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This document is a 510(k) premarket notification letter from the FDA regarding "Alpha-Pro White Varnish." It is not a study or regulatory document that contains the detailed information requested.

Therefore, I cannot provide the acceptance criteria and study details you've asked for based on the provided text. The document confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not include performance data, detailed study designs, or acceptance criteria.

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed submission document that describes the studies conducted for this device.

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