SMART Bun-Yo-Matic CT

K240642

Disior Ltd · cleared 2024-06-20 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The SMART Bun-Yo-Matic CT device is an automatic software tool that segments foot and ankle bones from computed tomography (CT) images and provides a case report showing images of a 3D model of the segmented structures with pre-operative and post-correction measurements. The device includes machine learning derived outputs.”
Algorithmmachine learning algorithm
source quote (p.6)
“The SMART Bun-Yo-Matic CT software machine learning algorithm training and tuning data used during the algorithm development, as well as test data used in the standalone software performance assessment study, were all independent data sets.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Retrospective clinical

n=82 images

endpoints: correctly identified bones of foot and ankle; correctly identified metal

Bench

sample size not stated

endpoints: 95% model conformance within 1.0mm distance to reference model; 2.0 degrees standard deviation for angular measurements; estimated correction +/-1 degree for angular measurements; estimated correction +/-1.0 mm for distance measurements

Reported performance (2 observations)

sensitivity100
source quote (p.5)
“The existence of metal was identified correctly for 98.8% of the images (specificity 98%, sensitivity 100%).”
specificity98
source quote (p.5)
“The existence of metal was identified correctly for 98.8% of the images (specificity 98%, sensitivity 100%).”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K240736 (decision 2024-07-02) from Disior Ltd for a matching device line ("SMART Bun-Yo-Matic X-Ray") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K240736

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/K240642