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ISurg Disposable Subdermal Needle Electrodes are intended for use with monitoring, recording and electrical stimulation equipment specifically designed for the recording of biopotential signals from electroencephalography (EEG), electromyography (EMG) and nerve potential studies. ISurg Disposable Subdermal Needle Electrodes are "Rx Only", intended for "Single Use Only" and "Sterile".

1Surg Disposable Subdermal Needle Electrodes are the conduit between the monitoring equipment and a patient. The electrode has a small gauge stainless steel needle on one end (which is subdermally positioned by a licensed physician or technologist under his (which is subcoman) pointener on the other (a safety connector which is connected to the monitoring equipment) with a small gauge wire connecting the two. The safety connector is an industry standard DIN 42802 protected connector and cannot be connected to an AC outlet.

1Surg Disposable Subdermal Needle Electrodes are used in the study of biopotentials such 13ang Disposable Daoublik (FG), electromyography (EMG), nerve conduction and evoked as crootials. They are "Rx Only", disposable (for "Single Use Only"), sterile and invasive as they are placed subcutaneously in or near nerve and muscle tissue.

I am sorry, but the provided text does not contain any information regarding acceptance criteria, device performance tables, study details like sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The document is a 510(k) summary for ISurg Disposable Subdermal Needle Electrodes, primarily focusing on its substantial equivalence to predicate devices. It describes the device, its intended use, and technological characteristics, but it does not include data from a study to prove acceptance criteria are met.

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