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PG47xW SERIES cutaneous disposable electrodes with cable connection are intended for use with neurostimulation equipment designed for transmission of electric impulses to patient's skin.

PG47xW SERIES are disposable adhesive electrodes with solid conductive gel. They consist of a conductive pad made of three primary layers: a non-woven fabric top, a carbon filled film and a solid hydrogel adhesive layer. Between the conductive film and the insulating top a 10 cm long cable is attached, terminated with 2 mm touch proof socket for the connection with electro-stimulating devices. Multiple shapes and sizes are available to accommodate placement on various location on the body. The electrodes are passive devices serving as interface between transcutaneous neurostimulation devices and the patient's skin. The electrodes are non-sterile and for single patient use only.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for cutaneous electrodes (FIAB PG47xW SERIES). Its purpose is to demonstrate substantial equivalence to a predicate device (Valuetrode, K970426), not to present performance study data against
pre-defined acceptance criteria.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria: The document explicitly states: "Although there are no guidance performance standards, as reported in Section 18, the electrodes are produced and tested according to all requirements laid down by the regulations in force so as to guarantee safety and effectiveness." This indicates that there are no specific, quantitative acceptance criteria defined and presented in this summary for the device's performance.
• No Performance Study: The document claims equivalence based on "technological characteristics equivalent to those of the predicate devices" and that "The performance is expected to be the same as predicate device. See section 12 of the submission." Section 12 is referenced, but its content is not
  provided in this summary. This suggests that a direct performance study to meet specific acceptance criteria was either not conducted or not detailed in this publicly available summary. Instead, it relies on the presumed safety and effectiveness of the legally marketed predicate device.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth establishment, expert involvement, or multi-reader studies. The document does not provide such details.

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