(101 days)
XLTEK Clear Signal Adhesive Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephalograph (EEG) and Nerve potential signals. The electrodes are for single patient use only.
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I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for "XLTEK Clear Signal Adhesive Electrodes". It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study, including sample sizes, data provenance, number or qualifications of experts, adjudication methods, or ground truth establishment.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Details about training sets.
The document primarily states the device's intended use and confirms its regulatory clearance by the FDA.
§ 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).