EyeBOX EBX-4.1

The EyeBOX EBX-4.1 is an eye-tracking device that measures and analyzes eye movements to aid in diagnosing concussion (mild traumatic brain injury) in patients ages 5-67 within one week of head injury. It uses infrared cameras to track eye position at 500 frames per second while the patient watches a video stimulus, then automatically generates a BOX score and additional eye-tracking metrics compared to a normative database of healthy individuals.

The EyeBOX EBX-4.1 has identical hardware to the predicate EBX-4.0 model and uses the same BOX score algorithm. Key differences include: additional eye-tracking and pupillometry metrics (pupil size, blink rate, disconjugacy, path departure, saccades); inclusion of a reference database of healthy subjects; display of 'Not Computed' for spurious values; and upgrades to third-party software to remove cybersecurity vulnerabilities. All devices use 850 nm infrared illumination, 500 fps eye tracking, and corneal reflection-based gaze measurement.

EN62471 Photobiological Safety of Lamps and Lamp Systems is cited as a standard with which the device complies. Not stated in this summary: specific references to ASTM, ISO, or IEC test methods for the eye-tracking accuracy, precision, or algorithm validation.

The device has the same intended use, principle of operation, and core technological characteristics (eye-tracking hardware, BOX score algorithm, stimulus presentation method) as the predicate EBX-4.0. The additional eye-tracking metrics are provided for contextual clinical information only and do not aid in diagnosis. Performance testing including accuracy, precision, and test-retest reliability demonstrates that these added metrics do not adversely impact device performance or raise new safety/effectiveness questions. Therefore, the changes do not constitute a fundamental alteration of the device's safety or effectiveness profile.