BriefCase
Aidoc Medical, Ltd.BriefCase is an AI-powered software that helps radiologists prioritize cervical spine CT scans by flagging possible fractures. It runs alongside standard image interpretation, notifying clinicians quickly about suspected cases to enable faster patient management, but it is not used for final diagnosis. This helps improve workflow efficiency and timely attention to urgent cases.
Intended Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of cervical spine CT images to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected linear lucencies in the cervical spine bone compatible with fractures. It presents notifications and compressed preview images for informational purposes only, not intended for diagnosis, and operates alongside standard care image interpretation.
Technology
The device uses an AI algorithm integrated in a software package that processes DICOM CT images from the cervical spine. It includes multiple modules: hospital server, cloud server, and a desktop worklist application that displays notifications on detected suspected fractures with compressed, unannotated preview images for triage purposes. It does not alter original images or remove them from the standard of care workflow queue.
Performance
A multicenter retrospective study with 186 cervical spine CT cases showed sensitivity of 91.7% and specificity of 88.6% for detecting fractures, exceeding the 80% performance goal. Time-to-notification was 3.9 minutes on average, compared to standard time-to-exam-open of 58.4 minutes, yielding an average 54.4 minute earlier alert to radiologists. Negative predictive value was 99%, positive predictive value 47.2%.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/5/2019
1 month - 2
FDA Approval
5/31/2019
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.