RightEye Vision System

The RightEye Vision System is designed for the objective recording, viewing, and analysis of human eye movements using a dedicated hardware eye tracker and proprietary software, aiming to support clinicians in identifying visual tracking impairments. By providing quantitative metrics and graphical data on oculomotor functions, this nystagmograph system serves as a tool to supplement clinical decision-making rather than offering a standalone diagnosis.

The RightEye Vision System is a medical device intended for recording, viewing, and analyzing eye movements to support the identification of visual tracking impairment in human subjects. It utilizes a specific hardware setup, the Tobii Dynavox i15, which incorporates a remote camera and light source to record eye movements (including fixation, pursuit, and saccade) as an individual follows stimuli presented on a monitor. The system is designed to detect involuntary eye movement behavior and provide objective metrics from these measurements, capturing details not always observable through standard clinical observation, encompassing both horizontal and vertical eye movements. Data acquired by the RightEye Vision System is encrypted using HTTPS protocol and transferred to a remote web server for storage and analysis. Proprietary software algorithms on this server calculate metrics from the assessment data, generating quantitative outputs, supporting graphics, trendlines, and gaze replay features. Clinicians access these results via a dedicated web portal, optimized for Chrome and running on Windows 10 operating systems. This allows for tracking changes over time and is intended to supplement and inform clinical decision-making without providing a direct diagnosis. The system has undergone software validation and verification, as well as validation testing for test-retest reliability and accuracy, to confirm its performance for its intended use.

AI Regulatory Concerns

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• Q1. What specific quantitative metrics does the RightEye Vision System provide, and how are these metrics benchmarked or compared to normative data, if at all?; How does the system's analysis of involuntary and voluntary eye movements differentiate between various potential causes or types of visual tracking impairments?; What are the documented sensitivity and specificity of the RightEye Vision System in identifying visual tracking impairments when compared to traditional clinical evaluation techniques?; Could you elaborate on the test-retest reliability and accuracy validation studies, specifically the populations tested and the conditions under which these were established?; Are there any specific patient populations (e.g., pediatric, geriatric, individuals with certain neurological conditions) for whom the system's performance might be different or require specific calibration?