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The CardIQ Function is a software package that can be used in conjunction with CT Cardiac images to (semi-automatically) calculate and display various Left Ventricular and Right Ventricular functional parameters such as End Systolic and End Diastolic Volumes, Stroke Volume, LV Ejection Fraction including Peak Filling and Ejection Rates, Myocardial Mass Calculations, Regional Wall Motion Display and Analysis. When interpreted by a trained physician, the software aids in assessment of cardiac function and in determination of cardiovascular disease diagnosis and management.

CardIQ Function, also called CT-MASS, is a software package for the GE advantage Windows (AW) workstation. CardIQ Function is an image post processing and analysis package that allows the user to obtain the clinical relevant anatomical and functional information from Cardiac CT images to facilitate cardiovascular disease diagnosis and risk management. In particular it supports:

• Ability to input, load and display multi-phase, multi-location Cardiac CT image series. . Typically, these images are images along the short axis of the heart, reformatted from axial cardiac CT images.
• Display 3D or 4D image series as a function of either time variation within R-R period or ● locations along long and short axis.
• Manual or semi-automatic contour detection of either epicardium or endocardium edges of . ventricular chambers.
• Measure and display ventricular wall motion, wall thickness, myocardium mass, ventricle . volume and ejection fraction.
• Generating a patient/physician report, which contains cardiac function measurement data, . sample source images and processed images.

The provided document is a 510(k) summary for the CardIQ Function device. It states the device description, indications for use, and a comparison with a predicate device. However, it does not include information about acceptance criteria, device performance results, sample sizes for test or training sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies.

The document focuses on demonstrating substantial equivalence to a predicate device based on its functionality and intended use, rather than presenting detailed performance metrics against specific acceptance criteria.

Therefore, the requested information cannot be extracted from the provided text.

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