(116 days)
The STERRAD® CYCLESURE® Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:
| MODEL | CYCLE |
|---|---|
| STERRAD® 100S | Standard |
| STERRAD® 50 | Standard |
| STERRAD® 200 | Standard |
| STERRAD® NX™ | Standard |
| Advanced | |
| STERRAD®100NX™ | Flex |
| EXPRESS |
The STERRAD® CYCLESURE® 24 Biological Indicator is a self-contained standalone 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 the validation of the STERRAD® CYCLESURE® 24 Biological Indicator. However, it does not involve an AI device, therefore many of the requested categories are not applicable.
Here's the information extracted from the provided text, with clarification regarding the inapplicability of AI-specific questions:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document states "Performance testing demonstrated that the STERRAD® CYCLESURE® 24 Biological Indicator performs as intended in a newly developed STERRAD® 100NX™ Express Cycle." Specific quantitative acceptance criteria are not detailed in the provided text. The performance data is presented qualitatively as "Passed" for each study.
| Study Performed | Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|---|
| Evaporation | Not explicitly stated | Passed |
| Verification of positive BI color | Not explicitly stated | Passed |
| Bacteriostasis | Not explicitly stated | Passed |
| BI validation in STERRAD® 100NX™ Express Cycle (Dose Response) | Not explicitly stated | Passed |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size for each test.
- Data Provenance: The testing was conducted by Advanced Sterilization Products, a division of Ethicon, Inc. The data is from nonclinical laboratory tests rather than human patient data, therefore country of origin and retrospective/prospective distinctions are not applicable in the typical sense for medical imaging or AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This question is not applicable. The device is a biological indicator for sterilization. Its "ground truth" is determined by microbiological and chemical validation methods, not by expert interpretation of images or clinical data.
4. Adjudication method for the test set:
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of data, typically in studies involving human interpretation or clinical outcomes. This device's performance is assessed through laboratory testing.
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 question is not applicable. This is not an AI device, and an MRMC study is not relevant to its validation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This question is not applicable. This is not an AI algorithm. The device, a biological indicator, operates independently of human interpretation for its primary function (indicating sterilization efficacy), though humans read the results. The "standalone" concept for an AI algorithm doesn't apply here.
7. The type of ground truth used:
The ground truth for a biological indicator is established through:
- Microbiological assays: Verification of spore kill (or survival) based on established protocols for sterilization efficacy testing (e.g., D-value, Z-value determinations for sterilization resistance).
- Chemical indicator changes: Visual color changes indicating exposure to sterilant.
- Growth medium changes: Observation of growth/no-growth in sterile culture, indicating spore survival or kill.
The document refers to "BI validation in STERRAD® 100NX™ Express Cycle (Dose Response)" which implies methods to determine logarithmic reduction of spores, a standard ground truth for biological indicator performance.
8. The sample size for the training set:
This question is not applicable. This is not an AI device, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
This question is not applicable, as there is no "training set" for this 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).