BriefCase
Aidoc Medical, Ltd.BriefCase by Aidoc Medical, Ltd. is an AI-based software that helps hospitals quickly identify and prioritize urgent head CT angiography scans with possible M1 Large Vessel Occlusion. It analyzes images and sends notifications with preview images to clinicians, enabling faster triage without replacing standard image interpretation.
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. It assists in workflow triage by flagging and communication of M1 Large Vessel Occlusion (M1-LVO) pathologies.
Technology
BriefCase consists of three modules—Aidoc Hospital Server for image acquisition, Aidoc Cloud Server for image processing, and Aidoc Desktop Application for workflow integration. The software uses a deep learning AI algorithm to analyze de-identified head CTA DICOM images to detect suspected M1-LVO cases and sends notifications with low-quality preview images to clinicians in parallel to their standard workflow.
Performance
Performance was validated in a retrospective, blinded, multicenter study using distinct datasets from those used in training. Sensitivity and specificity for detecting M1-LVO exceeded 80%, with sensitivity 88.8% and specificity 87.2%. The mean time-to-notification was 3.8 minutes, demonstrating rapid alerting comparable to predicate devices. Negative predictive value was 99.5%.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/5/2022
29 days - 2
FDA Approval
6/3/2022
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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