(148 days)
CAAS MR Solutions is a modular software product intended to be used by or under supervision of a cardiologist or radiologist in order to aid in reading and interpreting cardiovascular MR images and to visualize and evaluate blood flow in cardiovascular structures to support clinical decision making.
CAAS MR Solutions features segmentation of cardiovascular structures, enables 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 found DICOM MR images into patients, studies and series.
CAAS MR Solutions is composed out of analysis workflows of its previously cleared devices: CAAS MRV, CAAS MR Flow and CAAS MR 4D Flow. CAAS MR Solutions comprises their respective functionalities for viewing and quantification of cardiovascular MR images. In addition, CAAS MR Solutions offers new functionality for signal intensity analysis of the myocardium and for MR parametric maps for T1 relaxation. The CAAS MR Solutions product has a moderate level of concern.
Results can be displayed on the screen, printed or saved in a variety of formats to hard disk, network, PACS system or CD. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats.
Pie Medical Imaging B.V.'s CAAS MR Solutions is a software package for post-processing medical images. This 510(k) summary provides details about its acceptance criteria and the studies conducted to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA summary does not provide a specific table of acceptance criteria with numerical targets. Instead, it states that the device was validated to meet "accuracy and reproducibility requirements" for new functionalities and that "equivalence in numerical results" was demonstrated for existing functionalities.
Therefore, the table below reflects what can be inferred from the provided text, focusing on the categorical nature of the reported performance rather than specific numerical metrics.
| Functionality Category | Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| For new functionalities (Signal Intensity Analysis, T1 Mapping): | Results meet accuracy and reproducibility requirements. | The validation demonstrated that the results meet the accuracy and reproducibility requirements. |
| For functionalities available in predicate devices (segmentation, flow analysis): | Equivalence in numerical results compared to predicate devices. | Equivalence in numerical results for the analysis workflows already available in the predicate devices CAAS MRV, CAAS MR Flow and CAAS MR 4D Flow was demonstrated with regression testing. |
| Overall System Requirements: | System requirements derived from intended use and indications for use, as well as risk control measures, are implemented correctly, and the device meets specifications. | Verification and validation of the CAAS MR Solutions showed that the system requirements were implemented correctly and that the device meets its specifications. |
| Usability: | User is able to use CAAS MR Solutions for its developed purpose. | Usability testing in accordance with IEC62366 demonstrated that the user is able to use CAAS MR Solutions for the purpose it was developed for. |
| Safety and Effectiveness: | As safe and effective as its predicate devices. | CAAS MR Solutions can be considered as safe and effective as its predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "validation" and "testing" without providing specific dataset details.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts used to establish ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size related to human reader improvement with or without AI assistance. The focus of this submission is on demonstrating substantial equivalence to predicate devices and meeting internal specifications, not on comparative effectiveness with human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document indicates that the device has standalone functionalities. For example, it states "The validation of the new functionalities for signal intensity analysis workflow and the T1 mapping quantification demonstrated that the results meet the accuracy and reproducibility requirements." This implies that the algorithm's performance on these specific tasks was assessed independently. However, the overall intended use is for aiding a cardiologist or radiologist, implying a human-in-the-loop context for clinical decision-making.
7. The Type of Ground Truth Used
The document does not explicitly state the specific type of "ground truth" used for validation. However, considering the nature of the device (segmentation, quantification of parameters like T1, T2, T2* relaxation, blood flow), it is highly probable that the ground truth for new functionalities would involve:
- Reference standard measurements: Comparison against established reference methods or expert manual measurements for parameters like T1 mapping and signal intensity analysis.
- Clinical consensus: For segmentation tasks, expert consensus on manual or semi-manual delineations would likely serve as a ground truth.
For the functionalities already available in predicate devices, the "equivalence in numerical results" implies comparison against outputs from those already validated predicate devices rather than a direct independent ground truth assessment.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established. Given that the device incorporates functionalities from previously cleared devices (CAAS MRV, CAAS MR Flow, CAAS MR 4D Flow), it's possible that some methodologies for establishing ground truth for training data were inherited or adapted from those previous developments. However, this is not detailed in the provided text.
§ 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).