BriefCase-Quantification
Aidoc Medical, Ltd.BriefCase-Quantification is an AI-powered radiological image management and processing software that analyzes contrast-enhanced CT images to measure the maximum axial diameter of the abdominal aorta. It assists trained medical specialists by providing preliminary measurements to help evaluate normal and aneurysmal abdominal aortas. The tool outputs annotated preview images, which serve as unofficial measurements to aid clinical review, with final decisions left to radiologists.
Intended Use
BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast, that include the abdominal aorta, in adults or transitional adolescents aged 18 and older. The device is intended to assist appropriately trained medical specialists by providing the user with the maximum abdominal aortic axial diameter measurement of cases that include the abdominal aorta (M-AbdAo). It is indicated to evaluate normal and aneurysmal abdominal aortas and is not intended to evaluate post-operative aortas.
Technology
BriefCase-Quantification is a software system based on an algorithm programmed component that runs on a cloud-based Linux server. It processes filtered DICOM CT images chronologically to measure the maximum abdominal aortic diameter. The output is an annotated preview image with the diameter measurement, which is unofficial and not final, viewed through a PACS-compatible image review software.
Performance
A blinded, multicenter retrospective study on 160 CT cases compared the AI measurements to ground truth established by three US board-certified radiologists. The mean absolute error between AI and reference measurements was 1.95 mm with 95% CI 1.59 to 2.32 mm, meeting the prespecified performance goals and demonstrating performance comparable to a predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/27/2023
8 months - 2
FDA Approval
11/8/2023
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
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- BriefCase-Triage2024 • 510K
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