Logo
RadAI Slice
Subscribe

Intended Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images in adults or transitional adolescents aged 18 and older, assisting hospital networks and trained medical specialists in workflow triage by flagging and communicating suspected positive findings of Intracranial hemorrhage (ICH) pathologies.

Technology

BriefCase is composed of three modules: Aidoc Hospital Server for image acquisition, Aidoc Cloud Server for image processing, and Aidoc Desktop Application for workflow integration. It uses AI deep learning algorithms on de-identified DICOM 3.0 compliant CT images to detect suspected ICH, sending notifications with compressed preview images meant for informational purposes only without altering original images or diagnostic use.

Performance

Performance testing included a retrospective, blinded, multicenter study with 220 head CT cases. Sensitivity was 96.15%, specificity was 94.83%, exceeding an 80% performance target. Time-to-notification was approximately 33.5 seconds, significantly faster than predicate device (267.6 seconds), aiding quicker triage. Negative predictive value was 99.29%, positive predictive value was 76.64%.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    4/29/2022

    18 days
  • 2

    FDA Approval

    5/17/2022

Other devices from Aidoc Medical, Ltd.

View all 27 devices

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.