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Nev's Ink Autoclave Tapes are used to hold sterilization packs together and as a process indicator in steam sterilizers. When exposed to gravity steam sterilizers operating at 121℃ for 10 minutes and pre-vacuum steam sterilizers operating at 134℃ for 2 minutes, the word "Autoclaved" turns pink. This provides identification of processed items.

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This document is a 510(k) premarket notification letter from the FDA to Nev's Ink, Incorporated regarding their "Nev's Ink Autoclave Tapes." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance, study designs (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance), or training set details.

The letter primarily addresses the FDA's decision on substantial equivalence based on the indications for use statement, product regulation, and general controls provisions of the Federal Food, Drug, and Cosmetic Act. The "Indications for Use Statement" on page 7 describes how the device works (turns pink when autoclaved) but doesn't provide performance metrics or studies to prove that it meets specific criteria.

Therefore, I cannot answer your request based on the provided input.

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