Rapid RV/LV
iSchema View Inc.Rapid RV/LV is a medical imaging software designed to assist clinicians by automatically measuring the sizes of the right and left heart ventricles from CT pulmonary angiography scans. It provides annotated images and quantitative measurements to help assess right-heart strain, supporting clinical decision-making in cardiopulmonary conditions. The software uses machine learning to locate the ventricles and report their size ratio.
Intended Use
The Rapid RV/LV software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements for adults.
Technology
Radiological computer-assisted image processing software that analyzes volumetric CTPA images in DICOM format using machine learning algorithms to identify and measure right and left ventricular diameters. It outputs annotated images with marked measurements and quantitative results in JSON format. The system operates fully automated within the integrated Rapid Platform.
Performance
Performance validation testing included 124 CTPA cases with expert-established ground truth, demonstrating the device's accuracy in measuring ventricular diameters. The primary endpoint showed high agreement with experts (average slope 1.1, intercept -0.2) and a low mean bias (0.023). The mean absolute error compared to experts was 3.8 mm. Testing covered a range of patient ages and scanner types. Software verification and validation confirmed compliance with design specifications.
Predicate Devices
No predicate devices specified
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