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Metallic Fabric Electrodes are cutaneous electrodes to be used with legally marketed TENS or NMES devices. The Metallic Fabric Electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include wrist, elbow or arm, knee or leg and back band.

Metallic Fabric Electrodes (Model A:Leg Band with Electrodes, Model B:Back Belt with Electrodes, Model C:Arm Band with Electrodes, Model D:Knee and lower lee band with Electrodes, Model F:Triple Action Back Belt with Electrodes, Model G:Leg Rest with Electrodes - I, Model H:Leg Rest with Electrodes - II, Model I:Shirt with Electrodes) are cutaneous electrodes.

I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding "Metallic Fabric Electrodes." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment.

The document primarily focuses on:

• The FDA's review and determination of substantial equivalence for the device.
• Regulatory information and requirements for the manufacturer.
• The indications for use for the Metallic Fabric Electrodes.

Therefore, I cannot fulfill your request based on the provided input.

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