OsteoSight Hip (v1)
K251408Naitive Technologies Ltd · cleared 2025-09-02 · product code SAO · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“OsteoSight is an AI-enabled software as a Medical Device (SaMD)”
source quote (p.10)
“Supervised Machine Learning (ML)”
source quote (p.9)
“OsteoSight can be installed in the cloud, via a host integration platform, which may be within the existing secured network of a clinical site.”
Validation studies (1)
Retrospective clinical
n=3,082 patients · 6 site(s)
endpoints: compare sensitivity and specificity of the device with the accepted gold standard, Dual-Energy X-ray Absorptiometry (DXA), with pre-specified performance goals.
standards: ISO 14971, BS EN 62366, IEC 62304
Reported performance (5 observations)
source quote (p.15)
“sensitivity was 0.370 (95% CI 0.349-0.391)”
source quote (p.15)
“specificity was 0.951 (95% CI 0.936-0.963)”
source quote (p.15)
“Among patients in whom a result was generated, the area under the ROC curve (AUC) was 0.837 (95% CI 0.821-0.852).”
source quote (p.15)
“Sensitivity for detecting low BMD was 0.441 (95% CI 0.386-0.487)”
source quote (p.15)
“specificity was 0.943 (95% CI 0.922-0.961)”
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).