(276 days)
The Wrap Accessory Electrodes are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as back, neck, shoulder, elbow, wrist, knee and foot.
The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as back, neck, shoulder, elbow, wrist, knee and foot.
The provided text is a 510(k) clearance letter from the FDA for a medical device called "Wrap Accessory Electrodes." It primarily addresses the regulatory approval process and includes a description of the device's intended use.
However, the document does NOT contain any information about acceptance criteria, device performance data (e.g., accuracy, sensitivity, specificity), sample sizes for testing or training, expert qualifications for ground truth establishment, adjudication methods, or MRMC studies.
Therefore, I cannot answer your request using the provided text. The information required to describe the acceptance criteria and the study that proves the device meets them is not present in this document.
§ 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).