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RSI Process Challenge Device is intended to be used in conjunction with RSI Rapid Indicators for Monitoring Steam Sterilization to monitor the effectiveness of wrapped loads at 132°C/134°C vacuum assisted steam sterilization cycles.

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I am sorry, but the provided text from the FDA 510(k) letter dated April 23, 1999, for the "RSI® Process Challenge Device for Monitoring Steam Sterilization Process" does not contain the detailed information required to answer your request about acceptance criteria and a study proving device performance.

The letter primarily:

• Acknowledges receipt and review of the 510(k) submission.
• States that the device is substantially equivalent to pre-amendment devices.
• Informs the manufacturer that they can market the device, subject to general controls and good manufacturing practices.
• Provides contact information for further inquiries.
• Includes an "Indications for Use Statement" for the device.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Details on experts used for ground truth or adjudication methods.
4. Information about MRMC or standalone studies.
5. The type of ground truth used.
6. Sample size for a training set or how its ground truth was established.

To obtain this information, one would typically need to refer to the full 510(k) submission document itself, which would contain the detailed testing protocols and results that the FDA reviewed to make its substantial equivalence determination. The letter provided is simply the FDA's decision communication.

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