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"A device used to remove particles from the air for medical purposes"

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The provided text is a 510(k) premarket notification letter from the FDA regarding an "Advanced Air Cleaner System." It indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

However, the letter does not contain any information about acceptance criteria or specific studies proving the device meets them. The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials or detailed performance studies that would typically include acceptance criteria and reported device performance.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval letter, not a technical report detailing performance metrics or study designs.

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