(44 days)
The system, which is comprised of diagnostic reading software, is intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary obstructive disease.
The CardioCT (CCT) is a software application for viewing, evaluating and functionally analyzing cardiac CT images. The application is an interactive tool for radiologists and cardiologists and is used to visualize coronary anatomy, assess the state of the coronary arteries and execute functional analyses of the heart. This is accomplished by segmenting the heart tissues and coronary arteries and performing detailed evaluations of the coronary arteries and ventricular functions.
The supplied text is a 510(k) summary for the CardioCT device. However, it does not contain the acceptance criteria or a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Identifying the device (CardioCT) and its manufacturer (Shina Systems Ltd.).
- Stating its intended use (viewing, evaluating, and functionally analyzing cardiac CT images for radiologists and cardiologists).
- Claiming substantial equivalence to a predicate device (Philips Medical Systems Inc.'s Comprehensive Cardiac Analysis (CCA) module).
- Providing the FDA's clearance letter, regulation number, and product code.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The requested information regarding specific acceptance criteria, performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies is not present in this 510(k) summary.
§ 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).