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The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent montoring of the following STERRAD Sterlization Systems and has been validated for use in health care facilities:

• . STERRAD 100S
• o STERRAD 50
• . STERRAD 200
• o STERRAD NX®
• . STERRAD 100NX® (Standard, Flex and Express Cycles)
  • For STERRAD 100NX DUO Cycle in the United States, the STERRAD CYCLESURE 24 Biological 0 Indicator should only be used in a test pack configuration (REF 20243).

The STERRAD CYCLESURE 24 Biological Indicator (BI) is a self-contained stand- alone biological monitor intended for the routine monitoring of the STERRAD Sterilization Process. It consists of a glass fiber disc containing a minimum of 1x106 Geobacillus stearothermophilus spores, a glass ampoule containing nutrient growth medium, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion.

The document describes a 510(k) premarket notification for the STERRAD® CYCLESURE® 24 Biological Indicator. The primary modification being sought is an extension of the labeled shelf life from 6 months to 9 months. The information provided focuses on demonstrating that this shelf life extension does not impact the device's performance or safety.

Here's a breakdown of the requested information based on the provided text:

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

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

The document does not explicitly state the specific sample sizes for the stability studies. It mentions "Stability studies were conducted" in the plural, implying multiple tests were performed.
The data provenance is not specified in terms of country of origin, but it is explicitly prospective as the studies were conducted to verify the device's stability over an extended shelf life.

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

This question is not applicable to this submission. The device is a biological indicator designed to monitor sterilization processes, and its performance is evaluated against predefined biological and chemical metrics (spore population, D-value, color change), not against expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

This question is not applicable, as the evaluation is based on objective scientific measurements and laboratory testing, not human interpretation requiring adjudication.

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 question is not applicable. The device is a biological indicator, not an AI-powered diagnostic tool for human readers.

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

This question is not applicable. The device is a physical biological indicator, not a software algorithm. Its performance is inherent to its design and biological components, and it functions standalone in the sense that it indicates sterilization failure or success without human intervention beyond observing the color change or culture results.

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

The ground truth for this device's performance is established by well-defined scientific and microbiological specifications. These include:

• Minimum viable spore population: 1 x 10⁶ Geobacillus stearothermophilus spores/BI (as per the device description).
• Resistance characteristics: D-value at 2.5 mg/L of hydrogen peroxide (≥ ~1 second), calculated survival time, and a kill time of 60 seconds.
• Positive BI color test: The indicator should demonstrate the expected color change (from red to golden yellow or bronze) when exposed to hydrogen peroxide.

These are objective, quantitative measures for a biological indicator.

8. The sample size for the training set

This question is not applicable. The device is not an AI/ML model that requires a "training set." Its performance is based on its inherent physical and biological properties.

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

This question is not applicable, as there is no training set for this type of device.

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The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:

• STERRAD® 100S
• STERRAD® 50
• STERRAD® 200
• STERRAD® NX®
• STERRAD® 100NX® (Standard, Flex and Express Cycles)
• For STERRAD® 100NX® DUO Cycle in the United States, the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).

The STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained standalone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 1x10^6 Geobacillus stearothermophilus spores, a glass ampoule containing nutrient growth medium, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion.

The provided text describes a 510(k) summary for a biological indicator, the STERRAD® CYCLESURE® 24 Biological Indicator. This device is a self-contained biological monitor used to verify the effectiveness of STERRAD® sterilization processes.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Passed" for all studies, implying that the device met the pre-defined acceptance criteria for each test. The specific quantitative acceptance criteria are not explicitly detailed in this summary for each test, but are inherent in the "Passed" designation for regulatory submissions of this type.

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. The testing methodology for biological indicators typically involves a statistically significant number of replicates, but the exact numbers are not provided in this summary.

Regarding data provenance: The tests were conducted to confirm the performance of the STERRAD® CYCLESURE® 24 Biological Indicator when used with STERRAD® Sterilization Systems. This indicates that the data was generated specifically for the device in question, likely in a controlled laboratory or testing environment. The country of origin of the data is implicitly the country where Advanced Sterilization Products (Irvine, CA, USA) conducted its research and development, but this is not explicitly stated. The studies are prospective in nature, as they are designed to evaluate the performance of a new or modified device.

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

For a biological indicator, the "ground truth" is established through standardized microbiological and sterilization efficacy testing methods. This does not involve human expert consensus in the same way an image interpretation study would. Instead, the ground truth is determined by:

• Microbiological assays: Confirming the presence and viability of spores.
• Sterilization efficacy: Determining if the sterilization process effectively inactivates the spores under controlled conditions.
• Colorimetric changes: Observing the chemical or biological indicator's color change as designed.

Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth in this context is not directly applicable as it would be for, for example, a diagnostic imaging device. The "experts" would be qualified microbiologists and engineers overseeing the test procedures, rather than a panel of clinicians.

4. Adjudication Method for the Test Set

Adjudication methods like "2+1" or "3+1" are typically used for studies involving subjective human interpretation, such as medical image reading where discrepancies between readers need to be resolved. This is not applicable to the nonclinical performance testing of a biological indicator, where results are generally objective (e.g., growth/no growth, specific color change, quantitative measurements). The "adjudication" is inherent in the validation protocols and quality control measures of the testing procedures.

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

No. An MRMC comparative effectiveness study is not applicable here. This type of study assesses how human performance (e.g., diagnostic accuracy of radiologists) changes with or without the assistance of an AI-powered device. The STERRAD® CYCLESURE® 24 Biological Indicator is a standalone device for monitoring sterilization, not a diagnostic aid for human interpretation.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Yes, a standalone performance study was done. The nonclinical tests listed (Evaporation, Verification of Positive BI Color, Bacteriostasis, BI Validation, Verification of Minimum Incubation Time, Growth Promotion, Spore Resistance Testing) all represent the performance of the biological indicator itself, without human intervention in its function. The device is a "self-contained standalone biological monitor."

7. Type of Ground Truth Used

The ground truth used for evaluating the biological indicator is based on:

• Microbiological viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to varying levels of sterilant, typically confirmed through incubation and observation of growth.
• Chemical indicator response: The expected color change of the chemical indicator on the cap, confirming exposure to hydrogen peroxide.
• Growth media efficacy: The ability of the nutrient growth medium to support microbial growth.
• Standardized sterilization cycles: The defined parameters of the STERRAD® Sterilization Systems represent the "truth" of the sterilization conditions.

Essentially, the ground truth is established by objective microbiological and physical measurements under controlled conditions.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or artificial intelligence algorithms. This device is a biological indicator that functions based on microbiological principles, not a machine learning algorithm. Therefore, there is no "training set" in the AI sense. The development of such a device involves extensive R&D and validation, but not statistical machine learning training on a dataset.

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

As there is no "training set" in the context of an AI/ML algorithm for this biological indicator, this question is not applicable. The development of the device's performance characteristics is based on established sterilization science, microbiology, and materials science principles, and its effectiveness is validated through the nonclinical studies listed in the summary.

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The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles.

STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained stand-alone biological monitor intended for the routine monitoring of the STERRAD® Sterilization Process. It consists of a glass fiber disc containing a minimum of 108 CFU of Geobacillus stearothermophilus spores, a glass ampoule containing nutrient growth medium, a cap and liner closing the vial and a chemical indicator on top of the cap. The cap contains two small circular openings that allow for diffusion of hydrogen peroxide vapor into the vial. The relatively small size of the circular openings serves as a restriction to this diffusion.

The provided 510(k) summary describes a biological indicator, not an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) do not apply to this submission.

However, I can still extract the acceptance criteria and performance data for the biological indicator and address the relevant points from your request.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a table format with corresponding numerical performance metrics for each criterion in the manner typically seen for AI/ML device performance. Instead, it lists validation studies that were conducted and reports a "Passed" status for each. This indicates that the device met the internal specifications or established thresholds for each validation study.

Study Details (as applicable to a biological indicator)

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

The document does not specify the exact sample sizes (number of BIs) used for each validation study. The data provenance is internal to Advanced Sterilization Products, Division of Ethicon, Inc., and the studies appear to be prospective validation tests conducted by the manufacturer to demonstrate the device's performance. No country of origin for "data" in the context of clinical populations is relevant here as it's a lab-based performance validation study.

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

Not applicable. This is not an AI/ML device where expert interpretation determines ground truth for a test set. The "ground truth" for a biological indicator is based on microbiological growth or non-growth under controlled conditions, which are objective measurements.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation or diagnosis in AI studies. For a biological indicator, the outcome (growth or no growth, color change) is a direct, observable, and quantifiable result of a controlled microbiological experiment.

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

Not applicable. This is not an AI/ML device, so no MRMC study involving human readers and AI assistance was conducted.

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

Not applicable. This is a standalone biological indicator, not an algorithm. Its "standalone performance" is its ability to accurately indicate the presence or absence of sterilizing conditions based on microbial viability. The validation studies listed (e.g., Evaporation, Growth Promotion, Spore Resistance) represent its standalone performance characteristics.

7. The type of ground truth used

The ground truth used for these validation studies is microbiological growth/viability or physical/chemical property verification. For instance:

• For "Verification of Positive BI Color" and "Growth Promotion," the ground truth is the actual presence and growth of viable Geobacillus stearothermophilus spores.
• For "Spore Resistance" and "BI Validation in STERRAD Sterilizers," the ground truth is the known exposure to sterilant and the expected survival/kill rate of the spores.
• For "Evaporation" and "Bacteriostasis," the ground truth relates to the integrity and functional properties of the device under test conditions.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, and therefore, there is no "training set" in the context of machine learning.

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

Not applicable, as there is no training set for an AI/ML model.

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