(145 days)
L Vivo platform is intended for non-invasive processing of ultrasound images to detect, measure, and calculate relevant medical parameters of structures and function of patients with suspected disease.
The LVivo System analyzes echocardiographic patient examination DICOM movies for Global ejection fraction (EF) evaluation. EF is evaluated using two orthogonal planes, four-chamber (4CH) and two-chamber (2CH) views, to provide fully automated analyses of LV function from the echo examination movies. It also has the ability to measure strain and to evaluate the Right Ventricle and well as to measure the bladder.
This document describes the acceptance criteria and study results for DiA Imaging Analysis Ltd's LVivo Software Application, specifically focusing on its LVivoRV (Right Ventricular) and LVivo Bladder modules.
1. Table of Acceptance Criteria and Reported Device Performance
| Module | Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| LVivoRV | FAC Correlation | 75% correlation (r ≥ 0.75) between LVivoRV's FAC measurement and manual FAC measurements by sonographers. This value is based on statistical data reported by FDA cleared systems for semi-automated RV function evaluation (e.g., EchoInsight by Epsilon). | Primary Endpoint Met: Excellent correlation (r=0.79, p |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).