinic environment. The medical imaging type intended to be used as the input of the software is X-ray.”
source quote (p.5)
“The device uses machine learning derived outputs.”
Validation studies (1)
Retrospective clinical
n=97 images
endpoints: 95% model conformance within 1.0mm distance to reference model and 2.0 degrees standard deviation for angular measurements; Surgery planning executes mathematical operations for estimated correction ±1 degree for angular measurements and ±1.0 mm for distance measurements; Comparison of the 2D-3D construction to manual measurements as well as ground truth; Comparison of the clinical acceptability of axes placement; Comparison of the planned surgical correction to the actual surgical correction
standards: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
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
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).