Annalise Enterprise CXR Triage Trauma
Annalise-AI Pty LtdAnnalise Enterprise CXR Triage Trauma is an artificial intelligence-based software that assists clinicians by automatically analyzing adult chest X-rays to identify signs of pleural effusion and pneumoperitoneum. It integrates with hospital imaging systems to prioritize urgent cases in the clinical workflow, helping healthcare providers quickly identify critical findings and streamline patient care.
Intended Use
Software workflow tool designed to aid the clinical assessment of adult chest X-ray cases with features suggestive of pleural effusion and pneumoperitoneum in the medical care environment. It analyzes cases using an AI algorithm to identify findings and provides case-level output to PACS or RIS for worklist prioritization or triage.
Technology
The device uses a deep learning convolutional neural network AI algorithm trained on diverse chest X-ray datasets to identify pleural effusion and pneumoperitoneum. It integrates with image and order management systems like PACS/RIS to automatically analyze studies and notify for triage prioritization. Ground truth for training and validation was established by board-certified radiologists.
Performance
Standalone performance was validated on 1269 independent chest X-rays showing high accuracy (AUC ~0.98 for pleural effusion and 0.97 for pneumoperitoneum) with strong sensitivity and specificity values across operating points. Triage effectiveness showed average turn-around time under 30 seconds. These results demonstrate safety, effectiveness, and substantial equivalence to a predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/22/2022
8 months - 2
FDA Approval
3/28/2023
Other devices from Annalise-AI Pty Ltd
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- Annalise Enterprise CTB Triage-OH2023 • 510K
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