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The KSEA Quadro Switch, in conjunction with its associated handpiece, functions as a suction/irrigation control switch device to control the rinsing and removal of carbon deposits, blood clots, or excised tissue from operative sites during surgical procedures.

The Quadro Switch is a microprocessor controlled device connected at the interface between a suction/irrigation handpiece and a legally marketed irrigation/suction pump via two separate pieces of silicone irrigation and suction tubing.

The provided text is a 510(k) summary for the KSEA Quadro Switch, a device intended to control suction/irrigation during surgical procedures. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as requested.

The text focuses on confirming substantial equivalence to predicate devices, providing administrative details, and describing the device's intended use and function. It explicitly states: "The minor differences between the KSEA Quadro Switch and the predicate devices raise no new questions of safety or effectiveness." This implies that no new performance studies were required or performed to demonstrate safety and effectiveness beyond establishing equivalence to existing technologies.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies from this document.

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