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AZE Phoenix software is intended as a radiological review station and for comparison of medical images from multiple imaging modalities and/or time-points. When interpreted by a trained radiologist the images displayed in Phoenix may be used as a basis for diagnosis. AZE Phoenix supports review and comparison by collecting all image data associated with a patient from disparate data servers, modalities, and time-points in a patient centric data list. Users select images from the patient data list for qualitative visual inspection of individual study images and comparison of aligned side-by-side studies or fused visualizations. Users can also make quantitative anatomical measurements in the images including RECIST guideline measurements and save measurements to track changes over time in graphical plots. After selection and comparison of time-series images, individual images may be loaded into AZE VirtualPlaceTM workstation which is launched directly from Phoenix for series specific analysis. In summary, Phoenix enables medical image inspection and diagnosis along with qualitative and quantitative comparison of patient images over time followed by in depth analysis in AZE VirtualPlaceTM workstation.

AZE Phoenix is not indicated for mammography use. 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.

AZE Phoenix is a distributed client-server radiological review station that allows easy selection, review, processing and time-series comparison of multi-modality DICOM-compliant radiological images of patients. The AZE Phoenix software accepts, transfers, displays, stores, and digitally processes DICOM medical images from a variety of diagnostic imaging systems (such as CT, MRI, or image archives) for viewing image manipulation, communication, printing, and quantification. AZE Phoenix queries, retrieves, and sends DICOM compliant radiological images of patients to and from any number of DICOM Picture Archiving and Communication Systems (PACS) images sources. Phoenix collects all retrieved image series from all time-points and imaging modalities associated with a patient in a single patient centric list. Phoenix capabilities include: side-by-side and fusion image display; two-dimensional length, size, and angle measurements; Response Evaluation Criteria in Solid Tumors (RECIST) guideline measurements; image alignment by registration; tagging images to rapidly query and display image; customizable hanging protocol display layouts; and the ability to push specific image series to AZE VirtualPlace™ workstation (cleared under K060453) for in depth series specific analysis.

The AZE Phoenix device is a radiological review station for the comparison of medical images. The submission provided does not contain explicit acceptance criteria or a detailed study report with specific performance metrics against those criteria. Instead, it demonstrates substantial equivalence to predicate devices primarily through a comparison of technological characteristics and a general statement of measurement validation.

Here's an analysis of the provided information, framed to answer the requested points:

AZE Phoenix Device: Analysis of Acceptance Criteria and Performance

1. Table of Acceptance Criteria and Reported Device Performance

As no explicit acceptance criteria are defined in terms of quantitative performance metrics, the "acceptance criteria" can be inferred from the validation tests described and the "reported device performance" is the statement of no significant differences or improvement observed.

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

• Sample Size: Not explicitly stated. The submission mentions "CD ROM phantom CT images, clinical CT and MRI images" for measurement validation and "human breath cycle CT time series images" for alignment validation. No specific number of cases or images is provided for these test sets.
• Data Provenance: Not explicitly stated. The data is described as "CD ROM phantom CT images" and "clinical CT and MRI images" which are generic descriptions. No information on the country of origin of the data or whether it was retrospective or prospective is provided.

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

Not explicitly stated. The submission does not detail the process of establishing ground truth for the validation tests or the number and qualifications of experts involved.

4. Adjudication Method for the Test Set

Not explicitly stated. Given the comparison of measurements against a predicate device and registration methods, it's implied that the "ground truth" for comparison was either derived from the predicate device's output or established by a defined reference method, but no specific adjudication process (e.g., 2+1, 3+1) is mentioned.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described or mentioned in the provided text. The performance testing focuses on technical validation and comparison to a predicate device's measurements, not on the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was conducted. The "Performance Testing (Bench)" describes validation of the device's measurement capabilities ("geometric measurements, intensity measurements and free drawing RECIST measurements") and image alignment independent of human interpretation as the primary outcome. These tests compare the device's output directly to known values (phantoms) or the output of a predicate device.

7. The Type of Ground Truth Used

The types of ground truth used can be inferred as:

• Reference Measurements/Calculations: For "geometric measurements, intensity measurements and free drawing RECIST measurements," the ground truth likely came from:
  • Phantom data: For the "CD ROM phantom CT images," the ground truth would be the known, precisely defined dimensions and properties within the phantom.
  • Predicate device output: For "clinical CT and MRI images comparing subject and predicate (VirtualPlace) geometric measurements, intensity measurements and free drawing RECIST measurements," the predicate device's measurements likely served as the reference for comparison, indicating "no significant differences" if the results were within acceptable variability.
• Reference Registration Methods: For "Alignment and fusion image display validation using human breath cycle CT time series images," the "full registration to liver target registration" suggests a specialized, likely more accurate, registration method or expert-derived target registration as the reference ground truth for evaluating the device's alignment improvement.

8. The Sample Size for the Training Set

Not applicable. The AZE Phoenix device described here is a radiological review station with image processing capabilities, not an AI/ML-based algorithm that typically requires a distinct training set. The submission does not mention any machine learning components that would necessitate a training set. The "validation" performed is for the accuracy and functionality of its measurement and display tools.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned or implied.

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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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