(188 days)
The Lifecare electrodes are intended to be used with transcutaneous neurostimulation devices. Some common types of neurostimulation devices include, but are not limited to, TENS devices and powered muscle stimulation devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patinet's skin and a neurostimulation device.
Lifecare: 5 x 5 CM Square, 4 x 4 CM Square, 5 CM Round, 7.5 CM Round, 4 x 6 CM Oval, 5 x 10 CM Oval, 4 x 8 CM Rectangle, 5 x 10 CM Rectangle. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patinet's skin and a neurostimulation device.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Lifecare Neurostimulation Electrode," indicating that the device has been found substantially equivalent to predicate devices. It lists the device name, regulation number, regulation name, product code, and the indications for use.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details as this 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).