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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) images in adults or transitional adolescents aged 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspect cases of three or more acute Rib fracture (RibFx) pathologies.

Technology

BriefCase uses an artificial intelligence deep learning algorithm to analyze filtered DICOM chest CT images and identify suspected acute rib fractures. It runs on a Linux-based server in a cloud environment and integrates with an image review software to notify users with compressed preview images for triage, without altering original images or providing diagnostic markings.

Performance

A retrospective, blinded multicenter study on 308 chest CT cases showed that BriefCase achieved AUC of 0.98, sensitivity of 98.08%, and specificity of 93.14% in detecting cases with three or more acute rib fractures. The time-to-notification was significantly faster (mean ~70 seconds) compared to the predicate device (mean 252 seconds), demonstrating effective and timely triage support.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    1/3/2023

    29 days
  • 2

    FDA Approval

    2/1/2023

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