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MR-CT VVA is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels for use on individual patients with cardiovascular disease. Further, MR-CT VVA allows the quantification of T2* in MR images of the heart and the liver. Finally, MR-CT VVA can be used for the quantification of cerebral spinal fluid in MR velocity-encoded flow images.

When the quantified results provided by MR-CT VVA are used in a clinical setting on MR and CT images of an individual patient, they can be used to support the clinical decision making for the diagnosis of the patient. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.

MR-CT VVA (MR-CT Vessel and Ventricular Analysis) is image post-processing software for the viewing and quantification of MR and CT images of blood vessels, of the heart and MR images of the liver and cerebral spinal fluid. Semi-automatic contour detection forms the basis for the analyses. Its functionality is independent of the type of vendor acquisition equipment. The analysis results are available on screen and can be exported in various electronic formats.

MR-CT VVA has been developed as a standalone application to run on a Windows based operating system. The import of images and the export of analysis results are via CD / DVD, a PACS or network environment.

MR-CT VVA has a modular structure that consists of its previously cleared predicate devices: MRI-MASS, CT-MASS, MRI-FLOW, CMS-VIEW and MRA-CMS. MR-CT VVA comprises their respective functionalities for analyzing the blood vessels and the heart. In addition, MR-CT VVA includes new functionality for the 3D review of MR volumetric data.

The provided text does not contain detailed information about specific acceptance criteria and the results of a study proving the device meets those criteria. It primarily focuses on the regulatory submission process and the substantial equivalence to predicate devices.

However, I can extract information related to the device description, intended use, and general statement about testing and validation.

Here's an attempt to answer your request based on the available text, with caveats for missing information:

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

The document does not explicitly list specific acceptance criteria in a table format nor does it provide a table of reported device performance metrics against those criteria. It broadly states that "Testing and validation have produced results consistent with design input requirements."

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

The document does not provide details on the sample size used for the test set, the country of origin of the data, or whether it was retrospective or prospective.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. The device is described as providing "more reproducible than manually derived quantified results," implying an improvement over manual methods, but no study details are given.

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

The document states: "MR-CT VVA has been developed as a standalone application to run on a Windows based operating system." This confirms that a standalone algorithm is at the core of the device. However, regarding performance, it also mentions that analysis results are based on "contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing." This indicates that while the software has standalone capabilities for automatic detection, it's designed to be used with human review and potential editing, implying a human-in-the-loop component in its typical clinical use. Standalone performance data (algorithm only) is not provided.

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

The document does not specify the type of ground truth used for testing or validation.

8. The sample size for the training set

The document does not provide information about the sample size used 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.

Summary of available information related to performance and validation:

The document states:

• Device Description: "Semi-automatic contour detection forms the basis for the analyses."
• Intended Use: "These analyses are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing."
• Indications for Use: "MR-CT VVA is indicated for use in clinical settings where more reproducible than manually derived quantified results are needed to support the visualization and analysis of MR and CT images of the heart and blood vessels..."
• Conclusions: "Testing and validation have produced results consistent with design input requirements. MR-CT VVA is a software-only device for which there no applicable mandatory performance standards." And "Medis concludes that MR-CT VVA is a safe and effective medical device, and is at least as safe and effective as its predicate devices."

In essence, the submission asserts that the device is safe, effective, and meets its design requirements, partly evidenced by its "more reproducible than manually derived quantified results." However, the specific study details (methodology, sample sizes, ground truth establishment, expert qualifications, and quantitative performance metrics against acceptance criteria) that would prove these claims are not present in the provided text. The submission relies heavily on demonstrating substantial equivalence to predicate devices rather than providing detailed de novo performance study results.

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