(12 days)
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.
| Cycle Type | Temperature | Time |
|---|---|---|
| Dynamic Air Removal | 270°F (132°C) | 4 minutes |
| Dynamic Air Removal | 275°F (135°C) | 3 minutes |
| Gravity | 250°F (121°C) | 30 minutes |
| Gravity | 270°F (132°C) | 15 minutes |
When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes
The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, VERIFY Incubator for Assert Self-Contained Biological Indicator, in 40 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. 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 document, a 510(k) premarket notification for the VERIFY Assert Self-Contained Biological Indicator, details the device's technical characteristics and nonclinical testing. However, it does not describe a study involving an AI-powered medical device or human readers. Therefore, much of the requested information cannot be extracted from this specific document.
Here's the information that can be extracted or inferred based on the document's content, formatted as requested:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use | BI is inactivated when exposed in a worst-case cycle with a worst-case load | No growth of BI |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the "Simulated Use" test, nor does it provide details about the data provenance (e.g., country of origin, retrospective/prospective). It only states that performance testing "has been completed" and is summarized.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a biological indicator for sterilization, not an imaging or diagnostic device requiring expert review for ground truth. The "ground truth" for this device's function is the biological outcome (growth or no growth of the biological indicator) after exposure to sterilization conditions.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There's no human interpretation or adjudication described for the biological indicator's performance. The outcome is a direct biological observation (fluorescence, indicating growth, or lack thereof).
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 document describes a biological indicator, not an AI-powered device or a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a biological indicator. Its operation involves a "VERIFY Incubator for Assert Self-Contained Biological Indicator" which detects a fluorescent result, suggesting an automated readout. However, this is not an "algorithm only" performance in the context of AI without human-in-the-loop diagnosis or interpretation. The device itself is the indicator, and the incubator provides an automated reading of its state.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device's performance is the biological outcome: inactivation (no growth) of the Geobacillus stearothermophilus spores after exposure to sterilization conditions, or growth when not adequately sterilized. This is determined by observing fluorescence, which indicates enzymatic activity from viable spores.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device that requires a training set.
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