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The Raven ProPACT Peracetic Acid Culture Test Kit is intended for use with STERIS SYSTEM 1™, a liquid chemical sterilization system. The ProPACT Peracetic Acid Culture Test Kit provides independent confirmation that sterilization conditions were achieved during the STERIS SYSTEM 1 processing cycle. A reduced incubation time of 48 hours has been validated for the Raven ProPACT Peracetic Acid Culture Test Kit.

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Because the provided text is a regulatory 510(k) clearance letter from the FDA, it outlines the regulatory approval for a medical device but does not contain the detailed scientific study information requested. The letter confirms substantial equivalence to a predicate device and provides general information about regulatory compliance. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or the number/qualifications of experts.
3. Adjudication methods.
4. Information on MRMC studies or effect sizes.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request with the provided input. This document serves as a regulatory approval notice, not a scientific study report.

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