ClearRead CT CAC
Riverain Technologies, Inc.ClearRead CT CAC is software that helps physicians assess coronary artery calcification on non-contrast, non-gated chest CT scans. It automatically detects and quantifies calcified coronary lesions, providing an Agatston score and categorization to aid in cardiovascular risk assessment. This allows clinicians to efficiently obtain quantitative calcium scoring to help guide patient management, supplementing but not replacing clinical expert review.
Intended Use
ClearRead CT CAC is image processing software designed to aid physicians in assessing coronary artery calcification on non-gated, non-contrast, standard, or low-dose chest CT scans of adult patients 30 years of age or older.
Technology
ClearRead CT CAC receives chest CT DICOM images, employs AI to automatically detect and segment calcified coronary lesions, and calculates the Agatston score per artery and total score calibrated to 3.0mm slice thickness. The system outputs results for physician review as adjunctive information.
Performance
Performance was evaluated with approximately 400 held-out cases for internal validation and a clinical study with 491 cases from multiple sites. The device achieved a weighted kappa score of 0.959 for Agatston score category accuracy, Bland-Altman analysis showed strong agreement, and Dice scores for segmentation were high (0.892 to 0.910). These results demonstrate safety and efficacy for intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/25/2024
4 months - 2
FDA Approval
12/3/2024
Other devices from Riverain Technologies, Inc.
- ClearRead Xray Pneumothorax2022 • 510K
- ClearRead CT2016 • 510K
- CLEARREAD +CONFIRM2012 • 510K
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