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The ECG lead wire is intended only for the purpose of connecting an ECG monitoring electrode to either an ECG monitor trunk cable or directly into a monitor or transmitter and conducting the patients ECG signal.

This device is a patient lead wire. These patient lead wires are manufactured from a variety of electronic conductors, electronic insulating materials, patient end termination and patient lead wire connectors. This variety of materials and assembly configurations is needed to allow for designs that would be disposable, reusable, x-ray translucent or non x-ray translucent. These materials are all typically and commonly used by other companies participating in the market.

The provided text describes a 510(k) submission for 3M Red Dot™ ECG Lead Wires and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document focuses on the device description, regulatory classification, and predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

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