uAI EasyTriage-Rib
Shanghai United Imaging Intelligence Co., Ltd.The uAI EasyTriage-Rib is a software tool that uses artificial intelligence to analyze CT chest images and help radiologists prioritize trauma cases with suspected multiple acute rib fractures. It assists in workflow triage by flagging cases with suspected findings, allowing faster and more efficient patient management without altering the original medical images or making diagnoses itself.
Intended Use
uAI EasyTriage-Rib is a radiological computer-assisted triage and notification software device for analysis of CT chest images. It assists hospital networks and trained radiologists by flagging and prioritizing trauma studies with suspected three or more acute rib fractures.
Technology
The device uses an artificial intelligence deep learning algorithm trained on medical CT images to detect and flag studies with suspected multiple acute rib fractures. It consists of a server module and a user interface application that provides notifications with compressed preview images for triage purposes. It operates in parallel to standard care without altering original medical images or providing diagnostic conclusions.
Performance
A retrospective, blinded multicenter study on 200 CT chest cases showed the device achieved 92.7% sensitivity and 84.7% specificity for detecting multiple (3 or more) acute rib fractures, with an AUC of 0.939. The time-to-notification was 69.56 seconds, comparable to a predicate device. Performance data support effective triage and notification functionality, demonstrating safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/26/2019
1 year, 1 months - 2
FDA Approval
1/15/2021
Other devices from Shanghai United Imaging Intelligence Co., Ltd.
- uAI Easy Triage ICH2024 • 510K
- uAI Portal2024 • 510K
- uMR 6802023 • 510K
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