BriefCase
Aidoc Medical, Ltd.BriefCase is an artificial intelligence software that automatically analyzes CT chest with contrast scans to detect suspected cases of aortic dissection. It helps hospital networks and medical specialists by flagging possible cases to prioritize workflow and speed up patient triage. It provides notifications with preview images for informational use, aiding clinicians in prompt attention to urgent cases without replacing standard diagnostic procedures.
Intended Use
BriefCase is a radiological computer-aided triage and notification software indicated for use in the analysis of CT exams with contrast (CTA and CT with contrast) that include the chest in adults or transitional adolescents aged 18 and older. It assists hospital networks and trained medical specialists by flagging and communicating suspected positive cases of aortic dissection pathology to help triage workflow.
Technology
BriefCase consists of an AI algorithm component operating on a Windows server with additional modules: Aidoc Hospital Server for image acquisition, Aidoc Cloud Server for image processing, and Aidoc Desktop Application for workflow integration. The software receives, processes, de-identifies, and analyzes DICOM CT images to detect suspected cases using deep learning. It provides notifications with compressed preview images but does not alter original images or replace diagnostic processes.
Performance
A retrospective multicenter study evaluated the performance of BriefCase on 499 CT cases for detecting aortic dissection, distinct from training data. The software achieved 93.23% sensitivity and 92.83% specificity, exceeding the 80% performance goals. The mean time-to-notification was comparable to the predicate device (38 seconds vs. 36.5 seconds). Additional operating points provided tradeoffs between sensitivity and specificity while maintaining at least 80% confidence intervals.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/2/2022
1 month - 2
FDA Approval
9/28/2022
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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