(82 days)
The EveTrak™ is used to non-invasively measure the vertical and horizontal eve movements during a variety of tests performed during electronystagmography (ENG) testing. This testing includes, but is not limited to: saccadic test, smooth pursuit, optokinetic nystagmus, and kinetic vestibular tests. It provides a trained clinician with data and graphs representing a patient's ability to perform certain eve movements voluntarily, as well as the patient's involuntary eye movements due to head movement, eye movement and/or body movement as is normally performed in vestibular diagnostic testing such as in Hallpike positional tests. It is used, then, to aide in the detection and diagnosis of vestibular disorders. The results are used to provide documentation of a patient's performance on specific tests.
The EyeTrak™ instead measures horizontal and vertical eye movement non-invasively using infra-red sensors and an IR oculography method with background light suppression. This allows for direct transmission of sensor signals to a processing unit, which in turn provides the signals to the software for processing, saving, and presentation. A camera and monitor can be used to monitor torsional eye movements, and a sensor can be added to measure head movement.
The provided document is a 510(k) clearance letter for the EyeTrak™: ENG System, and an Indications for Use statement for the device. It does not contain information about acceptance criteria for device performance, nor does it describe any study proving the device meets specific performance criteria.
Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study demonstrating device performance. This type of information is typically found in a device's design control documentation, test reports, or clinical study summaries, which are not part of this 510(k) clearance letter.
§ 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).