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SteriTec Biological Test Pack with Instant Readout Integrator is a single-use device designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The provided text describes a 510(k) premarket notification for a medical device called the "SteriTec Biological Test Pack with Instant Readout Integrator, Model No.: B1 111." This device is a biological indicator designed for testing pre-vacuum steam sterilizers.

However, the document is a regulatory clearance letter, not a scientific study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, the detailed information requested regarding acceptance criteria, device performance, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (MRMC) is not available within this document. This letter does not provide the results of any clinical or performance studies.

To answer your questions comprehensively, information from the actual device validation study would be needed, which is not included in this FDA 510(k) clearance letter.

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