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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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The 3M Attest™ 390 Auto-reader is designed to incubate and automatically read the 3M Attest™ Rapid Readout Biological Indicators for Steam, 1291 and 1292, at 60°C for a final fluorescent result at 1 hour for 1291 and 3 hours for 1292.

The 3M Attest™ 390G Auto-reader is designed to incubate and automatically read the 3M Attest™ Rapid Readout Biological Indicator for Ethylene Oxide, 1294, at 37°C for a final fluorescent result at 4 hours.

The Attest™ 390 and 390G Auto-readers are used in conjunction with Attest™ Rapid Readout Biological Indicators by trained personnel in central sterilization departments to monitor sterilization processes. The 390 and 390G Auto-readers, like its predecessors the Attest™ 290, 290G and 490 Auto-readers, have two functions. First, the devices serve to incubate the biological indicator (BI) at the temperature appropriate to the organism. Second, the devices determine whether a potential sterilization failure may have occurred by measuring the intensity of fluorescence produced by an enzymatic reaction associated with spore growth inside the selfcontained biological indicator.

The 390 and 390G Auto-readers include a Crusher Well in which the Attest™ Rapid Readout biological indicators are activated. After activation, the user places the biological indicator into one of the 10 color-coded Incubation Wells. The 390 and 390G Auto-readers have an incubation block controlled to the appropriate temperature for their respective biological indicators. The Auto-readers contain a LCD panel that shows the time remaining for incubation. Fluorescence detection at each incubation well is accomplished by the use of a UV LED and a photo diode sensor. As soon as a positive result is detected, a '+' sign is shown as an indication of sterilization cycle failure, accompanied by an audible alarm. At the end of the specified incubation time, if a negative result is detected, a '-' sign is shown on the LCD panel as indication of an adequate sterilization cycle. When the test is complete, as indicated by the (+) or (-) symbol on the Auto-reader LCD panel under the incubating BI, the customer records the result and disposes of the biological indicator.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the exact sample size (number of biological indicators or test runs) used for the qualification testing. It only mentions "Multiple lots of 3M Attest™ Rapid Readout biological indicators were evaluated for performance."
• Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification for submission to the FDA, suggesting the evaluation was conducted for US regulatory purposes. The data is presented as retrospective in the sense that the testing was completed prior to the submission for regulatory approval.

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

The concept of "experts" and "ground truth" in the typical AI/medical device context (e.g., radiologists interpreting images) does not directly apply here. The device being evaluated is an auto-reader for biological indicators (BIs) used to monitor sterilization processes.

• Ground Truth Establishment: The ground truth for the biological indicator performance testing is established by comparing the rapid readout results (fluorescent result at 1, 3, or 4 hours) to the "conventional incubation time of 7 days." This conventional incubation time is the established method for determining sterility failure or success, and the biological indicators themselves are a well-defined standard for monitoring sterilization.
• Experts: No external human experts are mentioned as establishing this ground truth. The "ground truth" for BI performance is inherent in the established standard for biological indicator readout over 7 days.

4. Adjudication Method for the Test Set:

Not applicable in the traditional sense. The "adjudication" (comparison) is automated: the device's rapid fluorescent result is compared to the established 7-day conventional incubation result for the biological indicators. The acceptance criteria specify a "> 97% alignment" for this comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices where human interpretation directly impacts the outcome (e.g., diagnostic imaging). This device is an auto-reader for biological indicators, where the primary function is automated detection of fluorescence and temperature maintenance. There's no human "reader" in the loop for the primary function being tested for performance against the acceptance criteria.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, a standalone study was performed. The entire evaluation described is of the automated device (the 3M Attest™ 390 and 390G Auto-readers) in conjunction with its respective biological indicators. The device functions automatically to incubate, read fluorescence, and provide a positive/negative result without human intervention in the interpretation of the BI's sterility status.

7. Type of Ground Truth Used:

The ground truth used is based on established standard biological indicator performance (conventional 7-day incubation results) and physical measurement standards (temperature maintenance, electrical safety, EMC). Specifically, for BI qualification, it is a comparison against the long-standing 7-day incubation period result, which serves as the "gold standard" for determining bacterial growth in the BI.

8. Sample Size for the Training Set:

The document does not provide any information regarding a "training set" or its sample size. This is expected because the device likely operates based on a fixed algorithm for fluorescence detection and temperature control, rather than a machine learning model that would require a dedicated training phase. The device's performance is validated against established biological indicator principles.

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

Not applicable. As no training set is mentioned or implied for a machine learning model, there is no ground truth established for a training set. The device follows pre-defined detection parameters and physical controls.

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