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The Propper BI-O.K. steam biological indicator is indicated for use in testing both gravity displacement steam sterilizers at 121°C and prevacuum steam sterilizers at 134°C.

The Propper BI-O.K. self contained steam biological indicator consists of a plastic vial and cap which contain a paper strip impregnated with a known number of B. stearothermophilus spores and a sterile sealed glass ampule containing a modified Soybean Casein Digest Medium with pH indicator. Following exposure in a steam sterilizer, the glass ampule is crushed by squeezing the sides of the plastic vial , thus bringing the medium into contact with the spores. The vial is incubated at 56± 2℃ for at least 24 hours. If any of the spores survived the sterilization process, they will grow and produce acid. This will cause a drop in pH of the medium and change the indicator from red to yellow.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document is a 510(k) submission summary for a biological indicator and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to previously marketed devices. However, it does not include a detailed study with specific performance metrics against acceptance criteria.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, sample sizes, ground truth establishment, or details about MRMC or standalone studies.

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