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The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles. It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.

The STERRAD® BI Test Pack (BI Test Pack) consists of a plastic tray with a clear top which contains a STERRAD® Biological Indicator paper strip containing 10° Bacillus subtilis var. niger spores, a STERRAD® BI Test Pack Indicator Strip and a length of latex tubing. The BI spore strip is packaged in a Tyvek/Mylar peel pouch to protect the spore strip during handling.

The narrow opening and channels leading to the BI Test Pack and the absorptive properties of the latex tubing provide a diffusion restrictive environment which contributes to the effective resistance of the indicator organism. Included with the BI Test Pack are individual BI spore strips in Tyvek/Mylar peel pouches to serve as positive controls in the microbiological testing.

The STERRAD® BI Test Pack Chemical Indicator Strip included in the Test Pack serves as a chemical process indicator (Class A per EN867-1) for the STERRAD® Sterilizer cycle. Exposure of the chemical indicator strip to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.

Here's a breakdown of the acceptance criteria and study information for the STERRAD® BI Test Pack, based on the provided text:

Acceptance Criteria and Device Performance

The provided text focuses on the modification of an existing device (STERRAD® BI Test Pack) to include performance characteristics for new sterilizer models (STERRAD® 50 and STERRAD® 100S). The core acceptance criteria revolve around the "Survival and Kill characteristics" of the biological indicator within these new sterilization processes. While explicit numeric acceptance criteria are not detailed in the provided text, the overall performance goal is to demonstrate that the STERRAD® BI Test Pack accurately reflects the sterilization process in these new models, as it did in the original STERRAD 100 Sterilizer.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: The text states that "three different manufacturing lots of STERRAD BI Test Packs" were used. The exact number of individual BI Test Packs or sterilization cycles tested per lot is not specified.
   • Data Provenance: The study appears to be prospective, as it was conducted specifically to generate "new performance data" for the STERRAD 50 and STERRAD 100S sterilizers. No country of origin for the data is explicitly mentioned, but the applicant (Advanced Sterilization Products) is located in Irvine, California, USA, implying the studies were likely conducted in the US or under US regulatory standards.

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

   • This is a study of a biological and chemical indicator, not an algorithm or diagnostic device that requires human interpretation of complex images or data. The "ground truth" for a biological indicator is typically established by microbiological methods (e.g., culturing the spore strips to determine viability after a sterilization cycle) and chemical reaction observation (color change). Therefore, the concept of "experts" to establish ground truth in the typical clinical sense (like radiologists interpreting images) is not applicable here. The "experts" would be microbiologists and technicians performing the tests. No specific number or qualifications are mentioned.

3. Adjudication method for the test set:

   • Not applicable in the sense of human adjudicators for subjective interpretations. The outputs (sterilization/non-sterilization, color change) are objective and determined by standard laboratory protocols.

4. 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:

   • No. This is not an AI-assisted diagnostic or interpretation device that would involve human readers.

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

   • Yes, in essence, this is a standalone performance study of a device. The biological indicator and chemical indicator are designed to provide an objective output (spore growth/no growth, color change) without human intervention in the interpretation process (beyond observing the result). The "algorithm" here is the biological and chemical reaction and spore death kinetics under sterilization conditions. The study confirms the performance of this "algorithm" in new sterilizer models.

6. The type of ground truth used:

   • Microbiological viability (absence/presence of Bacillus subtilis var. niger growth) for the biological indicator.
   • Chemical reaction/color change for the chemical indicator.
   • The ultimate ground truth is whether the sterilization process itself was effective at killing microorganisms. The BI is a direct measurement of this biological efficacy, and the chemical indicator is a process indicator.

7. The sample size for the training set:

   • This is not an AI/machine learning device; therefore, there is no "training set." The performance evaluation is based on experimental testing of the physical device.

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

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

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The STERRAD® BI Test Pack is intended to be used as a standard method for frequent monitoring of the STERRAD® 100 Sterilizer cycle*, It functions as a routine test pack with both a biological sterilization process indicator and a chemical process indicator.

Catalase Reagent is added to the Tryptic Soy Broth (TSB) medium, to neutralize the residual hydrogen peroxide on the biological indictor strip after sterilization.

• See precautionary statement in Instructions For Use concerning the use of this product with the STERRAD 50 Sterilizer which reads in part as follows:

NOTE: The Certificate of Performance that accompanies these BI Test Packs contains data from the STERRAD® 100 Sterilizer. This information is unique to the STERRAD® 100 Sterilizer. The initial validation data submitted, based upon varying hydrogen peroxide concentration in the STERRAD® 50 Sterilizer, indicate that the BI Test Pack is acceptable for use with the STERRAD® 50 Sterilizer. The final performance data (D-value and Survival/Kill times) are not yet complete. Updated performance data for the BI Test Pack in the STERRAD® 50 Sterilizer will be provided by ASP as soon as it is available.

The STERRAD® BI Test Pack (BI Test Pack) consists of a plastic tray with a clear top which contains a STERRAD® Biological Indicator paper strip containing 106 Bacillus subtilis var. niger spores, a STERRAD® BI Test Pack Indicator Strip and a length of latex tubing. The BI spore strip is packaged in a Tyvek/Mylar peel pouch to protect the spore strip during handling.

The narrow opening and channels leading to the interior of the BI Test Pack and the absorptive properties of the latex tubing provide a diffusion restrictive environment which contributes to the effective resistance of the indicator organism. Included with the BI Test Pack are individual BI spore strips in Tyvek/Mylar peel pouches to serve as positive controls in the microbiological testing.

The STERRAD® BI Test Pack Chemical Indicator Strip included in the Test Pack serves as a chemical process indicator (Class A per EN867-1) for the STERRAD® Sterilizer cycle, Exposure of the chemical indicator strip to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow.

The provided text describes a 510(k) submission for a modification to the STERRAD® BI Test Pack, primarily concerning a reduced incubation time for the biological indicator and the provision of a catalase reagent. The submission references a study to validate the reduced incubation time.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The core of the modification is the reduced incubation time for the STERRAD® BI Test Pack.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The study primarily focuses on validating the reduced incubation time of the biological indicator.

1. Sample Size used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document mentions that "partial sterilization cycles were based on decrease in diffusion and plasma time." It also states, "Three different spore lots, from three different spore crops, were used for this validation. Each test was performed using a different lot of media."
   • Data Provenance: Not explicitly stated, but given it's a submission to the FDA, it's implied that the testing was conducted by Advanced Sterilization Products (ASP), likely in the US, as part of their regulatory compliance. The study design followed the "CDRH Guidance Document Guide For Validation Of Biological Indicator Incubation Time (1986)," indicating adherence to US regulatory guidelines. The data is retrospective in the sense that the testing was completed prior to the submission.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

   • Not applicable to this type of device. The "ground truth" for a biological indicator is determined by the growth or non-growth of spores, which is a microbiological outcome, not an expert visual interpretation.

3. Adjudication Method for the Test Set:

   • Not applicable. The outcome (growth or no growth) is an objective, measurable biological phenomenon, not subject to human adjudication in the typical sense.

4. 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 a biological indicator device, not an AI-assisted diagnostic tool involving human readers.

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

   • Not applicable. This device does not involve an algorithm. The performance is the inherent biological response of the indicator.

6. The type of ground truth used:

   • Microbiological Outcome/Pathology: The ground truth is the actual viability (growth or no growth) of the Bacillus subtilis var. niger spores, determined through standard microbiological culture techniques after exposure to partial sterilization cycles. The 97% growth is the performance metric against this ground truth.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires "training data." The validation study uses a test set to confirm the performance of the biological indicator.

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

   • Not applicable, as there is no training set for this device.

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