BriefCase
Aidoc Medical, Ltd.BriefCase by Aidoc Medical is an AI-powered software that analyzes head CT angiography images to detect suspected large and medium vessel occlusions. It assists trained medical specialists by providing notifications of suspected positive findings to help prioritize and triage cases for faster review. It operates alongside standard workflows without altering original medical images, helping clinicians identify urgent cases more quickly.
Intended Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CTA images 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 findings of complete Large Vessel Occlusion (LVO) and Medium Vessel Occlusions (MeVO).
Technology
BriefCase is a software system based on an AI deep learning algorithm running on a standard Windows server platform, with modules for image acquisition, processing, and workflow integration. It receives DICOM CTA images, filters and de-identifies them, then analyzes series chronologically using the AI algorithm to detect vessel occlusions. Notifications and compressed low-quality preview images are sent to users to aid preemptive triage without altering the original images or workflow.
Performance
A retrospective, blinded multicenter study evaluated BriefCase on 342 head CTA cases for detection of vessel occlusions. The device achieved sensitivity of 91.3% and specificity of 85.6%, exceeding the 80% performance goal. The mean time-to-notification was 2.23 minutes, faster than the predicate device's 3.8 minutes, demonstrating effective preemptive triage. Positive and negative predictive values, likelihood ratios, and sub-analyses on vessel segments were also reported, supporting safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/10/2022
7 months - 2
FDA Approval
10/7/2022
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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