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CardEP is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used for the analysis of CT angiographic images for the assessment of the heart to include the atria, pulmonary veins, and coronary sinus. It provides quantitative analysis tools which include a number of display, measurement and model export capabilities. This product can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.

The CardEP option is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used in the analysis of CT angiographic images to display structures of the heart in a MIP, reformat, volume rendering and vessel fly through view. The software has an ability to automatically segment out cavities of the heart, measure the diameter of the vessels and export models of the heart for further review.

The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. It is a 510(k) summary for the CardEP software, focusing on its substantial equivalence to a predicate device.

Therefore, I cannot provide a table of acceptance criteria, reported performance, or details about a study demonstrating the device meets acceptance criteria. The document primarily discusses:

• Product Identification: Name, classification, manufacturer, distributor.
• Device Description: Post-processing software for CT angiographic images to display and analyze heart structures (MIP, reformat, volume rendering, vessel fly-through, automatic segmentation, diameter measurement, model export).
• Indications for Use: Analysis of CT angiographic images for assessment of the heart, including atria, pulmonary veins, and coronary sinus, providing quantitative analysis tools to aid trained physicians.
• Comparison with Predicate: CardEP is stated to be substantially equivalent to CT CardiQ Analysis II (K020796).
• Adverse Effects on Health: Identified risks are controlled by software development, validation, verification processes, and adherence to standards.
• Conclusions: No new potential safety risks, performs as well as devices currently on the market.
• FDA Clearance Letter: Official letter granting 510(k) clearance based on substantial equivalence.

Key Absence: The document does not describe performance metrics, clinical study design, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or adjudication methods. It focuses on the regulatory aspect of substantial equivalence, which often relies on a comparison of features and intended use rather than a detailed performance study against specific acceptance criteria.

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