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The ConMed Linvatec Zen™ Wireless Footswitch and Adapter is an accessory that is intended to interface with compatible ConMed Linvatec power drive consoles to selectively control ConMed Linvatec surgical instruments.

The ConMed Linvatec Zen™ Wireless Footswitch and Adapter consists of a Wireless Footswitch (W1000) and a Wireless Footswitch Adapter (W1100) used for control of handpieces connected to a compatible ConMed Linvatec drive console. The Wireless Footswitch is designed to receive a communication signal from the Wireless Footswitch Adapter and, when a footswitch pedal is depressed, activate the drive console accordingly to power a ConMed Linvatec handpiece.

The provided text is a 510(k) summary for the ConMed Linvatec Zen™ Wireless Footswitch and Adapter. This document focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria or a study proving device performance against such criteria.

The 510(k) document is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It typically includes comparisons to predicate devices in terms of intended use, technological characteristics, and performance data (which often includes design verification and validation testing, but not necessarily a clinical study with detailed acceptance criteria as you've described).

Therefore, I cannot extract the requested information as it is not present in the provided text.

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