(182 days)
DermaBioSafe Neuro-muscular Electrodes are intended for use as the disposable, conductive adhesive interface between a patient's skin and the Electrical Stimulator. DermaBioSafe Neuro-muscular Electrodes are intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), and EMS (Electrical Muscular Stimulation).
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This document is a 510(k) clearance letter from the FDA for a medical device called "DermaBioSafe Neuro-muscular Electrodes". It primarily concerns the regulatory approval of the device and its indications for use.
Based on the provided text, there is no information about:
- Acceptance criteria or reported device performance
- Details of any study (sample sizes, data provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone studies, or training set information)
The letter states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance typically relies on demonstrating equivalence to existing devices rather than requiring new clinical performance studies with acceptance criteria and detailed study designs as might be found for novel technologies or higher-risk devices.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them from this document. The document's purpose is to grant regulatory clearance, not to detail device performance studies.
§ 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).