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AZE VirtualPlace - MR Flow Analysis software option for use with AZE VirtualPlace workstation is intended for post-processing of DICOM compliant velocity-encoded MRI imaging data for visualization and quantitative analysis of arterial vessels and heart valves. The MR Flow Analysis software calculates and displays the following parameters: mean/minimum/maximum and standard deviation of blood velocity in the selected region of interest (ROI); velocity and volume flow as function of time; stroke volume and cardiac output, and provides graphs of the velocity and volume. These parameters may be useful for a trained physician in supporting the determination of a diagnosis.

AZE VirtualPlace - MR Flow Analysis software is an optional post-processing software designed to be installed on and used with AZE VirtualPlace workstation (cleared under K060453), which accepts, transfers, displays, stores, and digitally process DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or from image archives) for viewing, image manipulation, communication, printing and quantification. The MR Flow Analysis retrieves velocity-encoded MRI imaging data via electric media (offline), such as CD-ROM, or digital network (online), and facilitates the visualization and quantitative analysis for arterial vessels and heart valves. The MR Flow Analysis enables to calculate blood flow velocity and flow volume in region(s) of interest (ROI[s]) from the velocity-encoded MR data, and provide quantitative and visual analysis by displaying graphical parameters such as Mean/Minimum/Maximum velocity, Standard deviation, Velocity and volume flow as function of time, Stroke volume, and Cardiac output.

This document describes the AZE VirtualPlace - MR Flow Analysis software, which is intended for post-processing DICOM compliant velocity-encoded MRI imaging data for visualization and quantitative analysis of arterial vessels and heart valves.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states "the same set of test images" was used for quantitative validation. However, the number of images in this test set is not specified.
• Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only mentions "velocity-encoded MRI imaging data via electric media (offline), such as CD-ROM, or digital network (online)".

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

• Number of Experts: The document does not specify the number of experts used.
• Qualifications of Experts: The document does not specify the qualifications of any experts involved in establishing ground truth. The comparison was made against a predicate device's output, not necessarily an expert's assessment.

4. Adjudication Method for the Test Set

• Adjudication Method: The document does not describe an adjudication method for establishing ground truth, as the comparison was primarily against the output of a predicate device.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported. The study focused on the standalone performance of the algorithm compared to a predicate device, not on human reader performance with or without AI assistance.
• Effect Size: As no MRMC study was conducted, there is no reported effect size for human reader improvement with AI assistance.

6. Standalone Performance Study

• Standalone Study: Yes, a standalone performance study was done. The document states: "the AZE VirtualPlace - MR Flow Analysis software was quantitatively validated by comparing its output to that of one of the predicate devices (cmr42 Cardiac MR Software) for the same set of test images." This is a standalone evaluation of the algorithm's output against a recognized standard (the predicate device). No human-in-the-loop performance evaluation is described.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the performance study was the output of a predicate device (cmr42 Cardiac MR Software). This implies that the predicate device's calculations and visualizations were considered the reference truth for comparison.

8. Sample Size for the Training Set

• Sample Size for Training Set: The document does not specify a training set or its sample size. This type of software, performing quantitative analysis of existing MRI data, might not necessarily involve a machine learning model that requires a distinct "training set" in the conventional sense. The "performance data" describes validation against a predicate, not model training.

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

• Ground Truth for Training Set: As no training set is described, information on how its ground truth was established is not provided.

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