BriefCase-Triage
Aidoc Medical , Ltd.BriefCase-Triage by Aidoc Medical, Ltd. is an AI-powered software that assists clinicians by automatically analyzing CT brain images to detect suspected brain aneurysms 3.0 mm or larger. It flags these cases and notifies medical specialists to prioritize their workflow, enabling faster review of critical cases without altering the original images or providing diagnostic decisions.
Intended Use
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced CT images that include the brain, 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 communication of suspected positive cases of Brain Aneurysm (BA) findings that are 3.0 mm or larger.
Technology
The device uses an AI deep learning algorithm deployed in a cloud environment to process filtered DICOM CT brain images. It runs the algorithm on each image series chronologically to detect suspect cases, then sends a compressed, low-quality grayscale preview image to the user as a notification popup. It integrates with image communication platforms and does not alter original images or prioritize diagnostic use beyond triage notification.
Performance
A multicenter, retrospective, blinded pivotal study on 544 contrast-enhanced CT brain cases showed sensitivity of 87.8% and specificity of 91.6%, surpassing the 80% performance goal. Time-to-notification averaged 44.8 seconds, significantly faster than the predicate device's 252 seconds. Additional operating points confirmed robust performance across sensitivity and specificity trade-offs. The device operates in parallel to standard of care without altering workflow priorities.
Predicate Devices
No predicate devices specified
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