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The EYE-SYNC® is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects. The EYE-SYNC® is intended to record, measure, and analyze eye movements as an aid in the diagnosis of concussion, also known as mild traumatic brain injury (mTBI), within three days of sport-related head injury in patients 17-24 years of age in conjunction with a standard neurological assessment, for use by medical professionals qualified to interpret the results of a concussion assessment examination. A negative EYE-SYNC® classification corresponds to eye movements that are consistent with a lack of concussion. A positive EYE-SYNC® classification corresponds to eye movements that may be present in patients with concussion.

The SyncThink EYE-SYNC device is a portable, fully enclosed eye tracking environment with three primary components: - 1. Eye Tracker (head-mounted device) with eye tracking sensor - 2. Eye tracking display - 3. Android Tablet The eye tracker is a modified Samsung GearVR provided by SensoMotoric Instruments (SMI). It is mounted to the subject's face and held either by hands placed on the side or using a strap. The eye tracking sensor includes two high-speed infrared cameras (for each eye) connected to a visual display for battery, computation, and display. Camera lighting is provided by 12 high-quality Light-emitting Diodes (LEDs) centered at 850 nanometers. Eye gaze tracking is performed using a proprietary implementation of the pupil- corneal reaction method. The eye tracker display is a nonnetworked mobile device that fits within the eye tracking sensor and connects over USB. The display receives eye tracking sensor information for post-processing, manages sensor calibration, provides binocular visual display to the subject, and interfaces with the Android tablet over Bluetooth. Eye gaze tracking and visual display is combined to provide several assessment paradigms to characterize subject eye tracking performance: - Smooth Pursuit - · Saccades - · Vestibular-Ocular Reflex (VOR) - · VOR Cancellation (VORx) An EYE-SYNC software app on the display device manages these functions. The Android tablet is a standard off-the-shelf 9.7" mobile tablet from Samsung with Verizon 4G cellular connectivity. A second EYE-SYNC software app designed to provides an integrative platform for data collected on the HMD eye tracker: - · Patient, administrator, and records management - · Eye tracker assessment Bluetooth control - · Assessment Vestibular/Ocular-Motor Screening (VOMS) self-report tools - · Eye tracker assessment real-time Bluetooth monitoring - Eye tracker data log Bluetooth transfer - Eye tracker assessment analysis using visual synchronization metrics - · Analysis report generation with visualizations - · Background diagnostics to verify device health - · Cloud connectivity for data synchronization Internal batteries from the eye tracking display and Android tablet provide power for remote use, away from power source. Each device has an EYE-SYNC software app installed to provide the described functionality. EYE-SYNC is provided as a complete system and both apps are managed a single software project with identical version numbers. EYE-SYNC is provided in a standalone carry-case with user manual, strap, cleaning, and charging accessories.

The EYE-SYNC is intended for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects.

SyncThink's EYE-SYNC™ consists of two components. These components are provided as a system with preloaded software. The EYE-SYNC is a fullyintegrated, head-mounted eye-tracking system with two primary system components: 1) the head mounted display, containing the eye-tracking hardware and software system; and, 2) an integrated handheld peripheral used to administer the test and store testing results. The eye tracking unit includes two high-speed infrared cameras connected to a dedicated image analysis computing system. Camera lighting is provided by 12 high quality Light-emitting Diodes (LEDs) centered at 850 nanometers. EYE-SYNC is a less than one minute, non-invasive eye-tracking test that provides a quantitative representation of attention using precise measurements of eye gaze position relative to a target stimulus. Eye gaze tracking is performed using a proprietary implementation of the pupilcorneal reaction method. Display and eye tracking are controlled using the attached Windows-based handheld. Batteries provide power for remote use (away from power source). As a subject tracks a predictable moving target that follows a circular trajectory on a screen within the head mounted system, eye gaze position and time stamp are recorded by the use of cameras in the head mounted system. Multiple eye gaze positions relative to the target stimulus are measured and analyzed for position error variability using installed software, and the results are displayed and stored on the handheld peripheral