(44 days)
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
| Acceptance Criteria / Performance Characteristic | Reported Device Performance |
|---|---|
| No color reversion after growth | Color did not revert and yellow (positive) color was stable for up to seven days of incubation time. |
| Not bacteriostatic | Growth media was not bacteriostatic. |
| Maintains enough volume for positive growth | Growth media maintained enough volume to support positive growth. |
| Meets 24-hour incubation time | Test data confirmed the 24 hours incubation time. |
| Consistently supports growth of Geobacillus stearothermophilus | Test data confirmed growth support of the indicator organism (Geobacillus stearothermophilus). |
| Initial shelf life | Test results support eighteen months of shelf life. |
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.
§ 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).