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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.

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The VERIFY™ ASSERT™ STEAM Process Challenge Device for Gravity Cycles is used for qualification, routine microbial monitoring, and cycle monitoring of steam sterilizers.

The validated steam sterilization cycles include:

• · 250°F (121°C) 30-minute gravity
• · 270°F (132°C) 15-minute gravity

The VERIFY Assert Self-Contained Indicator within the Process challenge device must be used with the VERIFY Incubator for Assert Self Contained Biological Indicators. When used in conjunction with the VERIFY Incubator for Assert Self Contained Biological Indicators, the VERIFY Assert Self-Contained Indicator within the Process challenge device provides a fluorescent result within 40 minutes.

The VERIFY"" Assert" |STEAM Process Challenge Device for Gravity Cycles (Gravity PCD), contains a VERIFY Assert Self-Contained Biological Indicator (SCBI) and a steam chemical integrator, sealed within a plastic tray with foil cover. The tray has a molded channel which serves as the tortuous pathway for air removal/steam penetration during steam sterilization. The PCD is designed and validated to be equivalent to the standard 16-towel test pack described in ANSI/AAMI ST79.

The STERIS VERIFY™ Assert™ STEAM Process Challenge Device for Gravity Cycles does not involve AI or human readers, therefore, many of the requested categories are not applicable.

Here's a summary of the acceptance criteria and study information for this device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each test. However, it indicates "Simulated use testing was done side-by-side with the predicate device". The data provenance is derived from these non-clinical tests conducted by STERIS Corporation. The data is prospective as it describes testing specifically designed for the device's clearance.

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 sterilization process challenge device, not a diagnostic or AI-powered medical device requiring expert interpretation of results. The "ground truth" is based on the inactivation of biological indicators and the chemical changes in integrators under controlled sterilization conditions, in comparison to an established standard (AAMI reference pack).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. The tests involve quantifiable outcomes (e.g., biological indicator inactivation, chemical integrator endpoint attainment) rather than subjective 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 is not an AI-powered device or a device involving human readers.

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

The device's performance is inherently "standalone" in the sense that it functions to indicate sterilization efficacy without human interpretation of complex data or algorithms. Its results (fluorescent or non-fluorescent, chemical change) are read by an automated incubator/reader for the BI and visually for the chemical integrator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The ground truth is established based on:

• Biological Inactivation: The complete inactivation of Geobacillus stearothermophilus spores within the biological indicator, as confirmed by the absence of fluorescence after incubation. This aligns with standard microbiological principles for sterilization efficacy.
• Chemical Integrator Response: The visible change in the chemical integrator, indicating exposure to specific sterilization parameters (time, temperature, steam).
• Comparison to AAMI Reference Pack: The performance of the VERIFY™ Assert™ PCD is compared against the "standard 16-towel test pack described in ANSI/AAMI ST79," which serves as a recognized gold standard for validating sterilization processes.

Essentially, the "ground truth" is a set of established physical and biological parameters for effective steam sterilization.

8. The sample size for the training set:

Not applicable. This device does not use machine learning or require a training set.

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

Not applicable. No training set was used.

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