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The RightEye Vision System is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.

RightEye Vision System detects involuntary eye movement behavior for the purpose of visual tracking. The RightEye Vision System is designed to provide accurate and reliable information for users to supplement and inform clinical decision-making. RightEye Vision System provides objective metrics acquired from eve movements measured and recorded by a hardware eye tracker that are not observable in clinical observation. Results of each RightEye Vision System assessment are transferred and stored remotely on a web server. All personal health information data are encrypted with HTTPS (HTTP Secure) protocol. The remote web server software calculates metrics from the assessment data and provides quantitative outputs and supporting graphics. The software can track the results over time showing changes in metrics, trendlines, graphs, visuals, and qaze replay. The user accesses these results by logging into the RightEye web portal.

The RightEye Vision System is designed to run on Windows 10 operating systems and the web portal has been optimized for Chrome. RightEye Vision System is programmed to run on a specific hardware setup, the Tobii Dynavox i15. It is deployed as a pre-loaded system on hardware provided and managed by RightEye.

The provided text does not contain detailed acceptance criteria and a study to prove the device meets these criteria in the format requested.

The document is a 510(k) premarket notification summary for the RightEye Vision System, which focuses on demonstrating substantial equivalence to a predicate device (EYE-SYNC K152915).

While it mentions that "Validation testing, including test-retest reliability and accuracy, has confirmed the performance of the RightEye Vision System for its intended use," it does not provide specific acceptance criteria, reported performance metrics, sample sizes, provenance, details about human experts, adjudication methods, or effects of AI assistance.

The information provided about "Supporting Information" and "Conclusion" is general and summarizes that software testing was conducted and performance was confirmed, but it does not detail how that performance was measured against specific, quantifiable acceptance criteria.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

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