(86 days)
The 2D VOG -- Video-Oculography system provides information to assist in the diagnosis of vestibular disorders by measuring, recording, storing, displaying, and analyzing nystagmus of the eye.
The 2D VOG measures horizontal and vertical eye movements and analyzes the eye movements for nystagmus beats and velocity. The results are visually displayed in different diagrams and are stored in a patient manager together with patient data. The device is intended to provide information for use by the health care professional, in conjunction with other clinically relevant information, in the diagnosis of vestibular disorders.
The 2D VOG consists of a video camera mounted in a mask to record eye movements, an image processing board to digitize and analyze eye movement data, a video-overlay board and PC for real time display of eye movements, and software to analyze and display eye movement data. The system has a patient database for storage of patient data and results.
The 2D VOG system software is used for nystagmus analysis during spontaneous nystagmus, caloric. smooth pursuit, optokinetic, rotation, positional, and saccadic examinations.
The provided text describes a 510(k) submission for the SensoMotoric Instruments 2D VOG - Video-Oculography device, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria.
The document is a summary of the device, its intended use, and the FDA's determination of substantial equivalence to a predicate device. It primarily focuses on the regulatory aspects for market clearance rather than detailed performance study results.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, or clinical study designs, as this information is not present in the provided text.
The closest information available related to performance is the statement: "Both devices use similar technology, including PC and computer monitor, masks mounted with video cameras, and software for performing spontaneous, caloric, positional, rotational, optokinctic, saccadic, and smooth pursuit examinations. The devices utilize the same sampling rate and illumination wavelength." This indicates that the device's technical specifications and intended use mirror those of the predicate device, but no performance metrics are given.
§ 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).