(94 days)
Use the VERIFY® Incubator for Assert™ Self Contained Biological Indicators SCBI (Incubator) to incubate and automatically read VERIFY Assert Self-Contained Biological Indicators at 57 °C for a fluorescent result within 40 minutes.
The VERIFY® Incubator for Assert™ Self Contained Biological Indicators (Incubator) is an incubator/reader designed for use specifically with the VERIFY Assert Self-Contained Biological Indicator (SCBI), see K162701, currently under review. The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the SCBI is detected by the incubator/reader and indicates the presence of viable test microorganisms.
The document provided describes the "VERIFY® Incubator for Assert™ Self Contained Biological Indicators" and its nonclinical testing to demonstrate substantial equivalence to a predicate device. This device is an incubator/reader used to incubate and automatically read self-contained biological indicators for sterilization processes.
Here's a breakdown of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance (Conclusion) |
|---|---|---|
| Maintenance of Incubation Temperature | Maintain 55-60 °C for a minimum of 40 minutes (incubation time of Verify Assert SCBI as stated in K162701) | PASS |
| Qualification testing with Verify Assert SCBI | 40-minute fluorescent read meets >97% alignment with 7-day growth results per FDA guidance on reduced incubation time. | PASS |
| Qualification testing with Verify Assert SCBI | Pass testing with SCBI exposed to full cycle exposure and negative growth result in incubator. | PASS |
| Qualification testing with Verify Assert SCBI | Fail testing with SCBI exposed in abbreviated cycle exposure and positive result in incubator. | PASS |
| Alarm, LED and Print function Test | Demonstrate proper function of alarms, LED and print outputs. | PASS |
Study Proving the Device Meets Acceptance Criteria:
The document describes nonclinical performance testing.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the specific number of biological indicators (sample size) used for the qualification testing. It refers to "testing with SCBI exposed to full cycle exposure" and "testing with SCBI exposed in abbreviated cycle exposure," implying multiple indicators were tested.
- Data Provenance: The document doesn't specify the country of origin for the data. Given it's a submission to the FDA (United States), it is highly likely the testing was conducted in the USA or by a facility adhering to US regulations. The testing is described as "performance testing," which typically refers to prospectively collected data for validation purposes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is an incubator/reader for biological indicators. The "ground truth" for this type of device is the actual growth or non-growth of microorganisms in the biological indicator, determined through traditional microbiological culturing methods (e.g., 7-day growth results for biological indicators). There is no mention of human experts (like radiologists) being involved in establishing the ground truth for this specific device, as its function is to automate the reading of a biological indicator. The "7-day growth results" serve as the objective ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. The ground truth is based on the biological end-point (microbial growth/no growth), not subjective human interpretation requiring 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 an automated incubator/reader for biological indicators, not an AI-assisted diagnostic imaging device that involves human reader interpretation. No human readers are involved in the "reading" process of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, this is effectively a standalone performance study. The device itself (the incubator/reader) provides the fluorescent read, which is then compared against the established biological "truth" (7-day growth results). Its primary function is automated reading without human interpretation of its output beyond acknowledging the alarm or visual indicator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth used is the microbiological growth status of the biological indicators, specifically the "7-day growth results." This is an objective measurement of whether the microorganisms in the biological indicator proliferated or not, which is the definitive indicator of sterilization effectiveness.
8. The sample size for the training set:
Not applicable. This document describes a traditional medical device (an incubator/reader) validated through performance testing, not a machine learning or AI-based device that typically requires a separate training set. The device's "knowledge" is built into its design (temperature control, fluorescence detection) rather than learned from a data set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned for this type of device.
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