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CAAS MRV features segmentation of cardiovascular structures on different types of MR images as well as measurement and reporting tools to facilitate the following use:

· Quantitative functional and regional analyses of the heart ventricles

· Quantification of T2 and T2* relaxation values
CAAS MRV is intended to be used by or under supervision of a cardiologist. When the results provided by CAAS MRV are used in a clinical setting to support diagnosis of cardiovascular conditions, the results assurts of critic to be regarded as the sole, irrefutable basis for clinical decision making.

CAAS MRV is designed as a stand-alone modular software package for viewing and quantification of cardiovascular MR images intended to run on a PC with a Windows operating system. The images for analysis can be read from CD, hard disk or from a PACS system and CAAS MRV provides the functionality to scan the contents of a specific directory and to organize the found DICOM MR images into patients, studies and series.

CAAS MRV contains several analysis workflows of the previously cleared predicate device CAAS MRV (K060941) for quantification of the functional and regional parameters of the heart ventricles. Contour detection performed automatically, semi-automatically or manually forms the bases for the analyses.

Functionality to quantify T2 and T2* relaxation values is added by means of the analysis module Tissue Mapping. For this specific feature, Medis MR-CT VVA is used as a predicate device. This feature is implemented in MR-CT VVA and is very similar in both control and presentation, to the CAAS MRV feature, and yields the same results.

The quantitative results of CAAS MRV support diagnosis of cardiovascular conditions.

The analysis results are available on screen and can be saved to hard-disk to enable re-analysis of the data. Also, the analysis results can be exported in various electronic formats.

The functionality is independent of the type of vendor acquisition equipment.

Acceptance Criteria and Device Performance for CAAS MRV (K162112)

Note: The provided document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to predicate devices rather than detailing extensive clinical trials with specific acceptance criteria and outcome metrics for standalone performance or comparative effectiveness. Therefore, some requested information may not be explicitly present and is inferred where possible.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria. Instead, it describes general validation approaches and claims equivalence rather than specific quantitative performance targets. The "Performance Data" section states that "the quantification of the tissue relaxation values (T2 and T2*) meet the accuracy and reproducibility requirements." However, the specific numerical requirements or the reported accuracy/reproducibility values are not disclosed in this document.

For the purpose of illustrating the expected format, if such a table were present, it might look like this:

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set. It mentions "validation of the tissue mapping algorithms" and "regression testing" for existing workflows but provides no details on the number of cases or studies involved.

The provenance of the data (country of origin, retrospective or prospective) is not disclosed in this document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document.

4. Adjudication Method for the Test Set

The adjudication method is not described in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of an MRMC comparative effectiveness study is made in this document. The submission focuses on demonstrating substantial equivalence, often through technical comparisons and non-clinical performance data, rather than measuring human reader improvement with AI assistance.

6. Standalone Performance Study

The document describes the validation of algorithms and system testing, which implies standalone performance evaluation of the algorithms. For example, "the validation of the tissue mapping algorithms... demonstrated that the quantification of the tissue relaxation values (T2 and T2*) meet the accuracy and reproducibility requirements." This suggests an assessment of the algorithm's performance without a human in the loop making interpretations. However, specific metrics (e.g., sensitivity, specificity, agreement with ground truth for segmentation or measurements) are not quantified in this summary.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated. However, given the nature of the device (segmentation, quantification, T2/T2* relaxation values), it is highly likely that:

• For functional and regional analyses of heart ventricles: Ground truth would typically be established by expert manual segmentation and measurements, or potentially by comparison to other validated imaging modalities or techniques. The mention of "regression testing... to verify equivalence in numerical results" suggests comparison against an established reference from the previous version of CAAS MRV.
• For quantification of T2 and T2 relaxation values:* Ground truth would likely involve a reference standard method for calculating T2 and T2* values, potentially derived from accepted mathematical models applied to the raw MR signal data, or comparisons to a validated quantitative imaging system.

8. Sample Size for the Training Set

The sample size for the training set is not provided in this document. Given that CAAS MRV (K060941) was a predicate, some of the algorithms may have been established prior to this submission, and the "Tissue Mapping" module might have involved a separate development and training process.

9. How the Ground Truth for the Training Set Was Established

The document does not describe how the ground truth for the training set was established. This information is typically part of the device's technical documentation but not usually included in a 510(k) summary focused on substantial equivalence.

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