(258 days)
The Eye Monitor is used to observe eye movements from various stimuli used in vestibular diagnostic testing. It allows observation of horizontal, vertical and torsional eye movements.
The Eye Monitor is mainly used to visually detect nystagmus positional maneuvers (e.g. Hallpike positional tests) or caloric tests. The device is especially useful in situations where the operator needs to observe the patient 's eyes to distinguish nystagmus from artifacts. These observations are currently done using Fresnel lenses.
The eye movements could also be recorded on suitable media (e.g. video tape) to provide documentation for any diagnosis based on observation of the Eye Monitor.
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The provided text is a 510(k) clearance letter from the FDA for a device called "Video Eye Monitor" (also referred to as "VISUALEYES: VIDEO EYE MONITOR"). This document does not contain information about acceptance criteria, device performance, a study to prove meeting acceptance criteria, sample sizes, expert qualifications, or types of ground truth.
The letter states that the device is "substantially equivalent" to predicate devices marketed before May 28, 1976, which means it has met the regulatory requirements for clearance based on this equivalence. It describes the intended use of the device: "to observe eye movements from various stimuli used in vestibular diagnostic testing. It allows observation of horizontal, vertical and torsional eye movements. The Eye Monitor is mainly used to visually detect nystagmus positional maneuvers... or caloric tests. The device is especially useful in situations where the operator needs to observe the patient's eyes to distinguish nystagmus from artifacts."
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or similar technical documentation that would detail the device's performance against specific acceptance criteria.
§ 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).