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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.

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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.

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.

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