Annalise Enterprise CXR Triage Pneumothorax
Annalise-AIAnnalise Enterprise CXR Triage Pneumothorax is a software tool that uses artificial intelligence to analyze adult chest x-rays for signs of pneumothorax and tension pneumothorax. It assists trained clinicians by automatically prioritizing and triaging cases in their worklist, enabling faster attention to urgent findings. The device integrates with hospital imaging systems and helps optimize workflow without replacing clinical judgment.
Intended Use
The device is designed to aid the clinical assessment of adult chest x-ray cases with features suggestive of pneumothorax and tension pneumothorax in the medical care environment. It analyzes cases using an artificial intelligence algorithm to identify findings and outputs case-level results for worklist prioritization or triage in PACS or RIS. Intended for use by trained clinicians qualified to interpret chest x-rays as part of their scope of practice. Not intended as standalone diagnostic or to rule out pneumothorax.
Technology
Software integrates with RIS and PACS, uses a convolutional neural network trained on over 1.5 million chest x-rays from diverse datasets to detect pneumothorax and tension pneumothorax. Outputs case-level triage results to worklist software for prioritization. Uses deep learning with labeled data by radiologists. Allows configurable triage prioritization and does not downgrade existing priorities.
Performance
Performance evaluated in retrospective study of 949 chest x-rays with 413 positives (including 123 tension pneumo) and 536 negatives from multiple sites and imaging protocols. The device achieved high AUCs (0.979 pneumothorax, 0.988 tension pneumothorax), sensitivities and specificities above 80%, enabling clinically effective triage. Triage turnaround time averaged 20.57 seconds, comparable to predicate. Testing adhered to FDA performance guidelines for radiological triage software (21 CFR 892.2080).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/16/2021
2 months - 2
FDA Approval
2/24/2022
Other devices from Annalise-AI
- 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.