BriefCase-Triage
Aidoc Medical, Ltd.BriefCase-Triage by Aidoc Medical, Ltd. is an artificial intelligence software that analyzes CT scans including the ribs to identify suspected acute rib fractures. It alerts clinicians with notification and preview images to help prioritize cases for faster review, aiding workflow triage without altering original images or serving as a diagnostic tool. This helps radiologists address urgent findings more efficiently.
Intended Use
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT images with or without contrast that include the ribs, in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies.
Technology
The software is an AI deep learning algorithm running on a Linux-based cloud server that processes DICOM CT images, analyzing each series to detect suspected rib fractures. It provides notifications and displays compressed, low-quality, grayscale preview images to users for triage purposes without altering the original images. It integrates with image routing modules and desktop applications for workflow integration.
Performance
A retrospective, blinded multicenter study of 308 CT cases showed an AUC of 97.2%, sensitivity of 95.2%, and specificity of 95.1% for detecting cases with three or more rib fractures, meeting pre-specified performance goals. Time-to-notification averaged 41.4 seconds versus 70.1 seconds for the predicate device, demonstrating comparable rapid notification benefit.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/15/2024
26 days - 2
FDA Approval
12/11/2024
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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