BoneView 1.1-US is an AI-powered software designed to assist clinicians by analyzing X-ray radiographs to identify and highlight fractures. It works as a concurrent reading aid, helping improve the accuracy and speed of fracture diagnosis across multiple anatomical regions including limbs, pelvis, ribs, and spine for both adults and pediatric patients. The software integrates seamlessly with imaging systems like PACS and can be deployed on-premise or in the cloud, enhancing radiologists' ability to detect subtle and definite fractures.
Intended Use
BoneView 1.1-US is intended to analyze radiographs using machine learning techniques to identify and highlight fractures during the review of radiographs across multiple body regions for adults and children/adolescents as a concurrent reading aid.
Technology
BoneView is a software-only device that automatically receives radiographs via DICOM from PACS or X-ray systems, processes the images with an AI algorithm to identify regions of interest (suspected fractures), and generates annotated result files that are sent back in DICOM format for visualization. It features high sensitivity and specificity thresholds for fracture detection, displays solid or dotted bounding boxes to indicate confidence levels, and can be deployed on-premise or on-cloud.
Performance
Performance testing included standalone validation and retrospective multiple reader multiple case (MRMC) clinical performance studies demonstrating high sensitivity and specificity in fracture detection on radiographs from adult and pediatric populations, across multiple anatomical sites and various X-ray systems. Statistical results showed improved reader sensitivity and specificity when aided by BoneView compared to unaided reads, confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/22/2022
7 months - 2
FDA Approval
3/2/2023
Other devices from Gleamer
- BoneView2022 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.