BriefCase
Aidoc Medical, Ltd.BriefCase is an AI-powered software that analyzes head CT Angio (CTA) images to assist clinicians by flagging suspected Brain Aneurysm cases above 5 mm, helping prioritize urgent cases and improving workflow efficiency. It provides notifications and preview images but is not intended for primary diagnosis, supporting clinicians to review images faster and potentially reduce time to treatment.
Intended Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of head CT Angio (CTA) images to assist hospital networks and trained medical specialists in workflow triage by flagging and communicating suspected Brain Aneurysm cases above 5 mm size.
Technology
BriefCase is software with AI deep-learning algorithms running on Windows server and additional applications, processing DICOM 3.0 images. It includes three modules: Hospital Server (image acquisition), Cloud Server (image processing), and Worklist Application (user interface). It analyzes CT Angio series chronologically, flags suspected brain aneurysm cases, and sends notifications with compressed preview images that do not alter the original image or provide diagnostic markings.
Performance
A multi-center, retrospective pivotal study with 268 cases (96 positive) demonstrated sensitivity of 88.5% and specificity of 89.5% for brain aneurysm detection. Time-to-notification averaged 4.2 minutes versus standard-of-care time-to-exam-open of 89.4 minutes, potentially reducing workflow delay by over one hour. Negative predictive value was 98.9%, and positive predictive value was 42.4%.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/24/2021
3 months - 2
FDA Approval
3/21/2022
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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