SMART PCFD
K250023Disior Ltd · cleared 2025-09-29 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.4)
“SMART PCFD software includes AI-powered algorithms and is intended to be used to support orthopedic healthcare professionals in the diagnosis and surgical planning of Progressive Collapsing Foot Deformity (PCFD) in a hospital or clinic environment. The medical image modality intended to be used in the software is weight-bearing CT (WBCT).”
AlgorithmAI-powered algorithms, machine learning derived outputs
source quote (p.4)
“SMART PCFD software includes AI-powered algorithms and is intended to be used to support orthopedic healthcare professionals in the diagnosis and surgical planning of Progressive Collapsing Foot Deformity (PCFD) in a hospital or clinic environment. The medical image modality intended to be used in the software is weight-bearing CT (WBCT). The device includes the same machine learning derived outputs as the primary predicate SMART Bun-Yo-Matic CT (K240642) device and no new validations were conducted.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this
Validation studies (2)
Retrospective clinical
n=82 images
Bench
sample size not stated
endpoints: estimated correction +1 degree for angular measurements; ±1.0 mm for distance measurements
Reported performance (2 observations)
sensitivity100
source quote (p.6)
“The existence of metal was identified correctly for 98.8% of the images (specificity 98%, sensitivity 100%).”
specificity98
source quote (p.6)
“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
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).