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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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