(90 days)
The 96 Channel EEG Headbox is intended to be used as an electroencephalograph: to acquire, store, and archive electroencephalographic signals with additional capabilities to record other physiological signals such as pulse oximetry.
The 96 Channel EEG Headbox is a digital electroencephalograph that can also record pulse oximetry signals.
The provided text focuses on the 510(k) summary and FDA clearance letter for a "96 Channel EEG Headbox." It describes the device, its intended use, and substantial equivalence to predicate devices. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in engineering test reports, clinical study summaries, or validation reports, which are not included in the provided text.
Therefore, I cannot provide the requested information based solely on the input given.
To answer your request, I would need a document that describes the design verification and validation testing performed for the 96 Channel EEG Headbox, including:
- Specific performance metrics tested (e.g., signal-to-noise ratio, frequency response, common mode rejection ratio for EEG; perhaps accuracy for pulse oximetry if that was a critical performance characteristic).
- The acceptance criteria for each of these metrics.
- The results of the tests showing that the device met these criteria.
- Details on any clinical studies or usability testing, if performed, including sample size, data provenance, ground truth, and expert involvement.
§ 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).