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Electrical Stimulation

The Flexible Rubber Electrodes are a family of electrodes that are supplied as accessories to Enraf-Nonius B.V. nerve and muscle stimulation equipment. Depending on electrode size and connection terminals, the following parts apply: 1460265 6 x 8 cm electrode with 4 mm female connection terminal, 1460272 4 x 6 cm electrode with 4 mm female connection terminal, 1460274 8 x 12 cm electrode with 4 mm female connection terminal, 3444128 4 x 6 cm electrode with 2 mm female connection terminal, 3444129 6 x 8 cm electrode with 2 mm female connection terminal, 3444130 8 x 12 cm electrode with 2 mm female connection terminal. The electrodes consist of carbon filled silicon rubber. For proper electrical contact with the patient the electrodes should be used in combination with moistened sponge pads. The electrode/sponge assembly is wrapped to the patient using fixation straps. Instructions for use are available in the Operating Instructions of the Enraf-Nonius B.V. nerve and muscle stimulators that the electrodes are to be used with. The following accessories apply: 1460266 Sponges Pads 6 x 8 cm, set of 4 pc, 1460273 Sponges Pads 4 x 6 cm, set 4 pc, 1460275 Sponges Pads 8 x 12 cm, set 4 pc, 3444020 Fixation strap 100 x 3 cm, 3444021 Fixation strap 250 x 3 cm.

The provided text is a 510(k) Summary for Flexible Rubber Electrodes. It describes the device, its indications for use, and a comparison of its technological characteristics to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or study designs (like sample sizes, expert involvement, or adjudication methods) that would typically be associated with proving a device meets acceptance criteria in the context of an AI/ML medical device.

The document is a submission for regulatory clearance (510(k)) for a physical medical device (electrodes), not an AI/ML product. The "Substantial Equivalence Summary" part focuses on comparing the new electrodes to existing ones based on physical characteristics (current density, power density), adherence to standards (IEC, MDD, CFR), and biocompatibility (cytotoxicity, skin irritation, dermal sensitization). These are traditional engineering and safety evaluations, not performance metrics derived from AI/ML models.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device or its associated study, as that content is not present in the provided document.

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