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

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

The provided text is a 510(k) premarket notification FDA letter for a sterilization process indicator. It is not an AI/ML device and therefore does not contain the information required to answer the prompt.

The document discusses the regulatory approval of the "SteriTec Biological Test Pack with Instant Readout Integrator, Model No.: BI 108" and confirms its substantial equivalence to predicate devices. It outlines the general controls provisions of the Act that apply to the device and provides contact information for further inquiries. The "Indications for Use" section specifies that the device is designed for testing pre-vacuum steam sterilizers at particular temperatures and durations and visually indicates if sterilizing conditions were met.

Since this is a traditional medical device (a biological test pack for sterilization) and not an AI/ML powered device, the concepts of acceptance criteria in the context of AI/ML model performance (e.g., sensitivity, specificity, AUC), sample size for test sets/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable here.

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