BriefCase
Aidoc Medical, Ltd.BriefCase by Aidoc Medical, Ltd. is an AI-powered software that assists radiologists by automatically analyzing chest and abdominal CT scans to detect and flag suspected vertebral compression fractures. It helps prioritize medical images for review, enabling faster triage without altering original images or workflows, thus improving the efficiency of radiological diagnosis and patient care.
Intended Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of chest and abdominal CT images. The device is intended to assist hospital networks and appropriately trained medical specialists within the standard-of-care bone health setting in workflow triage by flagging and communication of suspected positive cases of Vertebral Compression Fractures (VCFx) findings.
Technology
BriefCase is an AI-based software consisting of three modules: Aidoc Hospital Server (image acquisition), Aidoc Cloud Server (image processing), and Aidoc Desktop Application (workflow integration). Uses AI deep-learning algorithms to process de-identified DICOM chest and abdominal CT images to detect suspected vertebral compression fractures. It displays non-diagnostic low-quality previews for prioritization without altering original images or workflow.
Performance
The pivotal multicenter retrospective study on 318 cases demonstrated BriefCase achieved an AUC of 97.6%, sensitivity of 95.11%, and specificity of 93.28% for detecting vertebral compression fractures, meeting pre-specified performance goals. Time-to-notification was 117.2 seconds, comparable to the predicate device, indicating effective prioritization in clinical workflow.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/6/2022
3 months - 2
FDA Approval
12/5/2022
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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