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Intended Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of abdominal CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of Intra-abdominal free gas (IFG) pathologies.

Technology

BriefCase uses an AI algorithm to analyze DICOM abdominal CT images received via a hospital PACS, running image processing to detect suspected intra-abdominal free gas. It operates with three modules: Aidoc Hospital Server for image acquisition, Aidoc Cloud Server for processing, and Aidoc Worklist Application for user interface and notification on radiologist desktops. It delivers notifications with compressed preview images for informational use only without altering original medical images.

Performance

A retrospective multicenter study evaluated BriefCase's performance on 184 abdominal CT cases (67 positive for IFG). Sensitivity was 91.0% and specificity 88.9%, exceeding 80% performance goals. Supplemental datasets showed consistent performance across various scanners. The software reduced average radiologist time to notification by approximately 90 minutes compared to standard time to exam review, supporting clinical benefit in workflow triage prioritization.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    11/27/2019

    6 months
  • 2

    FDA Approval

    6/19/2020

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