(93 days)
CMRtools™ and plug-ins VentricularTools™ & ThalassaemiaTools™ is a software device used for viewing and analyzing cardiovascular magnetic resonance images. It allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plugins have comprehensive quantification facilities with full analysis session recording for providing comprehensive audit trails. It contains an image viewer for importing DICOM images, browsing through patient datasets, viewing cine images and performing region-of-interest analysis.
Plug-ins are used for specialist cardiac assessment including VentricularTools for left ventricular assessment and ThalassaemiaTools for T2* image quantification. It is important that CMRtools is only used to view and analyze human cardiac and or liver images acquired with a cardiovascular magnetic resonance scanner. CMRtools must not be used to view or analyze images acquired with any other type of imaging device.
The software must not be used to view or analyze images of any part of the body except the heart and or liver or the vascular system. Furthermore, the software must not be used to view or analyze images acquired from animals.
Only DICOM images will be used for presentation, display and diagnosis.
CMRtools™ is a software package for the visualization and analysis of cardiovascular magnetic resonance images (CMR). CMRtools™ is comprised of an image loader, an image viewer and a set of optional plug-ins for specialist cardiac analysis, including VentricularTools and ThalassaemiaTools.
- VentricularTools provides dedicated functionality for calculating volume and mass indices of the . ventricles of the heart from magnetic resonance images.
- ThalassaemiaTools allows the calculation of a property called T2* that characterizes iron loading . in the heart and liver.
CMRtools™ allows high performance image manipulation, 3D visualization, and advanced image processing on a standard PC without dedicated hardware. All software plug-ins have comprehensive quantification facilities with full analysis session record for providing comprehensive audit trails.
The provided text does not contain specific acceptance criteria, study details, or performance metrics for the CMRtools and plug-ins VentricularTools & ThalassaemiaTools. The document is a 510(k) summary for pre-market notification, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies.
Therefore, I cannot populate the table or answer the questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment based on the provided text.
The text does indicate that:
- Testing was done: "CMRtools and plug-ins have been tested according to the specifications that are documented in a Software Test Plan. Testing is an integral part Cardiovascular Imaging Solutions Ltd. software development process as described in the company's Product Development Process." This confirms a testing process exists but doesn't provide details.
- Hazard analysis was performed: "The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Minor"."
Without the actual "Software Test Plan" or specific study reports, the detailed information requested cannot be extracted.
§ 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).