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The Steri-Dent / Steri-Sure Self-Seal Nylon Pouch is intended to be used to allow sterilization of enclosed medical instruments by a dry heat sterilizer operating at 160°C (320°F) for 1 hour (60 minutes) and also to maintain the sterility of the enclosed instruments for 30 days after sterilization.

The Steri-Dent Self-Seal Nylon Pouches are single use sterilization wraps that provide a means for health care providers to enclose metal instruments, which are sterilized in a dry heat sterilizer, and to maintain sterility of the instruments until they are used. The pouches can be used in dry heat sterilizers with a sterilization cycle of 1 hour (60 minutes) operating at 160°C (320°F) such as the Steri-Dent Model 2100 and 3100. The nylon pouches will maintain the sterility of the instruments for a maximum of 30 days. If the instruments inside the pouch are not used within 30 days after being sterilized, they should be removed, placed in a new bag and resterilized.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets such criteria in the context of AI/ML performance. The document describes a medical device (Steri-Dent Self-Seal Nylon Pouch) and its non-clinical performance data related to sterilization, but it does not involve AI or ML.

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