(206 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Survival Characteristics: The biological indicator (BI) should accurately demonstrate survival when exposed to conditions that do not achieve sterilization in the STERRAD® 50 and STERRAD® 100S Sterilizers. | The study generated new "Survival characteristics" for the STERRAD® BI Test Pack in the STERRAD® 50 and STERRAD® 100S sterilizers. The results were found to be "accurate and reproducible." The intent is that these new characteristics allow the pack to function as a reliable biological sterilization process indicator for these sterilizers. |
| Kill Characteristics: The BI should accurately demonstrate kill when exposed to conditions that achieve sterilization in the STERRAD® 50 and STERRAD® 100S Sterilizers. | The study generated new "Kill characteristics" for the STERRAD® BI Test Pack in the STERRAD® 50 and STERRAD® 100S sterilizers. The results were found to be "accurate and reproducible." The intent is that these new characteristics allow the pack to function as a reliable biological sterilization process indicator for these sterilizers. |
| Reproducibility: The Survival and Kill data should be consistent across different manufacturing lots of the STERRAD® BI Test Packs. | Testing was conducted to show that the Survival and Kill Performance Data was "accurate and reproducible using three different manufacturing lots of STERRAD BI Test Packs." |
| Chemical Indicator Functionality: The chemical process indicator within the test pack should change color appropriately upon exposure to the STERRAD® 50 and STERRAD® 100S Sterilizer cycles. | The text states, "Exposure of the chemical indicator strip to the STERRAD® Sterilizer cycle results in a recognizable color change from red to yellow." While specifically mentioning STERRAD® Sterilizer (singular), the context implies this functionality extends to the new models if the pack is to be effective with them. No specific performance data for the chemical indicator in the new models is explicitly presented as being newly tested in this submission, but its consistent function is assumed for the overall test pack to be effective. |
Study Details
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).