BriefCase-Triage
Aidoc Medical, Ltd.BriefCase-Triage is an AI-based radiological software designed to assist clinicians by automatically analyzing contrast-enhanced CT images including the lungs to detect suspected cases of incidental pulmonary embolism. It notifies users with preview images for triage and prioritization, enabling faster attention to critical cases without replacing standard diagnostic workflows.
Intended Use
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced images that include the lungs in adults or transitional adolescents age 18 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communication of suspect cases of incidental Pulmonary Embolism (iPE) pathologies.
Technology
The device utilizes a deep learning artificial intelligence algorithm integrated into a software package operating on a Linux-based cloud server. It processes filtered DICOM CT images chronologically to detect suspected PE cases, and sends notifications with compressed, grayscale preview images for triage. It does not alter original images and integrates with image communication platforms and desktop applications for workflow integration.
Performance
A retrospective, multicenter study of 498 cases was conducted comparing the software performance to ground truth established by board-certified radiologists. Sensitivity was 91.7% and specificity 91.4%, both exceeding an 80% performance goal. Time-to-notification averaged 40.2 seconds, demonstrating significant time savings compared to the predicate device (282 seconds). Additional operating points with varying sensitivity and specificity levels were also validated.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/27/2025
18 days - 2
FDA Approval
2/14/2025
Other devices from Aidoc Medical, Ltd.
- BriefCase-Triage2025 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Quantification2024 • 510K
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