Rayvolve is an AI-powered software tool that helps radiologists and emergency physicians detect fractures on X-rays of the musculoskeletal system. It analyzes various standard radiographic views of bones like ankle, clavicle, elbow, hip, knee, and more, providing accurate fracture detection to support clinical decision-making.
Intended Use
Rayvolve is a computer-assisted detection and diagnosis (CAD) software device to assist radiologists and emergency physicians in detecting fractures during the review of radiographs of the musculoskeletal system for adults (≥ 22 years old).
Technology
Rayvolve uses supervised deep learning algorithms to detect and localize fractures on osteoarticular X-rays. It works as standalone software interoperating with PACS servers, processing diverse radiograph datasets from multiple countries to ensure high generalizability.
Performance
Performance was evaluated with standalone testing on 2626 adult radiographs showing high accuracy for fracture detection (AUC=0.986, sensitivity=0.988, specificity=0.886) across multiple subgroups and imaging device types. A clinical reader study showed improved diagnostic accuracy when radiologists used Rayvolve (AUC increased from 0.846 to 0.893, sensitivity improved to 0.955).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/20/2022
4 months - 2
FDA Approval
6/2/2022
Other devices from AZmed SAS
- Rayvolve2024 • 510K
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