VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is an AI-based software tool that analyzes adult chest X-rays to detect critical conditions such as pleural effusion and pneumothorax. It prioritizes cases in the clinical workflow by providing passive notifications in the radiologist's PACS or workstation, helping healthcare professionals manage urgent cases efficiently. The software supports DICOM and common image formats and is intended to assist rather than replace clinical decision-making.
Intended Use
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). It uses an AI algorithm to analyze images and provides case-level output for worklist prioritization or triage in PACS/workstation.
Technology
The device uses a convolutional neural network (CNN) based deep learning AI algorithm trained on chest X-ray data from medical centers across South Korea and India. It analyzes frontal chest radiographs in DICOM, JPG, or PNG formats, identifies features suggestive of pleural effusion and pneumothorax, and provides passive notifications in the PACS/workstation worklist without marking the original images.
Performance
Performance was validated on retrospective chest X-ray datasets including 716 pneumothorax and 1,200 pleural effusion scans, sourced from diverse US regions and device vendors. The device achieved ROC AUC > 0.95 with sensitivity and specificity above 95% for both conditions, with notification timing under 10 seconds. Subgroup analyses demonstrate robust performance across ages, genders, view positions, datasets, and device vendors.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/21/2024
5 months - 2
FDA Approval
11/15/2024
Other devices from Vuno Inc.
- VUNO Med-DeepBrain2023 • 510K
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