BoneXpert is an AI-powered software tool that helps pediatric radiologists assess bone age from hand X-ray images. By automatically analyzing hand radiographs of children, it provides an objective estimate of bone age, supporting clinicians in evaluating growth and development without replacing their medical judgment.
Intended Use
BoneXpert is designed to view and quantify bone age from 2D Posterior Anterior (PA) hand radiographs using machine learning techniques to aid in the analysis of bone age assessment of patients between 2-21 years old for pediatric radiologists. The results should not be relied upon alone to make diagnostic decisions. The images shall be without any major bone deformity and without excessive image postprocessing (edge enhancement).
Technology
BoneXpert is DICOM image processing software installed on a Windows system within the hospital network. It uses machine learning algorithms to analyze pediatric hand radiographs (left or right), validates image quality, and returns annotated DICOM images with bone age and supplementary information. It operates via the standard radiology workflow, integrating with PACS.
Performance
BoneXpert underwent clinical and bench testing. The primary clinical evidence was a multicenter study of 1,285 images from five U.S. sites, showing BoneXpert's accuracy (lower RMSE than a single manual rater, fewer large deviations, and model-based accuracy comparable to or better than human rater variability). Additional studies validated output accuracy, robustness to image quality, precision, and appropriateness of self-validation rejection rates. These results demonstrate safety, effectiveness, and robustness.
Predicate Devices
No predicate devices specified
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