(39 days)
The Electrode Store™ Surface Electrodes for Electroencephalography are intended for non-invasive use as recording electrodes in studies of physiological signals. These devices are indicated for use with adult or pediatric patients during electroencephalography, including biofeedback, sleep studies and evoked potential recordings.
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This document is an FDA 510(k) clearance letter for a medical device: "Surface Electrode for Electroencephalography." It confirms that the device is substantially equivalent to a predicate device already on the market.
Based on the provided text, there is no information about acceptance criteria or the study that proves the device meets specific performance criteria.
The document is purely a regulatory clearance. It does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts used for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The FDA 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a detailed study proving performance against specific acceptance criteria in the same way a novel high-risk device might. The "evidence" typically provided in a 510(k) submission to show substantial equivalence usually includes:
- Comparison of technological characteristics.
- Comparison of indications for use.
- Performance data (e.g., bench testing, electrical safety, biocompatibility) to show that any differences in technological characteristics do not raise new questions of safety or effectiveness.
However, the specific content of such studies is not included in this clearance letter. The letter simply states that the FDA "reviewed your Section 510(k) premarket notification" and "determined the device is substantially equivalent."
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).