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RSI Rapid Indicator, a multiple, interactive, bacterial enzyme indicator, is used for monitoring saturated steam sterilization processes operating at 121°C gravity, 132°C vacuum assisted 134°C vacuum assisted cycles.

RSI, Rapid Indicator

The provided document is a 510(k) clearance letter from the FDA for the "RSI™ Rapid Indicator for Monitoring Steam Sterilization." This type of document does not contain the detailed study information or acceptance criteria requested.

A 510(k) clearance primarily establishes substantial equivalence to a predicate device already on the market. It confirms that the new device is as safe and effective as a legally marketed device and does not typically delve into the specifics of performance studies in the way you've outlined for AI or diagnostic devices.

Therefore, I cannot provide the requested information from this document. The document confirms the device name, its use for monitoring steam sterilization processes, and its substantial equivalence determination, but no detailed performance metrics, study designs, sample sizes, or ground truth establishment methods are present.

To obtain such information, one would typically need to refer to the original 510(k) submission document itself (which is usually much more extensive than the clearance letter) or published studies related to the device.

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