Annalise Enterprise CXR Triage Trauma
Annalise-AI Pty LtdAnnalise Enterprise CXR Triage Trauma is an AI-based software tool designed to assist clinicians by analyzing adult chest X-ray images to detect features suggestive of vertebral compression fractures. It integrates with hospital image and order management systems to prioritize cases with potential fractures, facilitating timely review in clinical workflows such as Bone Health and Fracture Liaison Service programs. The device supports clinicians in identifying urgent cases but does not replace clinical decision-making.
Intended Use
Annalise Enterprise CXR Triage Trauma is a software workflow tool designed to aid the clinical assessment of adult chest X-ray cases with features suggestive of vertebral compression fracture in the medical care environment. It analyzes cases using an artificial intelligence algorithm for worklist prioritization or triage intended for clinicians in Bone Health and Fracture Liaison Service programs. Intended for trained clinicians qualified to interpret chest X-rays as part of their scope of practice.
Technology
The device uses an AI algorithm, specifically a convolutional neural network trained with deep-learning techniques, to identify vertebral compression fractures on chest X-rays. It integrates with PACS/RIS to receive images and provide notifications for worklist prioritization. The algorithm was trained on diverse datasets from multiple continents and validated with US board-certified radiologists serving as ground truthers.
Performance
Standalone performance evaluation was performed on 589 chest X-ray cases with a vertebral compression fracture AUC of 0.954 and sensitivity/specificity values around 85-90%. The device demonstrated effective triage capabilities with average turn-around time of 30 seconds, comparable to predicate devices. The testing included diverse patient demographics and equipment to ensure robustness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/28/2022
8 months - 2
FDA Approval
3/28/2023
Other devices from Annalise-AI Pty Ltd
- Annalise Enterprise CTB Triage Trauma2023 • 510K
- Annalise Enterprise CTB Triage Trauma2023 • 510K
- Annalise Enterprise CTB Triage-OH2023 • 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.