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The 3M Red Dot™ 2560 & 2570 Monitoring Electrodes are intended for use in ECG Monitoring. The 2560 and 2570 electrodes can be used in all ECG applications where standard ECG monitoring electrodes are used. These electrodes can be used for short term and long term (up to 5 Days) monitoring.

The 3M Red Dot™ 2560 & 2570 ECG Monitoring Electrodes are a selfadhesive, non-sterile, single use disposable electrode which includes a silver/silver chloride sensing element and conductive sticky gel. These electrodes include a pressure sensitive adhesive foam tape which hold the conductive elements of the electrode in place on the patient's skin for short or long term ECG procedures.

This document describes the safety and efficacy of the 3M Red Dot™ 2560 and 2570 Monitoring Electrodes. However, it does not provide the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, or ground truth for a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Biocompatibility Testing: Stating that materials were selected based on ISO 10993-1.
• Performance Testing: Stating that electrical performance meets ANSI/AAMI EC12/1991 for Disposable ECG Electrodes.

Therefore, I cannot populate the requested tables and information based on the provided text. The prompt asks for details related to a study proving the device meets acceptance criteria, which is not present in this 510(k) summary excerpt beyond a general statement of compliance with a standard.

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