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The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle ("Cycle 1"). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1. The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized hydrogen peroxide (H2O2 or VHP) and ozone (O3) which are both used in the STERIZONE® VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to have equivalent to greater resistance than worst case devices and loads in any load configuration.

The STERIZONE® BI+ Self-contained Biological Indicator (TSO3 product code 42602) consists of at least 106 Geobacillus stearothermophilus viable spores, known to be the reference microorganism for the STERIZONE® VP4 Sterilizer sterilization process, grouped on a stainless steel carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. The presence of G. stearothermophilus spores is detected by a visual color change (media turns yellow). The yellow color change indicates bacterial growth. No change of color indicates that the process achieved the conditions necessary to kill at least 1 × 106 viable spores of G. stearothermophilus (6 logs) on the SCBI inoculated stainless steel carrier. The final readout of a negative result (media remains purple) is made after 18 hours of incubation when using a dry-bath type incubator.

The STERIZONE® VP4 Test Pack is a device composed of the STERIZONE® BI+ Selfcontained Biological Indicator (TSO3 product code 42602, including crusher), a 10 mL syringe and its plunger, and a diffusion restrictor (sold in the form of a kit - TSO3 product code: 44020). A STERIZONE® CI+ Chemical Indicator (TSO3 product code 43810) is also added, external to the syringe, to allow differentiating processed test packs. All components of the Test Pack are single-use, disposable items.

The provided document describes the STERIZONE® BI+ Self-contained Biological Indicator and STERIZONE® VP4 Test Pack and includes a summary of nonclinical performance tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each of the nonclinical tests. It only lists the tests performed and their results. The data provenance is not specified (e.g., country of origin, retrospective/prospective). These were likely laboratory-based studies conducted by the manufacturer, TSO3 Inc., in Québec, Canada.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests performed are objective, laboratory-based assays (e.g., population counts, growth inhibition) that do not typically rely on human expert consensus for ground truth establishment in the way clinical diagnostic devices might.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided in the document. The tests are scientific measurements or observations with clear pass/fail criteria, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The STERIZONE® BI+ Biological Indicator is a sterilization process indicator evaluated through laboratory performance tests.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself is a physical biological indicator, not a software algorithm. Therefore, the concept of "standalone (algorithm only)" is not applicable. The performance evaluation is based on the biological and chemical responses of the indicator to sterilization conditions.

7. The Type of Ground Truth Used

The ground truth for these nonclinical tests is based on established scientific principles and standards for biological indicators and sterilization efficacy.

• Viable population assay: Ground truth is the measured number of viable spores, compared against a specified range (e.g., $\ge1 \times 10^6$ viable spores).
• Growth inhibition: Ground truth is the observation of microbial growth/no growth in the presence/absence of carrier materials and pack materials.
• Reduced incubation time/stability of biological read/positive controls: Ground truth is the presence or absence of spore growth within specified timeframes or under specific conditions.
• BI validation in the STERIZONE® VP4 process & Test Pack performance evaluation: Ground truth is the kill of a specified log reduction of Geobacillus stearothermophilus spores (6 logs) under defined sterilization conditions (half-cycle vs. full cycle).

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. The tests described are validation tests for the physical device's performance characteristics. Development and optimization of the biological indicator would have involved internal testing, but this is not detailed as a "training set."

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" in the AI/ML sense, this question is not applicable. The device's performance is established through direct physical and biological testing against known sterilization challenges, rather than through a learning algorithm trained on data.

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