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Terragene® Bionova® BT20 Biological Indicator is a Self-Contained Biological Indicator (SCBI) intended for routine monitoring of the efficacy of the following steam sterilization processes:

• Gravity-displacement Steam Sterilization Cycles

121 °C, 30 minutes
132 °C, 25 minutes
132 °C, 15 minutes
132 °C, 10 minutes
134/135 °C, 10 minutes

• Vacuum-assisted Steam Sterilization Cycles

121 °C, 20 minutes
132 °C, 4 minutes
134/135 °C, 3 minutes

Terragene® Bionova® BT20 provides a final result after a 24 hour incubation at 60 ± 2 °C.

Device Description

Terragene® Bionova® BT20 Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a filter paper spore carrier inoculated with a minimum of 10⁶ viable Geobacillus stearothermophilus ATCC® 7953 spores and a glass ampoule containing purple culture medium, enclosed with a plastic colored cap and a barrier permeable to steam. The culture medium contains a pH indicator that changes color upon acidification by the metabolism of living spores. On each BT20 Biological Indicator there is a propylene label printed with a chemical process indicator that changes from pink to brown when exposed to steam.

Final results: 24-hour readout after incubation at 60 °C. If the sterilization process was successful, culture medium will remain purple. If sterilization was not successful, culture medium will turn to yellow during incubation, thus indicating the presence of live G. stearothermophilus spores.

AI/ML Overview

This document describes the acceptance criteria and the study proving the Terragene® Bionova® BT20 Biological Indicator meets these criteria.

It's important to note that this device is a Biological Indicator for sterilization, not an Artificial Intelligence (AI) or medical imaging device. Therefore, some of the requested information (like multi-reader multi-case studies, ground truth establishment for AI training, etc.) is not applicable. The information provided focuses on the rigorous testing required for biological indicators to demonstrate their efficacy in monitoring sterilization processes.

1. A table of acceptance criteria and the reported device performance

The following table summarizes the acceptance criteria and the "Results" कॉलम में "Passed" यह बताता है कि डिवाइस ने उन सभी मापदंडों को सफलतापूर्वक पूरा किया है।

Test Performed	Purpose	Acceptance Criteria	Reported Device Performance
Viable Spore Population Assay	Demonstrate that the product meets specifications for spore population.	- 50 to 300% of manufacturer's nominal population (ISO 11138-1:2017).- ≥ 10⁵ CFU/BI unit (FDA Guidance, ISO 11138-3:2017).	Passed
Resistance Characteristics Study	Evaluate the resistance characteristics (D-value, Z-value, Survival Time, Kill Time).	- D-value₁₂₁°C: ≥ 1.5 minutes- D-value₁₃₂°C: ≥ 10 seconds- D-value₁₃₅°C: ≥ 8 seconds- Z-value: ≥ 10°C- Minimum Expected Survival Time₁₂₁°C: ≥ 5 minutes- Minimum Expected Survival Time₁₃₂°C: ≥ 1 minute- Minimum Expected Survival Time₁₃₄/₁₃₅°C: ≥ 40 seconds- No negative results at Minimum Expected Survival Time.- No positive results at Maximum Expected Kill Time.	Passed
Recovery Protocols: Recovery Medium Test	Test suitability of the culture medium.	- All inoculated samples show positive result (color change to yellow) after 7-day incubation at 60°C.- Negative controls (uninoculated) show negative result (medium remains purple) after 7-day incubation at 60°C.	Passed
Carrier and Primary Packaging Materials Evaluation	Evaluate effect of materials on spore viability and suitability.	- No "no growth" in exposed carrier samples.- No "no growth" in unexposed carrier samples.<br;- No "no growth" in exposed primary packaging samples.- No "no growth" in unexposed primary packaging samples.- Valid growth medium controls.	Passed
Reduced Incubation Time (RIT) Test	Validate the 24-hour Reduced Incubation Time.	24-hour RIT sensitivity ≥ 97% for each partial sterilization cycle for all three batches.	Passed
Holding Time Assessment	Validate maximum 7-day holding time between exposure and incubation.	- D-value within ± 20% following holding time.- All inoculated samples positive after 7 days incubation at 60°C.- Negative controls negative under same conditions.	Passed
Shelf Life Study (Biological Indicator)	Demonstrate stability of specifications throughout labeled shelf life.	- Spore population: 50% to 300% of initial nominal value.- D-Value: within ± 20% of initial value.- Product performance: Negative result for successful sterilization (purple), Positive result for unsuccessful/control (yellow) after 24-hour incubation at 60°C.	Passed
Performance Study for Bionova® BT20 Biological Indicator	Verify performance in claimed cycles.	The Biological Indicator should perform as intended in claimed cycles.	Passed
Pass/Fail Criteria for Chemical Indicator Label	Validate performance of chemical process indicator.	- Pass conditions: CI turns brown.- Fail conditions: CI does not reach endpoint.- Dry heat: No color change or significantly different from endpoint.	Passed
Endpoint Stability for Chemical Indicator Label	Demonstrate stability of endpoint reaction for CI.	Stability of endpoint reaction demonstrated at end of shelf life and for at least 6 months.	Passed
Shelf Life Study for Chemical Indicator Label	Provide real-time data for CI endpoint response.	Stability of endpoint reaction demonstrated throughout shelf life when stored under labeled conditions.	Passed
Biocompatibility for Chemical Indicator Label	Demonstrate CI label does not offset or transfer.	CI should not release any substance or bleed when in contact with substrate and subject to sterilization.	Passed

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific numerical sample sizes for each test in terms of "number of devices tested." However, it consistently refers to testing "three batches analyzed" for critical tests like Viable Spore Population Assay and Reduced Incubation Time (RIT) Test. This suggests a minimum sample size of three batches of the biological indicators for key performance evaluations.

Data Provenance: The studies were non-clinical performance tests conducted by the manufacturer, Terragene S.A., based in Alvear, Santa Fe, Argentina. The studies are by nature prospective, as they involve manufacturing the device and then subjecting it to controlled tests to demonstrate performance against established standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the device is a biological indicator for sterilization monitoring, not an AI or medical imaging device that relies on expert human interpretation for ground truth. The "ground truth" for a biological indicator is defined by the objective outcome of sterilization cycles (e.g., whether spores are killed or grow) and the established scientific standards for spore population, resistance, and growth media. These are measured objectively in a laboratory setting.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI evaluations where human experts are making subjective assessments that need to be reconciled. For a biological indicator, the results are objective (e.g., color change, spore growth/no growth, D-value calculation) based on laboratory protocols defined by ISO standards and FDA guidance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This is a biological indicator designed to monitor sterilization, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this device.

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

This information is not applicable. The device is a physical biological indicator, not an algorithm. Its performance is evaluated in a standalone manner as a biological entity in controlled sterilization and incubation environments, without human intervention during the "reading" phase (i.e., the color change is observed visually or automatically after incubation, it's not a human performing a complex interpretation). The "algorithm" in this context is the biological response of the spores.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for a biological indicator is primarily established through:

Microbiological Viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions, confirmed by observed growth or no growth in a suitable culture medium.
Physical Parameters: Precisely controlled and measured physical parameters of the sterilization cycles (temperature, time, pressure) that are known to either kill or allow survival of the specific spore population.
Referenced Standards: The "ground truth" is also defined by the detailed specifications and methodologies outlined in international standards such as ISO 11138-1:2017, ISO 11138-3:2017, and ISO 11138-8:2021, and FDA Guidance documents for biological indicators. These standards define the acceptable D-values, spore populations, survival times, and kill times under specified conditions.

Essentially, the ground truth is based on established scientific and microbiological principles and standardized test methodologies rather than subjective expert consensus or pathology.

8. The sample size for the training set

This information is not applicable as the device is a biological indicator and does not involve AI or machine learning that requires a "training set" of data.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above.

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