DASI Dimensions (V1.0)
DASI SimulationsDASI Dimensions (V1.0) is a clinical decision support software that processes multiphase CTA chest images to generate automated measurements of cardiovascular structures. It helps cardiologists and radiologists by providing detailed images and numerical data to support planning for aortic valve replacement procedures, improving accuracy and efficiency of pre-operative assessments.
Intended Use
DASI Dimensions is a standalone, non-invasive, clinical decision support software for use by cardiologists and radiologists in aortic stenosis patients, providing pre-defined images and measurements of cardiovascular structures to aid treatment decisions.
Technology
DASI Dimensions is an off-site post-processing software receiving multiphase CTA DICOM chest images uploaded via a web portal. It uses proprietary algorithms incorporating a static deep learning AI model to detect key aortic root points and calculate anatomical measurements relevant to pre-TAVR evaluation. Reports are quality checked by engineers before release.
Performance
Software verification and validation testing including AI model training/testing, measurement accuracy validation, operator variability assessment, human factors/usability testing, and cybersecurity testing were conducted. The device met predefined acceptance criteria for accuracy, precision, reliability, and safety without needing prospective clinical trials.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/8/2023
8 months - 2
FDA Approval
1/8/2024
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