(72 days)
cmr42 is intended to be used for viewing, post-processing and quantitative evaluation of cardiovascular magnetic resonance (MR) images in a Digital Imaging and Communications in Medicine (DICOM) Standard format. It enables:
Importing Cardiac MR Images in DICOM format
Supporting clinical diagnostics by qualitative analysis of the cardiac MR images using display functionality such as panning, windowing, zooming, navigation through series/slices and phases.
Supporting clinical diagnostics by quantitative measurement of the heart and adjacent vessels in cardiac MR images, specifically distance, area, volume and mass
Supporting clinical diagnostics by using area and volume measurements for measuring LV function and derived parameters cardiac output and cardiac index in long axis and short axis cardiac MR images.
Flow quantifications based on velocity encodes images
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cmr42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cmr42 is not restricted, however the image acquisition by a cardiac magnetic resonance scanner may limit the use of the device for certain sectors of the general public.
cmr42 shall not be used to view or analyze images of any part of the body except the cardiac magnetic resonance images acquired from a cardiovascular magnetic resonance scanner.
cmr42 is a dedicated software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. cmr42 has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac images for volume/mass, and flow quantification. It provides a comprehensive set of tools for the analysis of Cardiovascular Magnetic Resonance (CMR) images.
The provided 510(k) summary for the cmr42 Cardiac MR Software Application (K082628) describes its intended use and a general statement about testing but does not provide a detailed table of acceptance criteria or the specific results of a study proving the device meets these criteria.
Instead, the summary states:
"Description and Testing: cmr42 have been tested according to the specifications that are Conclusion of Testing documented in a Master Software Test Plan. Testing is an integral part of Circle Cardiovascular Imaging Inc software development process as described in the company's product development process."
"Conclusion: The successful non-clinical testing demonstrates the safety and effectiveness of the cm42 when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device."
This indicates that internal testing was conducted to specifications but the specific acceptance criteria and detailed performance metrics are not publicly available in this document. The submission focuses on demonstrating substantial equivalence to predicate devices (MRI-MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM (MASS) K994283 and MRI-Flow Analytical Software K994282) rather than publishing detailed performance studies against explicitly stated acceptance criteria.
Therefore, for most of the requested information, the answer is "Not provided in the given document."
Here's a breakdown of what can be extracted or inferred based on the supplied text:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Inferred from device description and comparison) | Reported Device Performance (General Statement) |
|---|---|
| Qualitative Analysis: |
- Viewing, panning, windowing, zooming
- Navigation through series/slices and phases | Demonstrated safety and effectiveness for qualitative analysis. |
| Quantitative Measurements: - Distance, area, volume, mass of heart and adjacent vessels
- LV function, cardiac output, cardiac index from long and short axis images | Demonstrated safety and effectiveness for quantitative measurements; performs "as well as or better than" predicate devices. |
| Flow Quantifications: - Based on velocity encoded images | Demonstrated safety and effectiveness for flow quantifications; performs "as well as or better than" predicate devices. |
| Image Compatibility: - Import DICOM-format Cardiac MR Images
- Images from all MRI scanner vendors supported | Functionality confirmed. |
| User Interface and Functionality: - Graphical user interface
- Comprehensive tool sets
- Dynamic display of ventricular contractions
- DICOM compliant networking
- Reports with visualization and quantitative parameters | Functionality confirmed and described as having "task specific modules with corresponding tool sets." |
| General Performance: - Safety and Effectiveness | Non-clinical testing demonstrates safety and effectiveness. Performs "as well as or better than" the legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the given document. The document only mentions "non-clinical testing" and testing "according to the specifications that are documented in a Master Software Test Plan." Specifics about the test set, its size, or its provenance are not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not provided in the given document. The document does not describe the methodologies for establishing ground truth or the involvement of experts in the testing phase. The device itself is intended for use by "qualified medical professionals, experienced in examining and evaluating cardiovascular MR images."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided in the given document. No information on adjudication methods for establishing ground truth or evaluating test results is given.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study is not mentioned as part of this 510(k) submission. The submission focuses on the standalone performance of the software in comparison to predicate devices, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone evaluation was implicitly done. The "cmr42" is described as a "software application" for viewing, post-processing, and quantitative evaluation. The testing described is "non-clinical testing" to demonstrate its safety and effectiveness and that it performs as well as or better than predicate devices. This implies evaluating the software's performance on its own capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated in the given document. Since the device performs quantitative measurements (distance, area, volume, mass), the ground truth for testing would likely involve highly accurate reference measurements, possibly derived from manual expert measurements, phantoms, or other validated methods. However, the specific type of ground truth is not detailed.
8. The sample size for the training set:
- Not applicable / Not provided. The cmr42 is described as an "Image Processing System" and "software application" for analysis. At the time of this 2008 submission, the focus for such devices was primarily on deterministic algorithms and user-driven analysis tools rather than AI/machine learning models that require distinct training sets. Therefore, a "training set" in the modern AI sense is unlikely to have been a component of its development or evaluation, and no such information is provided.
9. How the ground truth for the training set was established:
- Not applicable. As a training set is not mentioned, the method for establishing its ground truth is also not provided.
§ 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).