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The Twister Oxygen Concentrator is intended to provide oxygen to persons requiring low flow oxygen therapy. This device is not intended to be life supporting nor life sustaining.

The Twister produces concentrated oxygen from room air for delivery to a patient requiring low flow oxygen therapy. The oxygen from the air is concentrated using a molecular sieve and a pressure swing adsorption process.

"This document, a 510(k) premarket notification letter from the FDA, approves the marketing of the ""Twister Oxygen Concentrator."" However, it does not contain any information regarding specific acceptance criteria, device performance metrics, or study details. The letter primarily addresses the regulatory classification and substantial equivalence of the device to previously marketed devices.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, or study design based on the provided text."

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