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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:

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• Delineate the inner and outer wall of the ventricles automatically, semi-automatically or manually, as well as the papillary muscles, on different kinds of MRI images.
• Derive from these images and contours quantitative information to be used to assist in cardiac analysis
  The CAAS MRV has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as for research purposes like clinical research trials.

The CAAS MRV is a software tool designed for the functional analysis of the heart based on multi-slice, multi-phase MR images of the heart. Therefore it provides functionality to import and view cine MR datasets of the heart from several vendors from CDROM, hard disk or (optionally) a PACS system. Next, the inner and outer wall of the ventricles can be determined either automatically, semi-automatically or manually. From these contours the ventricular volume, the ejection fraction and other related parameters are determined. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall is quantified. All results of the analysis are available on screen as well as hardcopy, and can be saved.

This 510(k) summary does not contain the detailed acceptance criteria or a study demonstrating the device meets such criteria. It focuses on establishing substantial equivalence to a predicate device and describing the intended use and technological characteristics.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence rather than presenting specific performance study results against defined acceptance criteria.

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The CAAS MRV has been designed for quantitative functional analysis of the left and right ventricle of the heart based on multi-slice, multi-phase cine MRI images. Specifically, it enables the user to: 1. Delineate automatically or semi-automatically the inner and outer wall of the ventricles, as well as the papillary muscles, on the MRI images 2. Derive from these contours the global and regional functional parameters like Ejection Fraction, Stroke Volume, Wall Movement etc. The CAAS MRV has been designed to be used in everyday clinical practice, as well as for research purposes like clinical research trials.

The CAAS MRV is a software tool designed for the functional analysis of the heart based on multi-slice, multi-phase MR images of the heart. Therefore it provides functionality to import and view cine MR datasets of the heart from several vendors from CDROM, hard disk or (optionally) a PACS system. Next, the inner and outer wall of the ventricles can be determined either automatically, semi-automatically or manually. From these contours the ventricular volume, the ejection fraction and other related parameters are determined. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall is quantified. All results of the analysis are available on screen as well as hardcopy, and can be saved.

The provided text describes the CAAS MRV software package, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria, specific study designs, or performance metrics.

The document is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical validation study.

Based on the available information, here's what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in the document as quantitative criteria with thresholds. The key "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to a predicate device.

• Reported Device Performance: The document states that "CAAS MRV is substantially equivalent to the quantitative analysis software package MRI-Magnetic resonance Analytical Software System, K994283." It also mentions that the CAAS MRV "is substantially equivalent to the predicate device mentioned in this summary by using the same technological characteristics and intended use."

  Acceptance Criteria (Inferred from 510(k))	Reported Device Performance
  Substantial equivalence to predicate device (K994283) in technological characteristics and intended use	CAAS MRV found substantially equivalent to predicate device
  Ability to delineate inner/outer ventricle walls and papillary muscles (auto/semi-auto)	Device provides functionality to "determine" inner and outer wall and papillary muscles (auto/semi-auto/manual)
  Ability to derive global/regional functional parameters (EF, SV, Wall Movement)	Device determines ventricular volume, ejection fraction, and other related parameters; quantifies wall motion

  Missing:

  • Specific quantitative performance metrics (e.g., accuracy, precision, inter-observer variability, intra-observer variability) for measurements like Ejection Fraction, Stroke Volume, Wall Movement compared to a gold standard or the predicate device.
  • Defined thresholds for these metrics (e.g., "Ejection Fraction measurement will be within X% of the true value").

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Missing: The document does not provide any information about a specific test set, its sample size, or data provenance. This level of detail is typically part of a separate validation report, not the 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Missing: This information is not provided. The document does not describe the establishment of a ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Missing: This information is not provided.

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 evidence: The document does not mention a multi-reader, multi-case comparative effectiveness study. The focus is on the device's inherent capabilities and its equivalence to a predicate, not on human-with-AI vs. human-without-AI performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Implied primary function: The device's description highlights its ability to "determine" ventricular parameters "either automatically, semi-automatically or manually." This suggests that a standalone (automatic algorithm only) performance would be a component of its functionality. However, specific standalone performance metrics from a study are not reported in this document. The 510(k) emphasizes its use by a user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Missing: This information is not provided. Given that the device analyzes MRI images, a likely ground truth would involve expert manual contouring and calculation, but this is speculative based on the document.

8. The sample size for the training set:

• Missing: This information is not provided. The document does not discuss training data for the algorithms.

9. How the ground truth for the training set was established:

• Missing: This information is not provided.

In summary:

This 510(k) submission primarily demonstrates that CAAS MRV is "substantially equivalent" to an already marketed device (MRI-Magnetic resonance Analytical Software System, K994283) in terms of its intended use and technological characteristics. It outlines the device's functions (automatic/semi-automatic/manual delineation, calculation of parameters like EF, SV, wall movement) but does not provide the detailed validation study results, specific acceptance criteria with quantitative thresholds, sample sizes for test/training sets, ground truth establishment methods, or expert qualifications that you requested. These details would typically be found in a more comprehensive technical report or validation study that underpins such a submission, but are not included in the provided 510(k) summary or FDA clearance letter.

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