(91 days)
The VERIFY Assert VH2O2 Self-Contained Biological Indicator is used for routine monitoring, and qualification of Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX, and 60 Low Temperature Sterilizers in healthcare facilities.
When used in conjunction with the VERIFY Incubator for Assert VH2O2 SCBI, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 20 minutes.
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, Incubator for VERIFY Assert VH2O2 Self-Contained Biological Indicator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.
The provided text describes the acceptance criteria and the summary of non-clinical tests for the "VERIFY Assert VH2O2 Self-Contained Biological Indicator". However, it's important to note that this document is for a biological indicator used in sterilization processes, not an AI/ML powered medical device for diagnostic purposes. As such, some of the requested information (like MRMC study, human reader improvement with AI, ground truth for training AI, etc.) is not applicable to this type of device.
Here's the information extracted and adapted where possible:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Reduced Incubation Time (RIT) Testing | Meets FDA's requirement of > 97% alignment of the 20-minute results with the conventional incubation time of 7 days | PASS |
| Viable spore population | 1.0 - 4.0 x 10^6 spore/SCBI | PASS |
| Resistance | D-value > 3 sec | PASS |
| Survival Time | Survival Time ≥ 4 sec | PASS |
| Kill Time | Kill Time ≤ 6 min | PASS |
| Carrier growth inhibition / media growth promotion | Positive growth of less than 100 spores after primary packaging and media are subject to worst-case VHP exposure | PASS |
| Hold Time | Performance not affected if incubated within 72 hours of exposure to VHP sterilization | PASS |
| Simulated Use | Demonstrate no growth when exposed to worst-case cycles | PASS |
2. Sample size used for the test set and the data provenance:
The document summarizes "non-clinical tests" but does not explicitly state the specific sample sizes for each test in the acceptance criteria table. It refers to "testing in accordance with FDA guidance for BI 510(k)" and "ISO 11138–1 media testing," which would imply standardized testing protocols that define sample sizes. Without further details of these specific tests, the exact sample sizes cannot be determined from the provided text.
The data provenance is not specified in terms of country of origin or explicit retrospective/prospective design. However, the tests are laboratory-based and conducted by the manufacturer, STERIS Corporation, in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to a biological indicator. The "ground truth" for a biological indicator is determined by the survival or inactivation of Geobacillus stearothermophilus spores under specific sterilization conditions, which is a microbiological and chemical measurement, not an expert human interpretation.
4. Adjudication method for the test set:
Not applicable, as the evaluation is based on objective microbiological and chemical results, not 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:
Not applicable. This device is a biological indicator for sterilization, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a "self-contained biological indicator" that produces a fluorescent result, which is then detected by an "automated incubator/reader." In this sense, the "algorithm" equivalent is the biological and chemical reaction within the indicator, and its detection by the automated reader. The performance described in the acceptance criteria is essentially its standalone performance in various conditions. There's no "human-in-the-loop" for the primary result generation, only for interpreting the automated reader's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used for testing this biological indicator is based on:
- Microbiological viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
- Chemical/Biological reactions: The enzyme reaction with a fluorogenic substrate to produce a fluorescent moiety, detected by the incubator.
- Standardized testing methods: Adherence to FDA guidance for BI 510(k) and ISO 11138–1 standards, which define the expected biological and chemical responses under controlled conditions (e.g., D-value, survival time, kill time).
8. The sample size for the training set:
Not applicable in the context of an AI/ML training set. This is a physical device, and its "performance" is inherent to its design and manufacture, validated through a series of non-clinical tests.
9. How the ground truth for the training set was established:
Not applicable in the context of an AI/ML training set. The "ground truth" for the device's development (if one were to call it that) would come from established principles of microbiology and sterilization science, as well as the performance characteristics of its constituent materials and biological components.
§ 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).