Search Results

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 provided text describes the regulatory clearance of the EYE-SYNC device. Here's a breakdown of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: 1,069 subjects
• Data Provenance: The study was a retrospective analysis of subjects ages 17-24 years actively engaged in competitive athletics. The location/country of origin is not explicitly stated, but the context of FDA clearance for a US market implies the data is relevant to a US population or sufficiently representative thereof. The study involved patient evaluations conducted by healthcare practitioners blinded to EYE-SYNC device output "+3 days from injury," suggesting it was collected progressively for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not explicitly stated as a specific number of individual experts.
• Qualifications of Experts: The ground truth for concussion was established using the SCAT-5 clinical reference standard definition of concussion, with evaluations conducted by "a healthcare practitioner blinded to EYE-SYNC device output." While specific qualifications like "radiologist with 10 years of experience" are not provided, "healthcare practitioner" implies a medical professional (e.g., physician, athletic trainer, nurse practitioner) trained in concussion assessment.

4. Adjudication Method for the Test Set

• The text states that the SCAT-5 clinical reference standard definition of concussion was used, with evaluations conducted by a single healthcare practitioner who was blinded to the EYE-SYNC device output. There is no mention of multiple readers or an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" seems to have been based on this single blinded practitioner's assessment using the SCAT-5.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done to evaluate how much human readers improve with AI vs. without AI assistance. The study focuses on the standalone algorithm's performance in aid of diagnosis. The device's use is explicitly "in conjunction with a standard neurological assessment," implying it's an aid to a human clinician, but the study itself does not measure the human-in-the-loop performance change.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone performance evaluation was clearly done. The reported sensitivity, specificity, PPV, and NPV are for the EYE-SYNC device's classification algorithm. The healthcare practitioner who established the ground truth was "blinded to EYE-SYNC device output," which supports this being a standalone performance assessment of the algorithm against clinical ground truth.

7. Type of Ground Truth Used

• The ground truth used was expert consensus / clinical reference standard: The SCAT-5 clinical reference standard definition of concussion, as determined by a blinded healthcare practitioner. This is a widely accepted clinical tool for concussion assessment.

8. Sample Size for the Training Set

• The text does not explicitly state the sample size for the training set. The provided data focuses solely on the "validation data analysis" performed on 1,069 subjects, which represents the test set.

9. How Ground Truth for Training Set Was Established

• Since the training set size is not provided, the method for establishing its ground truth is also not explicitly described in this document. It is typically assumed that training data ground truth would be established through similar expert labeling or clinical diagnosis processes, but no details are given here.

Ask a specific question about this device

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

This document (K152915) is a 510(k) summary for the EYE-SYNC device, a nystagmograph. It states that "No performance data was required or provided." and that "Software validation and verification demonstrate that the EYE-SYNC performs as intended and meets its' specifications."

Therefore, based on the provided document, the following information about acceptance criteria and a study proving device performance cannot be answered:

1. A table of acceptance criteria and the reported device performance: No performance data was provided, thus no acceptance criteria specific to clinical performance are listed, nor are reported performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set was used for performance evaluation as no performance data was required/provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No ground truth for a test set was established as no performance data was required/provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set adjudication occurred as no performance data was required/provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as no clinical performance data or MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no clinical performance data was mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth was established for performance evaluation as no performance data was required/provided.
8. The sample size for the training set: No training set was mentioned as no performance data was required/provided.
9. How the ground truth for the training set was established: Not applicable as no training set was mentioned or ground truth established for it.

The document focuses on demonstrating substantial equivalence to a predicate device (Fall Prevention Technologies, LLC balanceback Mobile Intuitive VNG System K070729) based on identical intended use, similar principles of operation, and similar technological characteristics. The argument is that since the device is substantially equivalent to a legally marketed device, no new clinical performance data was required.

Ask a specific question about this device