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The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization processes.

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 STERIS Corporation VERIFY Assert Self-Contained Biological Indicator (SCBI) is a Class II device (21 CFR 880.2800, Product code FRC) intended for monitoring steam sterilization processes.

Here's an analysis of its acceptance criteria and the study proving its performance:

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• *: Based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions
• **: Minimum acceptance criteria based on recommendations in FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions
• ‡: Based on specifications of the reference device, VERIFY Assert Self-Contained BI

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes used for each non-clinical test (e.g., number of SCBIs tested for RIT, viable spore population, etc.). It only provides the acceptance criteria and the conclusion (PASS) or the measured performance range.

The data provenance is from non-clinical testing conducted by STERIS Corporation for their VERIFY Assert Self-Contained Biological Indicator. This would inherently be prospective data collection as it's part of a device validation study. The country of origin of the data is not specified, but the applicant (STERIS Corporation) is based in Mentor, Ohio, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This device is a biological indicator for sterilization processes. The "ground truth" for its performance is established through laboratory testing against well-defined, standardized sterilization parameters and biological growth assessment, rather than expert human interpretation of images or clinical data. Therefore, the concept of "experts establishing ground truth for a test set" in the context of interpretation of results (like in a medical imaging AI study) does not directly apply here. The "experts" involved would be the microbiologists and engineers who designed, executed, and analyzed the validation studies, ensuring adherence to standards like those outlined in FDA guidance documents and AAMI. Their qualifications would typically involve expertise in microbiology, sterilization science, and quality assurance for medical devices.

4. Adjudication method for the test set

Not applicable. As explained above, the "ground truth" is determined by objective biological and physical measurements and adherence to established scientific and regulatory standards for sterilization indicators, not by a panel of human adjudicators.

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, not an AI-powered diagnostic tool requiring human interpretation. Its function is to provide an objective fluorescent signal detected by a reader to indicate sterilization success or failure.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a way. The performance testing described is essentially a "standalone" assessment of the device's ability to accurately indicate sterilization conditions. The VERIFY Assert SCBI, when used with its proprietary reader, provides a fluorescent result within 40 minutes. This means the device itself, in conjunction with its automated reader, generates the result without human interpretation of a complex output. The human role is to observe the positive or negative signal from the reader. The tests confirm the device's intrinsic biological resistance and signal generation properties under various sterilization conditions and incubation parameters.

7. The type of ground truth used

The ground truth used for this device is based on:

• Microbiological Growth Assessment: Direct observation of bacterial growth (or lack thereof) after exposure to sterilization cycles, often confirmed by conventional incubation methods (e.g., 7 days of incubation) to establish true viability.
• Physical and Biological Standards: Adherence to established performance metrics ($D_{value}$, spore population) defined by regulatory guidance (FDA Guidance Biological Indicator (BI) Premarket Notification [510(k)] Submissions) and industry consensus standards (e.g., AAMI for sterilization processes).
• Controlled Sterilization Cycles: Exposure to precisely controlled steam sterilization cycles (e.g., abbreviated cycles to show growth, full cycles to show kill) to challenge the BI.

8. The sample size for the training set

Not applicable. This device is a biological indicator and does not employ machine learning or AI algorithms that would require a "training set." Its biological and chemical principles of operation are deterministic, based on the survival and metabolic activity of a target microorganism.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" for this type of device.

Ask a specific question about this device

The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.

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

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.

Ask a specific question about this device

The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.

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, Incubator for VERIFY Assert Self-Contained Biolgoical 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 document describes the VERIFY Assert Self-Contained Biological Indicator (SCBI) for monitoring steam sterilization processes. The acceptance criteria and testing are detailed for this device.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document is a 510(k) summary for a medical device (Biological Indicator) and lacks specific information regarding studies involving AI, human readers, or image analysis. Therefore, the following sections will indicate that the information is not applicable based on the content.

2. Sample Size Used for the Test Set and Data Provenance:

The document describes performance testing for biological indicators used in sterilization. It does not refer to "test sets" in the context of AI/machine learning or human reader studies. The data provenance is laboratory testing related to the performance of biological indicators under specific conditions rather than patient data. Specific sample sizes for each test are not explicitly detailed in the summary, but the resistance and population values are quantitative measurements of the device itself rather than data collected from a large number of 'samples' in the sense of a clinical trial. The testing is likely prospective and conducted in a controlled laboratory environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. This device is a biological indicator, and its performance is determined through standardized laboratory tests (e.g., spore count, D-value determination, growth/no growth observation) rather than interpretation by human experts.

4. Adjudication Method for the Test Set:

Not applicable. The determination of device performance (e.g., whether spores are killed, whether a fluorescent signal is produced) is based on objective laboratory measurements and biological principles, 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 document pertains to a biological indicator for sterilization monitoring, not an AI-powered diagnostic or interpretive device involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. The device itself is a biological indicator. Its "performance" involves a chemical/biological reaction monitored by a specific reader, but this is not an "algorithm" in the context of standalone AI performance. The reader provides a fluorescent result.

7. The Type of Ground Truth Used:

The ground truth for the device's performance is established by:

• Biological Viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
• Fluorescent Signal: The detection of a fluorescent moiety produced by the organism's enzyme reacting with a substrate, indicating viability.
• Standardized Test Methods: Adherence to established standards like ISO 11138 and FDA guidance for biological indicators.
• Quantitative Measurements: D-values (decimal reduction time), survival time, kill time, and spore population counts based on microbiological assays.

8. The Sample Size for the Training Set:

Not applicable. This document does not describe an AI/machine learning model that requires a training set. The device is a physical biological indicator.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as no training set for an AI model is described.

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