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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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The Chase Cardiac Analysis System is indicated for use by trained physicians to derive anatomical and functional information from cardiac magnetic resonance image (MRI) studies. This information is presented as both an interactive 3D model and as text reports. The System is designed to automate the segmentation of cardiac structure and calculate anatomical and functional parameters and this information, when interpreted by a trained physician, may be helpful in diagnosis and therapeutic decisions.

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I am sorry, but the provided text from the FDA 510(k) summary for the "Chase Cardiac Analysis System" does not contain the information requested regarding acceptance criteria and the study proving device performance.

The document is a clearance letter from the FDA stating that the device has been found substantially equivalent to a legally marketed predicate device. It defines the device indications for use but does not detail the specific performance studies, acceptance criteria, or the results of such studies.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, ground truth establishment, or multi-reader multi-case studies based on the provided text. This type of detailed performance data is typically found in the full 510(k) submission, which is not publicly available in this format.

Ask a specific question about this device