(210 days)
Standalone software for medical image analysis intended for advanced visualization and quantitative analysis for diagnostic in the field of cardiology by means of segmentation of cardiovascular structures and enabling the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images as well as measurement and reporting tools by providing the following functionality:
- Segmentation of cardiovascular structures and calculation of quantitative results ●
- Support signal intensity analysis for the myocardium
- . Quantification of MR parametric maps (such as T1, T2, T2* relaxation)
- Visualization and quantification of blood flow velocity and directions
When the results provided by CAAS MR Solutions are used in a clinical setting to support diagnoses, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical decision making.
CAAS MR Solutions is an image post-processing software package which offers functionality to import DICOM MR images, to segment cardiovascular structures in these images, to visualize and evaluate blood flow in cardiovascular structures, to analyze and quantify these cardiovascular structures and to present the analysis results in different formats.
CAAS MR Solutions is designed as a stand-alone software package to run on a PC with a Windows operating system. It can read DICOM MR images from an accessible file system, hard disk (local directory), or (indirectly) received from the MR or PACS system. CAAS MR Solutions provides the functionality to import the DICOM MR images and to organize the loaded DICOM MR images into patients, studies, and series.
CAAS MR Solutions comprises functionalities for viewing and quantification of cardiovascular MR images, segmentation of cardiovascular structures and calculation of quantitative results, for signal intensity analysis of the myocardium, for quantification of MR parametric maps and for visualization of blood flow velocity and directions.
Results can be displayed on the screen, printed, or saved in a variety of formats to hard disk, network or PACS system. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats.
The provided text is a 510(k) summary for the device CAAS MR Solutions. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results with specific acceptance criteria and outcome metrics.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details (e.g., sample size, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth type, training set details) from the provided text.
The document states:
- "The verification and validation of the new strain analysis workflow demonstrated that the results meet the accuracy and reproducibility requirements."
- "Equivalence in numerical results for the analysis workflows already available in the predicate device CAAS MR Solutions (K181825) was demonstrated with regression testing."
However, it does not specify what those accuracy and reproducibility requirements are (i.e., the acceptance criteria), nor does it provide the reported device performance against those criteria in a quantitative manner. Details about the studies (e.g., sample size, ground truth establishment) are also absent.
To answer your request, a detailed performance study report would be needed, which is not part of 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).