(182 days)
The electrotherapy electrodes are intended to be used to apply electrical stimulation current to the patient's skin or record physiological signals
This type of electrode features a high density carbon mesh that evenly distributes current throughout the electrode surface. It connects to a TENS device through single or twin lead wire. Various standard sizes can be chosen. Any custom design can also be manufactured.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for "Self-Adhesive Electrodes" and primarily focuses on establishing substantial equivalence to predicate devices, regulatory information, and intended use.
The text explicitly states that no clinical investigation was performed: "Therefore, we need not perform clinical investigation. And, the safety and performance of Adhesive Electrodes is verified." This means there would be no study to describe in the context of device performance against specific acceptance criteria.
The document refers to "Testing reports, analysis" and "Performance Characteristics (If/when applicable) — 1. See the Exhibits." However, the actual content of these reports or exhibits, which would contain detailed performance data and acceptance criteria, is not included in the provided text.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using the provided input.
§ 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).