EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
Ever Fortune.AI Co., Ltd.The EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is software that uses deep learning to analyze left-hand X-ray images in pediatric patients aged 2 to 16 years. It estimates bone age to assist pediatric radiologists in clinical decision-making. The system integrates with existing PACS workflows, providing bone age assessments to support but not replace radiologist interpretation.
Intended Use
Designed to view and quantify bone age from 2D posterior anterior (PA) view of left-hand radiographs using deep learning techniques to aid in the analysis of bone age assessment of patients between 2 to 16 years old for pediatric radiologists.
Technology
Software uses AI deep learning to analyze left-hand PA X-ray images according to the Greulich-Pyle method to quantify bone age. Outputs are sent as standardized JSON data for integration with PACS and other systems. The software provides adjunct quantitative data without replacing clinician judgment.
Performance
Performance was validated using a large retrospective dataset from Taiwan and US (26,222 cases) and a clinical study of 600 cases across multiple US sites. Results showed strong correlation to ground truth assessments from board-certified radiologists with Deming regression intercept near zero and slope near one. Subgroup analyses by age, gender, ethnicity, and image quality showed consistent performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/21/2023
5 months - 2
FDA Approval
6/7/2024
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