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The Vista ORPC with Infomatix IntraOp Software is designed to display video images while mounted on the users' head. These video images can be captured, redisplayed as still images, and exported to removable media. The ORPC with Infomatix IntraOp software is designed to be used as a personal replacement for surgical monitors.

The Vista ORPC System with IntraOp software now features the capability to control the image display with auxiliary input devices such as a touchscreen, mouse/touchpad, and a remote keypad, as well as with voice control. Color, hue, contrast and brightness for the video sources are now adjusted via the auxilliary input devices. Another new feature of the device is the capability to capture intra-operative static images of what is being displayed on the HMD. The last captured image can be displayed to the HMD as a picture-in-picture for review. The captured images can also be exported to a CD data storage disk via a CD-RW device. The capture and display last capture functions can be operated via voice control or the auxilliary input devices. The export feature is controlled via mouse, or the touchscreen. The system also allows the VGA monitor to display what is being seen in the HMD or the user interface controls on the desktop.

This document describes the 510(k) notification for the Vista ORPC with Infomatix™ IntraOp Software. However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to its image display or software functionalities.

The performance data section (Page 2 of 2) explicitly states: "The Vista Head Mounted Display System was designed and will be tested in compliance with the requirements of the following standards." This indicates that compliance testing to safety and electromagnetic compatibility (EMC) standards was planned, but no results or specific acceptance criteria for these tests or for the device's functional performance are provided.

Therefore, I cannot populate the table or answer the specific questions below from the provided text.

Here's a breakdown of why the requested information cannot be extracted:

• No performance metrics or clinical study results: The document focuses on regulatory submission details, device description, and intended use, but lacks any performance data, such as accuracy, sensitivity, specificity, image quality metrics, or any clinical outcomes.
• Emphasis on safety and EMC standards: The performance data section only lists international safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, UL2601-1) that the device will be tested against. This does not constitute specific acceptance criteria for image display or software functionality, nor does it present the results of such tests.

Based on the provided text, the following information cannot be extracted:

1. Table of acceptance criteria and reported device performance: This information is not present in the document. The document lists safety and EMC standards the device will be tested against, but provides no specific acceptance criteria for functionality or performance.
2. Sample size used for the test set and the data provenance: No test sets or study data are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No test sets or adjudication methods are mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No standalone performance study for an algorithm is mentioned as the device is a display system, not an AI algorithm for diagnosis.
7. The type of ground truth used: No ground truth is described.
8. The sample size for the training set: No training sets are mentioned.
9. How the ground truth for the training set was established: No training sets or ground truth establishment are described.

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