(147 days)
DiaCardio's LVivo EF Software Application is intended for non-invasive processing of already acquired echocardiographic images in order to detect, measure, and calculate the left ventricular wall for left ventricular function evaluation. This measurement can be used to assist the clinician in a cardiac evaluation.
The LVivoEF 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.
Here's a breakdown of the acceptance criteria and study details for the LVivo EF Software Application (K130779), based on the provided text:
Acceptance Criteria and Device Performance
The provided text only explicitly states one primary endpoint and the corresponding result. The exact acceptance criteria (i.e., the numerical threshold for success) are not explicitly stated, but the device's performance is reported to have met this primary endpoint.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Strong positive correlation between LVivoEF and Manual Biplane Method (MBP) for biplane Ejection Fraction (EF) | Pearson correlation coefficient (r) = 0.88, 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).