Search Results

The Vista Head Mounted Display System is designed to display video images while mounted on the users head.

The Head Mounted Display (HMD) System is a binocular field display, occupying a large portion of the normal straight ahead field of view. This display is intended to be used as a component of a visualization system for use in endoscopic surgery. Traditional video-endoscopic surgery images are displayed on a TV monitor. This requires the surgeon to maintain contact with the traditional monitor and remain in position with it at all times. Having to turn away from the monitor causes the surgeon to lose sight of what is being accessed. The HMD system enables the surgeon to see the surgical site as well as the general operating field with the lateral and 45 degree look down vision, without having to look away, thus providing the means to present the endoscopic picture in a more natural and acceptable look down location with respect to the patient. This also provides a safe back up, the physician can resort to either direct visualization or utilize the back up 2D video monitor. The HMD takes a standard signal and displays it on two small electronic image display devices called liquid crystal display (LCD). It can be connected to any standard video generating equipment.

The HMD consists of an image generating array, evepiece, and electronics. The image generating array is an active matrix liquid crystal display (LCD). These elements are mounted on a lightweight and compact headgear which fits comfortably on the user's head. The remaining electronics are housed separately in a controller station. The HMD communicates with the controller by a lightweight, durable, flexible cable. The HMD can be driven by both monocular and stereo endoscopes.

The HMD Controller will accept NTSC, PAL with CVBS, or S Video (Y,C) video input. Interfaces to external and remote data sets, power supplies and drivers for the LCD and backlight are included in the controller. A maximum of four (4) HMDs and two (2) standard video monitors can be driven simultaneously with the single controller.

The provided text describes a medical device, the "Head Mounted Display (HMD)", and its intended use, but it does not include information about acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot populate the table or answer most of the questions you've posed. The 510(k) summary focuses on device description, intended use, and comparison to predicate devices for regulatory clearance, not on performance studies with defined acceptance criteria.

Here's what I can extract based on the provided text, and what remains unanswered:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not provided. The document does not mention any test set, sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not provided. The document does not mention any expert review or ground truth establishment for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. No test set or adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done. If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. The Head Mounted Display is a hardware component for visualization. It is not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. This is a hardware device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not provided. No performance studies or ground truth establishment are described.

8. The sample size for the training set:

• Not applicable/Not provided. The device is hardware; there is no mention of a training set for an algorithm.

9. How the ground truth for the training set was established:

• Not applicable/Not provided. There is no mention of a training set or its ground truth.

Ask a specific question about this device