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SteriTec Integraph-E is a steam sterilization integrator for use in a pre-vacuum steam sterilization process at 132°C (270° F) for 2 minutes or 4 minutes. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.

SteriTec Integraph-E is a steam sterilization integrator. When exposed to steam sterilization conditions Integraph-E strips give an integrated response and visible indication that sterilization were met by changing from a purple to green color.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a sterilization indicator, SteriTec Integraph-E. It indicates that the device has been found substantially equivalent to a predicate device for its stated indications for use.

Crucially, it does not include any details about a study with acceptance criteria, device performance, sample sizes, ground truth establishment, or expert reviews. These types of details are typically found in the 510(k) submission summary or in the actual study reports, which are not part of this clearance letter.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the detailed questions about a study based on the provided text.

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