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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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