(71 days)
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).