Intended Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of chest CTs (with or without contrast). The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of three or more acute Rib fracture (RibFx) pathologies.

Technology

The software uses an artificial intelligence deep learning algorithm to analyze DICOM chest CT images, running algorithms on image series to detect suspect rib fracture cases. It operates on a standalone desktop application sending notifications and compressed preview images (not for diagnostic use) to prompt earlier triage. It does not alter original images or remove cases from the standard reading queue.

Performance

Performance was validated in a retrospective, blinded, multicenter, multinational study with 279 chest CT cases (91 positive for three or more rib fractures). The AI algorithm achieved AUC of 0.976, sensitivity 96.7%, specificity 90.4%. Time-to-notification was 4.2 minutes compared to 89.4 minutes for standard time-to-exam-open, potentially saving over one hour in clinical workflow.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    9/30/2020

    6 months
  • 2

    FDA Approval

    4/14/2021

Other devices from Aidoc Medical, Ltd.

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