Search Results

The Electrode Store™ Subdermal Needle Electrode for Electroencephalography (EEG) is intended for single-use, subdermal application to record physiological signals or to apply electrical stimulation. It is indicated for use with adult or pediatric patients as a recording or stimulating electrode during electroencephalography.

Subdermal Needle Electrode for Electroencephalograpy

I am sorry, but the provided text from the U.S. Food and Drug Administration (FDA) correspondence and the "Indications for Use Statement" for the "Subdermal Needle Electrode for Electroencephalography" does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness with AI.

The documents are solely related to the 510(k) premarket notification process, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on detailed performance studies or AI integration.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

Ask a specific question about this device