(171 days)
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.
Not Found
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.
§ 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).