(153 days)
Electroencephalograph (EEG) needle electrodes are needles intended to be inserted into the subdermal tissue of the scalp to sense the minute electrical signals (waveforms) of the brain. This device is an accessory to the electroencephalograph machine, which is for use in connection with neurological studies. EEG electrodes are indicated for use by or on the order of a licensed physician and intended for single patient use, only.
Disposable EEG Needle Electrode
This document is an FDA 510(k) clearance letter for a medical device: a Disposable EEG Needle Electrode. It primarily focuses on the regulatory determination of substantial equivalence to a predicate device.
Therefore, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a new device.
The letter states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This means the manufacturer demonstrated that their device is as safe and effective as a device already on the market, usually by comparing its technological characteristics and intended use.
In summary, none of the requested information regarding acceptance criteria and device performance studies can be extracted from this document because it is a regulatory clearance letter, not a clinical study report or technical specification document.
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).