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

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The provided document is a 510(k) clearance letter from the FDA for the "Vista Head Mounted Display System". This type of document indicates regulatory clearance for a device based on substantial equivalence to a predicate device already on the market.

Crucially, this document does not contain the kind of detailed information about acceptance criteria, specific device performance studies, sample sizes, expert qualifications, or ground truth methodologies that your request asks for.

The 510(k) clearance process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It typically relies on comparative performance against the predicate, but the detailed study methodology and results (especially for AI-based performance metrics) are not usually included in the public-facing clearance letter.

Therefore, I cannot provide the requested information from the provided text. The document is too high-level and does not delve into the specifics of a performance study proving acceptance criteria for an AI device.

To answer your questions, I would need a different type of document, such as a detailed study report, a clinical trial summary, or a more comprehensive technical submission.

Ask a specific question about this device