(316 days)
Measuring temporal characteristics of saccadic refixation responses when viewing lateral visual stimulus and identifying the individual time delays of moving the eyes toward the stimuli.
The Saccadometer system measures eye movements in horizontal axis with temporal 1kHz and spatial resolution
The provided FDA 510(k) summary for the Saccadometer Plus and Saccadometer Advanced devices describes performance data, but does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner typical for clinical trials or formal validation studies. Instead, it presents results of various tests demonstrating the device's characteristics and performance.
Therefore, the table below will list the reported device performance characteristics based on the provided text, rather than explicitly stated acceptance criteria. For questions where the information is not provided in the document, it will be stated as "Not provided."
Acceptance Criteria and Reported Device Performance
| Characteristic / Acceptance Criteria Type | Reported Device Performance |
|---|---|
| Saccade Detection Algorithm Accuracy | Mean absolute error of saccadic latency measurement is below 2 ms. The influence of parameters of pseudosaccade course (amplitude, rising edge, trigger to slope delay-simulated latency) changes on the latency of measurement error is also below the value 1ms. |
| Measurement Linearity | Mean averaged maximal linearity error for range ±15 degrees was observed. Linearity error increased with the increase of measurement ranges, but it is noted that human fixation has an error of ±0.3 degrees. The device is primarily used for ±10 degree measurement range. |
| Spatial Resolution | All gathered results were within the declared measurement resolution (5 arcmin or better). The device's eye movement sensor has a spatial resolution |
§ 886.1510 Eye movement monitor.
(a)
Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.(b)
Classification. Class II.