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surface electrode for electroencephalography
The Electrode Store
Summary: The surface electrode for electroencephalography (EEG) by The Electrode Store is used for recording electrical activity in the brain. Key evidence highlights its role in measuring high-frequency oscillations, a potential biomarker in epilepsy.
FDA Clearance Information
Pathway
510K
Number
K022197 ↗
Decision Date
August 13, 2002
Product Code
GXY
Device Class
Class 2
Evidence
0 studies
The surface electrode for EEG was cleared by the FDA via the 510(k) pathway on August 13, 2002. It is manufactured by The Electrode Store and classified as a Class 2 device.
What It Is
The surface electrode for EEG is a device used to record electrical activity from the brain's surface. It is primarily used in clinical settings to diagnose and monitor neurological conditions such as epilepsy.
Clinical Applications
Commonly used in hospitals and clinics, this device aids in diagnosing epilepsy, sleep disorders, and other neurological conditions by capturing brain wave patterns. It is essential in pre-surgical evaluations for epilepsy patients.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, prospective, and retrospective studies, published between 2021 and 2024. These studies explore various aspects of electrode design and its impact on EEG measurements.
Reported Outcomes
Published studies report that electrode surface area significantly impacts the measurement of high-frequency oscillations in EEG, which are crucial for assessing surgical outcomes in epilepsy. The design and placement of electrodes also affect signal quality and diagnostic accuracy.
Safety Profile
Reported complications include potential skin irritation at the electrode site and signal interference due to improper electrode placement. No severe adverse events have been documented in the reviewed studies.
Evidence Limitations
Evidence gaps include a lack of large-scale studies directly comparing different electrode designs. Further research is needed to standardize electrode placement and improve signal accuracy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for surface electrode for EEG?
The device is indicated for recording brain activity to diagnose and monitor neurological conditions such as epilepsy and sleep disorders.
What outcomes have been reported in clinical studies?
Studies report that electrode design affects the measurement of high-frequency oscillations, which are important for evaluating epilepsy treatment outcomes.
What complications have been reported?
Safety data indicate minor complications such as skin irritation and signal interference, with no severe adverse events reported.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.