(227 days)
UW LV Analysis Software assists in measuring left ventricular volume at end diastole and end systole, ejection fraction, and regional wall motion around the ventricular contour. The intended applications of the software are: 1) to assist in evaluating a patient with suspected heart disease, 2) to measure the effectiveness of therapy, 3) to assess risk or prognosis, and 4) in clinical trials evaluating new therapies.
The method comprises five main parts: a) reviewing the digital images, b) selecting the image frames to analyze, c) identifying and tracing the border of the left ventricle, d) measuring left ventricular volume from the traced border and calculating ejection fraction, and e) measuring regional wall motion. The UN LV Analysis Software allows the user to review a series of images in digital format, and manually select frames for analysis. Identifying and tracing the ventricular border is performed manually using the Of the techniques developed to measure left LV Analysis Software. UW ventricular volume from a traced border, the area length method is generally the most accurate, and is the method used by the UW LV Analysis accepted as Software. Of the techniques for measuring left ventricular wall motion, the centerline method has been proven useful for clinical trials, and is the method used by the UW LV Analysis Software. Calibration to correct for image magnification is required for volume measurement, but not for calculation of the ejection fraction or for analysis of regional wall motion.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details, presented in the requested format:
Acceptance Criteria and Device Performance Study
The provided document describes the UW LV Analysis Software, which assists in measuring left ventricular volume, ejection fraction, and regional wall motion. This software is largely a manual tool with automated calculations based on user input.
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Difference from reference programs (volume & regional wall motion) |
§ 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).