(183 days)
The EEG-1200A Series Neurofax is intended to record, measure and display cerebral and extracerebral activity for EEG and Sleep Studies. These data may be used by the clinician in Sleep Disorder, Epilepsies and other related disorders as an aid in diagnosis. The device is intended for use by medical personnel in any location within a medical facility, laboratory, clinic or nursing home or outside of a medical facility under direct supervision of a medical professional.
The EEG-1200A Electroencephalograph is the instrument to provide the information for intervention to utilize derivation, recording, analysis, or each combination of the brain's action potential. The instrument can measure the vital signal (including ECG waveform, EMG waveform, respiration waveform, ocular motility, SpO2 and CO2) in relation to EEG examination and display the waveform on the screen changing the montage and amplifier conditions. In addition, measurement data is available to file into the electric media. Changing the montage and amplifier conditions, then record to the printer, previews the measured data filed into the electric media. EEG data analysis is also executed to use the analysis software.
The provided text describes the Nihon Kohden EEG-1200A Series Neurofax, an electroencephalograph (EEG) device. It includes a 510(k) summary, intended use, and a comparison to a predicate device. However, it does not contain information about specific acceptance criteria, a detailed study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI devices.
The "study" mentioned in the document refers to engineering verification and validation testing, not clinical performance studies with human subjects or AI-specific evaluations.
Therefore, I will extract relevant information from the provided text to construct the table and address the questions as much as possible, indicating when information is "Not provided" by the source.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specified in 510(k) context as "Technological Characteristics" comparable to predicate) | Reported Device Performance (New Device: EEG-1200A Series Neurofax) |
|---|---|
| Number of channels | 32 |
| Noise Level (0.53 to 60 Hz) |
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).