(71 days)
DiaCardio's LVivo Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.
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
Here's a breakdown of the acceptance criteria and study information for the LVivo Software Application, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on the performance of the LVivoSG module and its correlation with established methods rather than explicit "acceptance criteria" presented as pass/fail thresholds. However, we can infer the desired performance from the study objectives and results.
| Metric | Acceptance Criteria (Inferred from Study Objectives) | Reported Device Performance (LVivoSG) |
|---|---|---|
| Global Longitudinal Strain (GLS) vs. VVI | Good agreement with correlation coefficient (r) ≥ 0.8 | r = 0.85 (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).