(106 days)
CAAS MR 4D Flow is a software product intended to be used by or under supervision of a cardiologist or radiologist in order to visualize and evaluate blood flow in cardiovascular structures based on multi-slice, multi-phase and velocity encoded MR images to support clinical decision making.
CAAS MR 4D Flow enables the analysis of blood flow in the heart and large vessels based on multi-slice, multi-phase and velocity encoded MR images by providing the following functionality:
Segmentation of cardiovascular structures;
Visualization of blood flow velocity and directions;
Calculation of quantitative cardiovascular results.
When the results provided by CAAS MR 4D Flow 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 4D Flow offers functionality to import images; to analyze the behavior of blood flow in vessels and through heart valves in phase-contrast MR (Flow) images semi-automaticative flow analysis on the images, and to present the analysis results in different formats.
The CAAS MR 4D Flow software 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 (CD) and CAAS MR 4D Flow provides the functionality to scan the contents of a specific directory and to organize the found DICOM MR images into patients, studies and logical imagesets.
A phase-contrast MR imageset is necessary for performing 4D Flow analysis. Depending on the specific analysis goals, one or more MR imagesets may be added for reference purposes (phase contrast or cine imagesets).
After the MR images are read, the CAAS MR 4D Flow software provides functionality to perform the following measurements:
- . Extraction (and, if wanted, manual editing) of a 3D mesh of the vessel lumen, based on user input points.
- Visualization of color-coded 3D blood motion vectors originating from one or more user-defined planes in the cardiovascular structure.
- Visualization of color-coded (fixed) streamlines and (animated) pathlines indicating blood movement pattern originating from one or more user-defined planes in the cardiovascular structure.
- Visualization and quantification of blood flow through a pre-defined plane.
Methods to automatically correct for image artifacts or user errors like aliasing, eddy-currents, movement offset, or incorrect velocity direction indication, are available.
The results of the analysis will be generated as visual snapshots or animation of 3D blood motion (see above) or quantifications, for example: - Flow through a plane over time (forward, backward, total)
- Min, max, mean, average, sdev velocity through a plane over time
- Pulse wave velocity over a segment of the vessel
Results can be displayed in numerical format or (if applicable) as graphs. An analysis can be saved to hard disk to enable re-analysis of the data. Visual results can be exported as animation or bitmap images. A graphic report can be exported in DICOM or PDF format, containing both numerical and also be printed. Numerical results can be exported as text files.
The provided text is a 510(k) summary for the CAAS MR 4D Flow device. It outlines the device's intended use, indications for use, and a comparison to a predicate device (Morpheus HeartScan, K133937) to demonstrate substantial equivalence. However, it does not contain a detailed study report with specific acceptance criteria and performance data for the CAAS MR 4D Flow device itself, nor does it describe sample sizes, ground truth establishment, or human reader effectiveness studies.
Instead, the document states: "Verification and validation of the CAAS MR 4D Flow functionality showed that the system requirements – derived from the intended use and indications for use – as well as risk control measures were implemented correctly and that the device meets its specifications including conformance to the following standards: ISO 14971:2007, Medical devices Application of risk management to medical devices; NEMA PS 3.1 3.20 (2011), Digital Imaging and Communication in Medicine (DICOM); IEC 62304 First edition 2006-05, Medical device software Software life cycle processes; IEC 62336:2007, Medical devices Application of usability engineering to medical devices. The verification and validation results demonstrate the safety and effectiveness of CAAS MR 4D Flow in relation to its intended use and therefore CAAS MR 4D Flow can be considered as safe and effective as its predicate device."
This statement indicates that performance testing was conducted to meet system requirements and relevant standards, but the specifics of those tests, including quantitative acceptance criteria and reported device performance metrics, are not included in this summary. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a standalone performance study.
Therefore, I cannot populate the requested table and answer many of the specific questions about acceptance criteria and study details based solely on the provided text. The information is simply not present here.
Based on the provided text, here's what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Quantifiable acceptance criteria for specific functionalities (e.g., segmentation accuracy, flow quantification accuracy) | NOT SPECIFIED IN DOCUMENT |
| Conformance to ISO 14971:2007 (Risk Management) | Stated that risk control measures were implemented correctly. |
| Conformance to NEMA PS 3.1-3.20 (2011) (DICOM) | Stated that the device meets its specifications, including DICOM conformance. |
| Conformance to IEC 62304:2006-05 (Medical Device Software Life Cycle) | Stated that the device meets its specifications, including IEC 62304 conformance. |
| Conformance to IEC 62336:2007 (Usability Engineering) | Stated that the device meets its specifications, including IEC 62336 conformance. |
| Clinical performance metrics (e.g., sensitivity, specificity, accuracy for specific clinical endpoints) | NOT SPECIFIED IN DOCUMENT |
2. Sample size used for the test set and data provenance:
- Not specified in the document. The document states "Verification and validation of the CAAS MR 4D Flow functionality showed that the system requirements... were implemented correctly and that the device meets its specifications," but no details about the data used for this testing are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified in the document.
4. Adjudication method for the test set:
- Not specified in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- Not specified in the document. The document does not describe any human-in-the-loop studies or comparative effectiveness studies involving human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The nature of the "Verification and validation" mentioned suggests standalone testing of the software's functionality, but no specific performance results (e.g., accuracy, precision) are provided. The focus is on meeting system requirements and standards, not on clinical performance metrics typically associated with standalone algorithms like diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the document.
8. The sample size for the training set:
- Not applicable / not specified. The document describes a software product for analysis and visualization, implying it might be rule-based or model-based, but does not explicitly mention a "training set" in the context of machine learning. If it does use machine learning components (e.g., for segmentation), details about training data are not provided.
9. How the ground truth for the training set was established:
- Not applicable / not specified. (See point 8)
§ 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).