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Tenax White Posts are for use where ever endodontic posts are required and where esthetic considerations and/or where known allergies to metals are of concern.

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This is a 510(k) submission letter, not a study or device performance report. Therefore, the requested information regarding acceptance criteria, study details, and performance metrics for a medical device is not available in the provided text.

The document states that the FDA has reviewed the Section 510(k) notification for the "Tenax White Post" and determined it to be substantially equivalent to devices marketed prior to May 28, 1976. This means the device is cleared for market based on its similarity to existing legal devices, rather than through a new clinical trial demonstrating performance against specific acceptance criteria.

The "Indications for Use" section (page 2) describes the intended purpose of the Tenax White Posts ("for use where ever endodontic posts are required and where esthetic considerations and/or where known allergies to metals are of concern"), but it does not provide any performance data or acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided document.

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