(83 days)
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The AQUABOND electrode is a disposable EEG cutaneous electrode that uses an aqueous, conductive adhesive to bond an Ag/AgCl disk to the skin. Because the adhesive is aqueous, removal is quick and unaccompanied by odors from organic solvents, as is the case with electrodes attached with pastes, such as Collodion. The AQUABOND electrode comprises a silver/silver chloride (Ag/AgCI) coated plastic base with an attached aqueous conductive adhesive component. The electrode is supplied in a dry state and when the conductive, adhesive component is wet with common tap water, it becomes sticky and can be attached to the skin, even in locations with hair, to provide a well adhering, low impedance electrode.
The provided text is a summary of safety and effectiveness for a medical device called AQUABOND, submitted in 1996. It describes the device, its predicate devices, and asserts substantial equivalence. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth, or any of the other specific details requested in your prompt.
This document is a regulatory submission for a simple electrode, not a complex AI-powered diagnostic device. Therefore, the types of studies and performance metrics you are asking about (e.g., MRMC studies, standalone algorithm performance, AI assistance effect size) would not be applicable or present in this kind of submission for such a device.
To address your request, I would need a different type of input document – one that describes the validation or clinical study of a device, preferably one that involves AI or complex diagnostic capabilities.
§ 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).