(120 days)
The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles.
STERRAD® CYCLESURE® 24 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 108 CFU of 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.
The provided 510(k) summary describes a biological indicator, not an AI/ML powered medical device. Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training data) do not apply to this submission.
However, I can still extract the acceptance criteria and performance data for the biological indicator and address the relevant points from your request.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list quantitative acceptance criteria in a table format with corresponding numerical performance metrics for each criterion in the manner typically seen for AI/ML device performance. Instead, it lists validation studies that were conducted and reports a "Passed" status for each. This indicates that the device met the internal specifications or established thresholds for each validation study.
| Validation Study | Acceptance Criteria (Implied / Qualitative) | Reported Device Performance |
|---|---|---|
| Evaporation | Device resists evaporation to an acceptable degree (specific threshold not provided). | Passed |
| Verification of Positive BI Color | The biological indicator consistently displays a positive color change when growth occurs. | Passed |
| Bacteriostasis | Device does not inhibit the growth of microorganisms when they are present and should grow. | Passed |
| Verification of Minimum Incubation Time | Spore growth (and indicator change) is accurately detected within the specified minimum incubation time. | Passed |
| Spore Resistance | Geobacillus stearothermophilus spores exhibit expected resistance to the sterilant. | Passed |
| BI Validation in STERRAD Sterilizers | The biological indicator accurately reflects the efficacy of STERRAD sterilizer cycles (Dose Response). | Passed |
| Growth Promotion | The growth medium effectively promotes the growth of microorganisms (spores) when viable. | Passed |
Study Details (as applicable to a biological indicator)
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of BIs) used for each validation study. The data provenance is internal to Advanced Sterilization Products, Division of Ethicon, Inc., and the studies appear to be prospective validation tests conducted by the manufacturer to demonstrate the device's performance. No country of origin for "data" in the context of clinical populations is relevant here as it's a lab-based performance validation study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device where expert interpretation determines ground truth for a test set. The "ground truth" for a biological indicator is based on microbiological growth or non-growth under controlled conditions, which are objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation or diagnosis in AI studies. For a biological indicator, the outcome (growth or no growth, color change) is a direct, observable, and quantifiable result of a controlled microbiological experiment.
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 is not an AI/ML device, so no MRMC study involving human readers and AI assistance was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a standalone biological indicator, not an algorithm. Its "standalone performance" is its ability to accurately indicate the presence or absence of sterilizing conditions based on microbial viability. The validation studies listed (e.g., Evaporation, Growth Promotion, Spore Resistance) represent its standalone performance characteristics.
7. The type of ground truth used
The ground truth used for these validation studies is microbiological growth/viability or physical/chemical property verification. For instance:
- For "Verification of Positive BI Color" and "Growth Promotion," the ground truth is the actual presence and growth of viable Geobacillus stearothermophilus spores.
- For "Spore Resistance" and "BI Validation in STERRAD Sterilizers," the ground truth is the known exposure to sterilant and the expected survival/kill rate of the spores.
- For "Evaporation" and "Bacteriostasis," the ground truth relates to the integrity and functional properties of the device under test conditions.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, and therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML 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).