DeepXray is an AI-powered software that helps medical professionals analyze knee X-rays by automatically measuring joint space width and assessing signs of osteoarthritis such as sclerosis, joint space narrowing, and osteophytes. It supports clinicians by providing detailed grading based on established radiographic criteria and offers an interactive report for review and editing before finalizing.
Intended Use
DeepXray is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee.
Technology
DeepXray utilizes AI and computer vision algorithms to analyze knee radiographs for automated measurement of joint space width, femoral-tibial angle, and assessment of osteoarthritis features. It operates within Docker containers on a Linux server and outputs a web report with quality warnings, markup images, and an editing interface for clinicians to review and modify AI results.
Performance
Performance validation was conducted on an independent test dataset of 6,125 knee radiographs from 1,121 individuals from a multicenter longitudinal study (Osteoarthritis Initiative). The device showed high sensitivity and specificity for detecting Kellgren-Lawrence grade, joint space narrowing, osteophyte, and sclerosis. Quantitative measurements for joint space width and femoral-tibial angle showed strong agreement with physician-provided ground truth.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/5/2022
9 months - 2
FDA Approval
9/8/2023
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