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The Chase Cardiac Analysis System is indicated for use by trained physicians to derive anatomical and functional information from digital images acquired from a variety of imaging modalities including: magnetic resonance, computed tomography. This information is presented as both an interactive 3D model and as text reports. The System is designed to assist the analysis of coronary vessels, provide semi-automatic segmentation of cardiac structure and automatic calculation of anatomical and functional parameters. This information, when internreted by a trained physician, may be helpful in diagnosis and therapeutic decisions.

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I apologize, but the provided text is a 510(k) clearance letter from the FDA for the "Chase Cardiac Analysis System." This document primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to a predicate device.

The document does not contain the detailed information necessary to answer your request regarding acceptance criteria, study design, expert qualifications, or specific performance metrics.

Therefore, I cannot provide the requested table or the other specific details about the study that proves the device meets acceptance criteria.

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