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EZTest® - Gas self contained biological indicators are for monitoring the efficacy of ethylene oxide gas sterilization processors. Performance characteristics are established in accordance with USP XXIII for the 600mg/l process.

The biological indicator consists of a self-contained unit which includes: bacterial spores inoculated onto a paper carrier, a small glass ampule containing sterile culture medium and color indicator, and a plastic vial that serves as the culture tube. This unit complies to the performance characteristics described in the USP XXIII.

The acceptance criteria and the study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The EZTest® - Gas biological indicator is designed to meet the performance characteristics described in the USP XXIII. The document outlines several characteristics that were evaluated.

The ultimate reported performance is that the EZTest® - Gas "meets the USP XXIII requirements" for the tested parameters.

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

• Sample Size: The document states that claims were evaluated using "at least three (3) spore lots using different spore crops and different media lots." This indicates that multiple units from these lots would have been tested for each characteristic. However, the exact number of individual biological indicators tested is not specified.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Given that it's a 510(k) submission to the FDA, the studies would likely have been conducted prospectively under controlled laboratory conditions, possibly in the USA, to generate the required performance data.

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

This type of device (biological indicator) does not typically involve human experts establishing a "ground truth" in the way an imaging AI algorithm would. The "ground truth" for a biological indicator is determined by the growth or non-growth of bacterial spores after exposure to a sterilization process and subsequent incubation. This is an objective biological outcome, not a subjective interpretation by human experts.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" is an objective biological outcome (spore growth/no growth), not a subjective assessment requiring adjudication by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation (e.g., radiology AI), not for biological indicators that assess the efficacy of sterilization directly through objective biological endpoints.

6. Standalone Performance Study

Yes, a standalone study (algorithm only without human-in-the-loop performance) was done. For a biological indicator, "standalone performance" refers to the device's ability to accurately reflect the presence or absence of viable spores after a sterilization cycle. The listed evaluations (D-values, survival/kill times, incubation readout, etc.) directly assess the device's inherent performance characteristics in a controlled laboratory setting, independent of human interpretation to determine the primary outcome. The reading of the color change is a direct function of the device's biological and chemical components, not a human reader's diagnostic skill.

7. Type of Ground Truth Used

The ground truth used is based on biological outcomes (growth or non-growth of Bacillus subtilis spores) and established industry standards as defined by the USP XXIII (United States Pharmacopoeia). This involves direct observation of microbial growth (manifested by a color change in the medium) after defined exposure to ethylene oxide and subsequent incubation.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. For a biological indicator, the development and manufacturing process doesn't typically involve machine learning training data. Instead, the "training" (or rather, development and validation) of such a device relies on extensive laboratory testing and adherence to established microbiological and sterilization science principles.

The description implies that the manufacturing process involves "a manufacturing in-process quality control system to specifications defining exacting parameters for production to assure a consistent product and good manufacturing procedures." This ongoing quality control and specification adherence serve a similar purpose to ensuring a consistent "learned" behavior in an AI model, but through traditional engineering and scientific validation.

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

Not applicable in the AI/ML sense. For this device, the "ground truth" for establishing its design and specifications (analogous to a training set for AI) would have been established through:

• Established microbiological principles: Understanding the resistance of Bacillus subtilis spores to ethylene oxide.
• USP XXIII guidelines: Adherence to defined performance characteristics for biological indicators.
• Historical data and scientific literature: Leveraging decades of knowledge related to sterilization processes and biological indicator design.
• Internal R&D and testing: SGM Biotech's own experimentation to develop their specific media formulation, spore carrier, and device configuration to meet the USP XXIII standards.

The "ground truth" for manufacturing quality assurance is established by testing each lot against the USP XXIII specifications for spore count, resistance, and purity.

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