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• Delineate the inner and outer wall of the ventricles automatically, semi-automatically or manually, as well as the papillary muscles, on different kinds of MRI images.
• Derive from these images and contours quantitative information to be used to assist in cardiac analysis
  The CAAS MRV has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as for research purposes like clinical research trials.

The CAAS MRV is a software tool designed for the functional analysis of the heart based on multi-slice, multi-phase MR images of the heart. Therefore it provides functionality to import and view cine MR datasets of the heart from several vendors from CDROM, hard disk or (optionally) a PACS system. Next, the inner and outer wall of the ventricles can be determined either automatically, semi-automatically or manually. From these contours the ventricular volume, the ejection fraction and other related parameters are determined. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall is quantified. All results of the analysis are available on screen as well as hardcopy, and can be saved.

This 510(k) summary does not contain the detailed acceptance criteria or a study demonstrating the device meets such criteria. It focuses on establishing substantial equivalence to a predicate device and describing the intended use and technological characteristics.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence rather than presenting specific performance study results against defined acceptance criteria.

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