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

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° 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.

This document describes the validation of the STERRAD® CYCLESURE® 24 Biological Indicator. However, it does not involve an AI device, therefore many of the requested categories are not applicable.

Here's the information extracted from the provided text, with clarification regarding the inapplicability of AI-specific questions:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states "Performance testing demonstrated that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended in a newly developed STERRAD® 100NX™ Express Cycle." Specific quantitative acceptance criteria are not detailed in the provided text. The performance data is presented qualitatively as "Passed" for each study.

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

• Sample Size: The document does not specify the exact sample size for each test.
• Data Provenance: The testing was conducted by Advanced Sterilization Products, a division of Ethicon, Inc. The data is from nonclinical laboratory tests rather than human patient data, therefore country of origin and retrospective/prospective distinctions are not applicable in the typical sense for medical imaging or AI.

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. The device is a biological indicator for sterilization. Its "ground truth" is determined by microbiological and chemical validation methods, not by expert interpretation of images or clinical data.

4. Adjudication method for the test set:

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of data, typically in studies involving human interpretation or clinical outcomes. This device's performance is assessed through laboratory testing.

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. This is not an AI device, and an MRMC study is not relevant to its validation.

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

This question is not applicable. This is not an AI algorithm. The device, a biological indicator, operates independently of human interpretation for its primary function (indicating sterilization efficacy), though humans read the results. The "standalone" concept for an AI algorithm doesn't apply here.

7. The type of ground truth used:

The ground truth for a biological indicator is established through:

• Microbiological assays: Verification of spore kill (or survival) based on established protocols for sterilization efficacy testing (e.g., D-value, Z-value determinations for sterilization resistance).
• Chemical indicator changes: Visual color changes indicating exposure to sterilant.
• Growth medium changes: Observation of growth/no-growth in sterile culture, indicating spore survival or kill.

The document refers to "BI validation in STERRAD® 100NX™ Express Cycle (Dose Response)" which implies methods to determine logarithmic reduction of spores, a standard ground truth for biological indicator performance.

8. The sample size for the training set:

This question is not applicable. This is not an AI device, and therefore does not have a "training set" in the context of machine learning.

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

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

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

The STERRAD® CycleSure® 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 1x10 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.

This document describes a 510(k) premarket notification for a modified biological indicator, the STERRAD® CycleSure® Biological Indicator. The primary modification is a change in the culture media formulation to achieve a reduced incubation time of 24 hours. Given that this is a biological indicator for sterilization processes and not an AI/ML powered device, several of the requested categories (e.g., number of experts, adjudication method, MRMC study, sample size for training set) are not applicable or cannot be extracted from the provided text.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each individual test (e.g., color reversion, bacteriostasis, fill volume, incubation time, growth support, stability). It broadly refers to "test data" and "studies" conducted.

• Provenance: The studies were conducted by Advanced Sterilization Products, Inc. (ASP) to confirm the performance and quality characteristics of the modified culture media. The specific country of origin for the data is not mentioned, but ASP is based in Irvine, CA, USA, suggesting the studies were likely conducted in the US. The studies appear to be prospective as they were conducted to test the performance of the modified device.

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

This is not applicable for this type of device. The "ground truth" for a biological indicator is determined by objective microbiological and chemical tests (e.g., presence/absence of microbial growth, color change, pH measurements), not by human expert opinion or interpretation in the way it would be for an image-based diagnostic AI.

4. Adjudication method for the test set

This is not applicable. As described above, the ground truth is established through objective laboratory testing, not human expert 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 is not applicable. This device is a biological indicator, not an AI-powered diagnostic tool, and therefore, an MRMC study involving human readers and AI assistance is irrelevant.

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

This is not applicable. This is a physical biological indicator, not an algorithm. Its "performance" is its ability to accurately indicate sterilization.

7. The type of ground truth used

The ground truth for this device's performance is based on objective laboratory measurements and microbiological assays. This includes:

• Observing microbial growth (Geobacillus stearothermophilus).
• Monitoring color changes (yellow for positive, stable for non-reversion).
• Measuring pH.
• Assessing fill volume.
• Stability testing over time.

8. The sample size for the training set

This is not applicable. This is not an AI/ML device that requires a training set. The term "training set" refers to data used to train a machine learning model.

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

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

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The STERRAD® CycleSure™ Biological Indicator is intended for use by healthcare providers for monitoring of the sterilization process in STERRAD® Sterilization Systems. STERRAD® CycleSure™ Biological indicator is designed to accompany medical devices placed in the sterilizer.

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

The STERRAD® CycleSure™ 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 100 Bacillus stearothermophilus spores placed inside a plastic vial, a glass ampule containing nutrient growth medium also inside the vial, 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.

After exposure to the sterilization process, the cap is pressed down until firmly seated against the top of the vial in order to close the vial is then placed into the supplied tube crusher and squeezed until the media ampule is crushed. The entire device is then placed into an incubator and incubated in an upright position at 55° C to 60° C. After incubation, the medium in the vial is observed for a change in color from purple (indicating no growth) to yellow (indicating growth).

The STERRAD® CycleSure™ Chemical Indicator (on the cap) serves as a chemical process indicator (throughput indicator) [Class A per EN867-1] for the STERRAD® Sterilizer cycle. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.

The provided text describes a 510(k) premarket notification for a modified STERRAD® CycleSure™ Biological Indicator. However, the document focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria, sample sizes, and ground truth establishment.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, ground truth methodologies, and expert qualifications are not explicitly available in the provided text.

Based on the information available:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size for Test Set: 18 different lots of CycleSure BIs were tested. The exact number of BIs within each lot tested is not specified.
• Data Provenance: Not specified, but given it's a product from Advanced Sterilization Products, a Johnson & Johnson company based in Irvine, CA, the testing was likely conducted in the US or under their global quality system. The study is retrospective in the sense that it's a post-modification release test rather than a prospective clinical trial.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The determination of "consistent and appropriate" methods would likely involve internal testing and validation professionals.

4. Adjudication method for the test set:

• Not specified. The document refers to "methods used to test the product for final release," implying standard laboratory testing protocols.

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 device is a biological indicator for sterilization monitoring, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a physical device that relies on a biological response to determine sterilization effectiveness, not an algorithm. The "reading" is a visual color change observed by a human after incubation.

7. The type of ground truth used:

• The ground truth for a biological indicator is typically established by comparing its response (growth/no growth) to known conditions of sterility (or lack thereof) in a controlled sterilization process, often verified by other established methods (e.g., physical/chemical indicators, or direct sterility testing of products). The document mentions "new methods" based upon a "BIER vessel," which is a Biological Indicator Evaluator Resistometer – a standard device for evaluating BI performance under controlled conditions. This suggests a controlled laboratory environment where the sterility challenge is precisely known and verified.

8. The sample size for the training set:

• Not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

• Not applicable.

Summary of Device Modification and Study:

The core of this 510(k) submission is a modification to the methods used to test the product for final release. The device itself (the STERRAD® CycleSure™ Biological Indicator) remains largely the same as its predicate (same indicated use, operating principle, design, materials, shelf life, and packaging). The "study" described is a nonclinical test of 18 different lots of the modified BI, using these new release testing methods. The conclusion of this testing was that the new methods were deemed "consistent and appropriate for the evaluation and release of CycleSure BIs," implying that the device continued to meet its performance requirements when evaluated by the updated testing procedures.

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

The STERRAD® CycleSure™ 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 106 Bacillus stearothermophilus spores placed inside a plastic vial, a glass ampule containing nutrient growth medium also inside the vial, 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.

After exposure to the sterilization process, the cap is pressed down until firmly seated against the top of the vial in order to seal the vial is then placed into the supplied tube crusher and squeezed until the media ampule is crushed. The entire device is then placed into an incubator and incubated in an upright position at 55° C to 60° C. After incubation, the medium in the vial is observed for a change in color from purple (indicating no growth) to yellow (indicating growth).

The STERRAD® CycleSure™ Chemical Indicator (on the cap) serves as a chemical process indicator (throughput indicator) [Class A per EN867-1] for the STERRAD® Sterilizer cycle. Exposure of the chemical indicator to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.

The provided text describes the STERRAD® CycleSure™ Biological Indicator and its validation. It does not contain information about an AI/ML powered device. Therefore, I will extract the information for the biological indicator.

Acceptance Criteria and Device Performance for STERRAD® CycleSure™ Biological Indicator

This document describes the validation of the STERRAD® CycleSure™ Biological Indicator (BI), a self-contained biological monitor for routine monitoring of STERRAD® Sterilization Processes. The studies primarily focused on the chemical indicator, spore population, D-value, incubation time, bacteriostasis, and growth media performance and stability.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Chemical Indicator Validation: The specific number of samples for each condition (simulated heavy load, no load, plasma presence, H2O2 absence) is not explicitly stated, but it was "evaluated by observing the color."
• Incubation Time Determination: Three different lots of BIs, each consisting of one hundred samples, were tested.
• Bacteriostasis (STERRAD® 100 & STERRAD® 50): For each sterilizer, twenty STERRAD® CycleSure™ Biological Indicator samples prepared with uninoculated glass fiber discs (10 test, 10 negative controls) and ten additional samples prepared without glass fiber discs (positive controls) were used.
• Growth Media Validation: Media lots were prepared, and testing was conducted, but specific sample sizes for each test are not provided.
• Performance Validation: Not explicitly stated, but performed "using three different spore crops."
• Shelf-Life (Stability) Validation: Three different manufacturing lots of BIs were used, with portions of each lot placed into different storage conditions. Samples were periodically removed and tested.

Data Provenance: The studies were conducted by Advanced Sterilization Products, a division of Ethicon, Inc., based in Irvine, California. Implied to be prospective in nature as the studies were conducted to validate a new device prior to commercialization. The origin is the USA.

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

Not applicable. The ground truth for this biological indicator is based on quantifiable biological and chemical responses (e.g., spore inactivation, color change, growth promotion) rather than subjective expert assessment. The testing standards (ISO 11138-1, CDRH Guidance Document) dictate the methodology.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements and observations (e.g., color change, microbial growth/no growth, D-value calculation) that do not require an adjudication process by multiple reviewers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This product is a biological indicator, not an AI/ML powered device that would involve human readers for interpretation.

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

While the device operates "standalone" in the sense that it functions without continuous human intervention during sterilization and incubation, this is not an AI/ML algorithm. Its "performance" refers to its physical and biological function as described.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Biological Activity: The viability and inactivation of Bacillus stearothermophilus spores.
• Chemical Reactions: The color change of the chemical indicator in response to hydrogen peroxide.
• Standardized Methods: Adherence to established industry standards like ISO 11138-1 and CDRH Guidance Documents for biological indicator evaluation.
• Laboratory Testing: Direct measurement of pH, growth promotion, bacteriostasis, and stability in controlled laboratory environments.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML powered device, so there is no "training set" in the context of machine learning. The studies described are validation and performance tests of a physical product.

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

Not applicable. As this is not an AI/ML device, the concept of a "training set" and establishing ground truth for it does not apply.

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