BriefCase-Quantification
Aidoc Medical, Ltd.BriefCase-Quantification is an AI-powered software that automatically measures brain midline shift in non-contrast head CT scans, assisting medical specialists by automating a typically manual measurement process. It provides quantitative analysis and comparative reports over time to help clinicians monitor patients, without altering original images or serving as a standalone diagnostic tool.
Intended Use
BriefCase-Quantification of Midline Shift (MLS) is a radiological image management and processing system software intended for automatic measurement of brain midline shift in non-contrast head CT (NCCT) images, in adults or transitional adolescents aged 18 years and older.
Technology
The software is a single module AI deep-learning algorithm running on a Linux-based cloud server, processing filtered DICOM NCCT images to quantify midline shift. It outputs measurements and annotated images to PACS or desktop applications, providing reports with slice previews and comparative analysis over time.
Performance
A retrospective, blinded, multicenter study on 284 cases from 228 patients showed the mean absolute error of the AI's midline shift measurement compared to neuroradiologist ground truth was 0.94 mm, meeting prespecified performance goals. Bland-Altman analysis indicated little bias. Multiple time point testing also met performance goals.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/13/2023
4 months - 2
FDA Approval
11/13/2023
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