(120 days)
- Delineate the contours of blood in vessels and through heart valves in Phase-Contrast MR images; manually, semi-automatically or automatically.
- Derive from these images and contours quantitative cardiovascular analysis results. The CAAS MR Flow has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as for research purposes like clinical research trials.
The CAAS MR Flow is a software tool providing functionality to import and view MR flow datasets and corresponding reference images. Contours of blood in vessels and through heart valves can be delineated automatically, semi-automatically or manually. Within these contours data on flow and velocity can be derived and parameters of interest for clinical use based on these contours and on results of the analysis are available on screen as well as hardcopy, and can be saved.
The provided text is a 510(k) summary for the CAAS MR Flow device, which is an image processing system for magnetic resonance flow analysis. The document establishes substantial equivalence to predicate devices but does not contain information regarding specific acceptance criteria, a study proving the device meets those criteria, or details of such a study (sample size, ground truth, expert qualifications, etc.).
Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The document focuses on regulatory compliance and substantial equivalence, not detailed performance validation study results.
§ 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).