(191 days)
Guardian 150 electrode is intended for use with TENS and NMES, including for Muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction.
Guardian 150 electrode is a single-patient, single use, self-adhering electrode for use with TENS and NMES, and available in cloth (models 150. 151. 152 and 3637), pre-wired (model 3637), snap (models 150, 151 and 152) and pin style (model 3637) configurations. It is latexfree.
The provided text does NOT describe acceptance criteria for a medical device or a study that proves the device meets specific acceptance criteria.
Instead, the documents are:
- A 510(k) summary for the "Guardian 150 electrode" from SelectiveMed™ Components, Inc.
- An FDA letter confirming the substantial equivalence of the Guardian 150 electrode to predicate devices.
- The "Indications for Use" for the Guardian 150 electrode.
These documents establish the device's classification, intended use, and substantial equivalence to existing devices. However, they do not contain any information regarding specific performance acceptance criteria or a study that outlines how these criteria were met.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, ground truth, expert qualifications, or comparative effectiveness studies, as that information is not present in the provided text.
§ 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).