(119 days)
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no clinical performance data was mentioned.
- 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.
- The sample size for the training set: No training set was mentioned as no performance data was required/provided.
- 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.
§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).