BoneView
K222176Gleamer · cleared 2023-03-02 · product code QBS · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.5)
“BoneView 1.1-US is a software-only device intended to assist clinicians in the interpretation of: limbs radiographs of children/adolescents and limbs, pelvis, rib cage, and dorsolumbar vertebra radiographs of adults.”
AlgorithmSupervised Deep Learning
source quote (p.9)
“Machine Learning Methodology Supervised Deep Learning”
Adaptive (vs locked)No
source quote (p.6)
“These two operating points are implemented in the User Interface as follow: Dotted-line Bounding Box: suspicious area / subtle fracture (when the level of confidence of the AI algorithm associated with the finding is above “high-sensitivity operating point" and below “high-specificity operating point") displayed as a dotted bounding box around the area of interest Solid-line Bounding Box: definite or unequivocal fractures (when the level of confidence of the AI algorithm associated with the finding is above “high-specificity operating point") displayed as a solid bounding box around the area of interest”
PCCPFDA source did not state this
Cybersecurity addressedNo
Validation studies (3)
Standalone
n=2,000 images
endpoints: Sensitivity; Specificity
Standalone
n=8,918 images
endpoints: Sensitivity; Specificity
Retrospective clinical
n=480 cases
endpoints: diagnostic accuracy of readers aided by BoneView is superior to the diagnostic accuracy of readers unaided by BoneView as determined by the Specificity/Sensitivity pair (primary endpoint)
Reported performance (8 observations)
sensitivity0.909CI 0.889 - 0.926
source quote (p.12)
“Sensitivity (with 95% Clopper-Pearson CI) and Specificity (with 95% Clopper-Pearson CI) of BoneView at the examination-level at the high-sensitivity operating point and high-specificity operating point on the children/adolescents clinical performance study dataset ... Global n(positive)= 1,000 n(negative)= 1,000 ... Sensitivity - 95% Clopper-Pearson CI 0.909 [0.889 - 0.926]”
specificity0.821CI 0.796 - 0.844
source quote (p.12)
“Specificity (with 95% Clopper-Pearson CI) and Sensitivity (with 95% Clopper-Pearson CI) of BoneView at the examination-level at the high-sensitivity operating point and high-specificity operating point on the children/adolescents clinical performance study dataset ... Global n(positive)= 1,000 n(negative)= 1,000 ... Specificity - 95% Clopper-Pearson CI 0.821 [0.796 - 0.844]”
sensitivityas written: “Sensitivity (Children/Adolescent, High-specificity operating point)”0.792CI 0.766 - 0.817
source quote (p.12)
“Sensitivity - 95% Clopper-Pearson Cl 0.792 [0.766 - 0.817]”
specificityas written: “Specificity (Children/Adolescent, High-specificity operating point)”0.965CI 0.952 - 0.976
source quote (p.12)
“Specificity - 95% Clopper-Pearson CI 0.965 [0.952 - 0.976]”
sensitivityas written: “Sensitivity (Adult, High-sensitivity operating point)”0.928CI 0.919 - 0.936
source quote (p.14)
“Sensitivity (with 95% Clopper-Pearson CI) and Specificity (with 95% Clopper-Pearson CI) of BoneView at the examination-level at the high-sensitivity operating point and high-specificity operating point on the merged datasets ... Global n(positive)= 3,886 n(negative)= 5,032 ... Sensitivity - 95% Clopper-Pearson CI 0.928 [0.919 - 0.936]”
specificityas written: “Specificity (Adult, High-sensitivity operating point)”0.811CI 0.8 - 0.821
source quote (p.14)
“Specificity (with 95% Clopper-Pearson CI) and Sensitivity (with 95% Clopper-Pearson CI) of BoneView at the examination-level at the high-sensitivity operating point and high-specificity operating point on the merged datasets ... Global n(positive)= 3,886 n(negative)= 5,032 ... Specificity - 95% Clopper-Pearson CI 0.811 [0.8 - 0.821]”
sensitivityas written: “Sensitivity (Adult, High-specificity operating point)”0.841CI 0.829 - 0.853
source quote (p.14)
“Sensitivity (with 95% Clopper-Pearson CI) and Specificity (with 95% Clopper-Pearson CI) of BoneView at the examination-level at the high-sensitivity operating point and high-specificity operating point on the merged datasets ... Global n(positive)= 3,886 n(negative)= 5,032 ... Sensitivity - 95% Clopper-Pearson CI 0.841 [0.829 - 0.853]”
specificityas written: “Specificity (Adult, High-specificity operating point)”0.932CI 0.925 - 0.939
source quote (p.14)
“Specificity (with 95% Clopper-Pearson CI) and Sensitivity (with 95% Clopper-Pearson CI) of BoneView at the examination-level at the high-sensitivity operating point and high-specificity operating point on the merged datasets ... Global n(positive)= 3,886 n(negative)= 5,032 ... Specificity - 95% Clopper-Pearson CI 0.932 [0.925 - 0.939]”
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
0
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).