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Intended Use

BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CTs (not dedicated CTPA protocol) in adults or transitional adolescents age 18 and older. It assists hospital networks and trained specialists in triage by flagging suspect cases of incidental Pulmonary Embolism (iPE). It operates on single-energy exams only, providing notifications and non-diagnostic preview images to aid prioritization alongside standard care imaging.

Technology

BriefCase is an AI algorithm-based software system that runs on a Windows server environment and consists of hospital server (AHS), cloud server (ACS), and a desktop worklist application. It processes DICOM chest CT images, filters, de-identifies, and runs AI triage algorithms on them, then sends notifications with low-quality, compressed, non-diagnostic preview images to users in parallel with the standard radiology workflow. The software does not alter original images or remove cases from the diagnostic queue.

Performance

A retrospective, blinded, multicenter study on 159 contrast-enhanced chest CT cases (acquired from Philips and Toshiba scanners) showed the BriefCase software achieved sensitivity of 89.7% and specificity of 90.1% for detecting incidental Pulmonary Embolism. These results met the performance goals. Time to notification improved significantly compared to standard care, with notifications delivered within minutes, enhancing workflow turnaround time.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    12/13/2021

    4 months
  • 2

    FDA Approval

    4/26/2022

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