(302 days)
The Once-A-Day® Vertos™ Test Pack is an air removal indicator that is intended to be used by a health care provider as a standardized test pack, e.g., Bowie Dick Test Pack, to assess the ability of a pre-vacuum sterilizer to remove air and allow steam to penetrate into wrapped goods and porous loads operating at 134° C using a 3.5 minutes exposure time. The Once-A-Day® Vertos™ Test Pack is directed to be positioned on the lowest shelf over the chamber drain in an otherwise empty chamber. An unexposed test pattern is uniformly blue and a uniform pink test pattern represents an acceptable cycle. The Once-A-Day® Vertos™ Test Pack is not an indication that the sterilizer has reached the parameters for sterilization.
The Once-A-Day® Vertos™ Test Pack is a Bowie & Dick type test for prevacuum steam sterilizers that complies with requirements of AAMI/ANSI/ISO 11140-1:2005 as class 2 indicator, which includes conformance with the labeling requirements and general requirements on the performance. The pack also complies with requirements of AAMI/ANSI/ISO 11140-5:2007, which includes the test format parameters, performance at 134° C for 3.5 min in Pass and Fail cycles, dry heat test parameters, ink transfer limitations, labeling requirements, and all normative described in annexes.
The provided text is a 510(k) summary for the Once-A-Day® Vertos™ Test Pack, a chemical sterilization process indicator. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about a specific study with acceptance criteria, test set sample size, expert qualifications, or adjudication methods in the way a clinical trial or AI performance study would. It focuses on the device's conformance to ISO standards.
Based on the provided text, here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the device complies with specific ISO standards, which inherently include performance criteria. The performance is described in terms of color change.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to AAMI/ANSI/ISO 11140-1:2005 as Class 2 indicator | Complies with requirements, including labeling and general performance. |
| Conformance to AAMI/ANSI/ISO 11140-5:2007 | Complies with requirements, including test format, performance at 134°C for 3.5 min in Pass and Fail cycles, dry heat test parameters, ink transfer limitations, labeling, and normative annexes. |
| Unexposed test pattern color | Uniformly blue. |
| Acceptable cycle test pattern color | Uniformly pink. |
| Incomplete change in air removal indicator | Uneven color change (indicates inefficient air removal, air leak, or non-condensable gases). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: This information is not provided in the document. The document states compliance with ISO standards, which would imply testing, but not the specific sample size used for those tests.
- Data Provenance: This information is not provided. The testing would have been conducted by the manufacturer, but specific details on where or how are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The device's performance is based on chemical reactions and color interpretation, likely validated against physical/chemical references as defined by the ISO standards, rather than expert human interpretation of complex medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of a chemical indicator, adjudication methods typical for subjective human interpretation (like in imaging studies) are not applicable. The assessment would be objective, based on color change.
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:
- No, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI-assisted diagnostic tools, not for a chemical sterilization indicator. The device is not an AI product.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This question is not applicable as the device is a chemical indicator, not an algorithm or AI system. Its performance is inherent to its physical and chemical properties. Operators simply observe the color change.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this device is based on physical and chemical parameters defined by international standards (AAMI/ANSI/ISO 11140-1:2005 and 11140-5:2007) for steam sterilization. This includes precisely defined "Pass" and "Fail" cycle conditions at specific temperatures and exposure times (e.g., 134°C for 3.5 minutes). The color change observed in the indicator is then correlated to these established physical parameters representing effective air removal and steam penetration.
8. The sample size for the training set:
- This concept is not applicable as the device is not an AI or machine learning system that requires a training set.
9. How the ground truth for the training set was established:
- This question is not applicable for the same reason as point 8.
§ 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).