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Delineate the outline of the right ventricular wall semi-automatically or manually in angiographic X-ray images - either monoplane or biplane analysis; absolute measurements of right ventricular volumes based on several established models for children and adults - calculations of derived parameters; quantification of the motion of the right ventricular wall.

The CAAS II RVA is one of the software modules intended to run on the Cardiovascular Angiography Analysis System mark II, CAAS II. It functions in the same manner as left ventricular analysis software packages. In the End Diastolic (ED) and End Systolic (ES) images (of a monoplane or biplane run), available from various image sources, the outline of the left ventricular contour is either drawn manually or semi-automatically. From these contours the ventricular volumes, the ejection fraction and other related parameters are determined using several well established volume models for the right ventricle. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall between ED and ES is quantified from these ventricular contours using the well known Centerline model. All results of the analysis are available on screen as well as hardcopy.

The provided text describes the CAAS II RVA software package and its substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a study proving that the device meets specific performance metrics.

The 510(k) summary focuses on:

• Device identification: Trade name, common name, classification, and contact information.
• Intended use: Delineation of right ventricular wall, absolute measurements of right ventricular volumes, calculation of derived parameters, and quantification of wall motion.
• Technological characteristics: States that it functions similarly to left ventricular analysis software, using manual or semi-automatic contouring and established volume models.
• Substantial equivalence: Compares it to the CAAS II LVA-Biplane Option (K982203) based on similar technological characteristics and intended use.
• Regulatory information: FDA classification, premarket notification details, and general controls.

Therefore, I cannot provide the requested table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided text.

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