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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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AZE VirtualPlace is an image processing workstation that accepts, transfers, displays, stores, and digitally processes 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. When interpreted by a trained physician, filmed or displayed images on the VirtualPlace monitor may be used as a basis for diagnosis, except in the case of mammography images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

The AZE VirtualPlace utilizes DICOM images as it facilitates reviewing, printing, storing, communications, and transferring multi-modality images from a variety of diagnostic imaging systems, such as CT, MR. The AZE VirtualPlace consists of workstation, monitor, keyboard and mouse. The AZE VirtualPlace is provided as basic software with additional software modules available for various features/functions.

The provided text is a 510(k) Premarket Notification for the AZE VirtualPlace device. It details the device's description, intended use, and substantial equivalence to predicate devices, but does not contain any information regarding specific acceptance criteria for performance, a study proving it meets such criteria, or any of the detailed performance data requested in your prompt.

Here's why the requested information cannot be extracted from this document:

• Nature of the 510(k) Submission: A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This often involves comparing technological characteristics, intended use, and safety/effectiveness claims without necessarily requiring new clinical trials or detailed performance studies against specific acceptance criteria for the new device.
• "Performance Data (non-clinical or clinical)" Section: The document explicitly states: "The AZE VirtualPlace is substantially equivalent to the predicate devices based on the descriptive data, compliance with standards, software features and indications for use." It does not present any empirical performance data.
• Focus on Standards Compliance: The "Technological Characteristics" section lists compliance with various standards (IEC 60950, IEC 60601-1-2, EN 55022, DICOM, JPEG). This is about meeting recognized technical and safety standards, not about specific clinical performance metrics.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies because this information is not present in the provided text. The document's conclusion simply states that "The technological characteristics and performance data for the AZE VirtualPlace demonstrates it is substantially equivalent to the predicate devices," implying that explicit new performance criteria and studies were not required for this particular submission.

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