EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
K234042Ever Fortune.AI Co., Ltd. · cleared 2024-06-07 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“The device is a software designed to aid the quantification of bone age for patients between 2 to 16 years old. The software uses deep learning techniques to analyze posterior-anterior (PA) radiographs of the left-hand according to the Greulich-Pyle (GP) method.”
source quote (p.5)
“The software uses deep learning techniques to analyze posterior-anterior (PA) radiographs of the left-hand according to the Greulich-Pyle (GP) method.”
source quote (p.7)
“Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.”
Validation studies (2)
Retrospective clinical
n=600 cases · 27 site(s)
endpoints: intercept and slope of a Deming regression between GT and EFAI BAPXR's output
standards: IEC 62304:2006/A1:2016, ISO 14971:2019
Reader study (MRMC)
n=600 cases · 27 site(s)
endpoints: intercept and slope of a Deming regression between GT and EFAI BAPXR's output
standards: IEC 62304:2006/A1:2016, ISO 14971:2019
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).