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SteriTec Green Tape can be used in 121°C gravity sterilizers for 30 minutes or pre-vacuum sterilizers operating at 132°C for 4 minutes and 135°C for 3 minutes. Stripes turn black after exposure to steam sterlization conditions, thus providing identification of processed items.

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The provided document {0-2} describes the FDA 510(k) clearance for the SteriTec Green Tape, Model No: CI 159/1, CI 159/.5, CI 159/.75. This document focuses on the regulatory approval process and includes an "Indications for Use" section.

However, the document does not contain the detailed information necessary to answer the specific questions about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a diagnostic AI/medical imaging device.

The SteriTec Green Tape is a sterilization process indicator, which is a chemical indicator designed to demonstrate that an item has been exposed to a sterilization process. It's not a diagnostic device involving complex algorithms, image analysis, or human reader interpretation in the way your questions are framed (e.g., radiologists, AI assistance).

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document for the type of device you envision. The information you are requesting is typically found in pre-market submission summaries for more complex diagnostic devices, not for a chemical sterilization indicator.

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