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SteriTec Green Card Pack Bowie-Dick Test is a single designed to detect the presence of residusl air in pro-veauum steam sterilizers operating at 132°C for 3.5 minutes. The indicator card within the Green Card Pack will demonstrate a uniform color change from purple to green when proper sterlization conditions are met and no air is present to create a 2° C (+19-0° C) temperature difference between the center of the towel pack, as identified in ANSVAAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the indicator card within the Green Card Pack will demonstrate a non-uniform color change.

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This document is a marketing authorization letter for a medical device (SteriTec Green Card Pack Bowie-Dick Test) and does not contain the detailed study information required to answer the prompt. The request asks for acceptance criteria and study details, including sample sizes, data provenance, expert qualifications for ground truth, adjudication methods, MRMC study results, standalone performance, and how ground truth for training data was established. This marketing authorization letter, specifically pages 1-3, focuses on regulatory approval, substantial equivalence, and indications for use. It does not provide the technical details of a performance study demonstrating acceptance criteria.

Therefore, I cannot fulfill the request using only the provided text.

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SteriTec Green Card Pack Bowie-Dick Test is designed to detect the presence of residual air in pre-vacuum steam sterilizers operating at 132°C for 3.5 minutes. The indicator card within the Green Card Pack will demonstrate a uniform color change from purple to green when proper sterilization conditions are met and no air is present. If enough air is present to create a 2° C (+1°-0° C) temperature difference between the center of the towel pack, as identified in ANSI/AAMI/ISO 11140-5, and the drain temperature at the beginning of the final one minute of a three and half minute cycle the indicator card within the Green Card Pack will demonstrate a non-uniform color change.

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The provided document is a 510(k) clearance letter for the SteriTec Green Card Pack Bowie-Dick Test, Model BD 126. It describes the device's intended use and FDA's determination of substantial equivalence. However, this document does not contain the detailed acceptance criteria for a study or the results of such a study.

The letter mentions that the device is "substantially equivalent" to legally marketed predicate devices, which implies that the device likely underwent testing to demonstrate this equivalence. However, the specific design of that testing, including the acceptance criteria, sample sizes, ground truth establishment, or any comparative effectiveness studies, is not included in this regulatory clearance letter.

Therefore, I cannot provide the requested information from the given text. To answer your questions, one would need access to the actual 510(k) submission data, which would include the performance testing report.

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