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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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