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Like the predicate devices, the North State Plastics Aerosol Tee is intended for use in providing a conduit for aerosol medications and respiratory gases.

The device is injection molded from clear, rigid, clean, chemically inert K-Resin KRO3-NW. The Aerosol Tee is equipped with standard 18 and 22 mm OD fittings for connection to most aerosol devices.

I am sorry, but the provided text describes a 510(k) summary for a medical device called the "North State Plastics Aerosol Tee". This document is for a simple, non-AI medical device and does not contain any information about acceptance criteria, device performance metrics, clinical studies with human readers, or AI algorithms.

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

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