BriefCase-Triage
Aidoc Medical, Ltd.BriefCase-Triage is an AI-powered software designed to assist hospital networks and trained radiologists in identifying suspected pulmonary embolism cases from CT pulmonary angiography (CTPA) images. The software analyzes images in parallel with standard interpretation, flags potential positive findings, and notifies clinicians with compressed preview images for triage purposes, helping prioritize urgent cases and reduce turnaround times 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 CTPA images in adults or transitional adolescents aged 18 and older. It assists hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of Pulmonary Embolism (PE). The device uses AI to analyze images and highlight suspected PE findings, providing non-diagnostic preview notifications to assist triage.
Technology
The software is a radiological computer-assisted triage and notification tool operating on a Linux-based server in a cloud environment. It processes filtered DICOM CT images chronologically with a deep learning algorithm trained on manually labeled data to detect suspected pulmonary embolism. The output is transferred to an image review desktop application that notifies users with compressed, grayscale preview images for prioritization, without modifying the original images or workflow.
Performance
A retrospective, blinded, multicenter study of 499 CTPA cases from six US clinical sites compared BriefCase-Triage results to consensus ground truth from three senior radiologists. Sensitivity and specificity both exceeded 80%, with sensitivity at 94.39% and specificity at 94.39%. Time-to-notification averaged 26.42 seconds, substantially faster than the predicate device’s 78 seconds, demonstrating efficiency in workflow triage without impacting standard of care.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/14/2024
28 days - 2
FDA Approval
7/12/2024
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Quantification2024 • 510K
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