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Use the 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382 to qualify or monitor:
· 121°C (250°F) 30-minute gravity steam sterilization cycles;
· 132°C (270°F) 4-minute dynamic-air-removal steam sterilization cycles.

The 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382 is specifically designed to qualify and monitor 250°F (121°C) gravity and 270°F (132°C) dynamic-air-removal steam sterilization processes in healthcare facilities. The test pack consists of multiple layers of medical index cards, some of which are die-cut to contain the monitoring products. Each test pack has a process indicator on the pack label that changes from yellow to brown or darker when exposed to steam. This convenient disposable test pack presents a challenge to the sterilization process equivalent to the user-assembled biological indicator (BI) challenge test pack (16-towel PCD) recommended by the Association for the Advancement of Medical Instrumentation (AAMI). The test pack is a single use device.

Each test pack contains a 3M™ Attest™ Rapid Readout Biological Indicator 1292 (brown cap, hereinafter referred to as a 1292 BI), a 3M™ Attest™ Steam Chemical Integrator, and a record keeping sheet. AAMI recommends that steam sterilization loads containing an implant be monitored with a process challenge device (PCD) containing a biological indicator and an integrating indicator. 3MTM Attest™ Steam Chemical Integrators are Type 5 (Category i5) Integrating Indicators as categorized by ISO 11140-1:2014. 3M™ Attest™ Steam Chemical Integrators are single-use chemical indicators consisting of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a green window marked ACCEPT or a red window marked REJECT; the extent of migration depends on steam, time, and temperature. The 3MTM AttestTM Steam Chemical Integrator offers an immediate Accept/Reject reading that allows for implant load early release in emergency situations as defined in AAMI ST-79.

3M™ Attest™ Rapid Readout Biological Indicators 1292 comply with the requirements of ISO 11138-1:2017 and ISO 11138-3:2017. The 1292 BI is a dual readout biological indicator specifically designed for rapid and reliable monitoring of steam sterilization process when used in conjunction with the 3MTM Attest™ 290 Auto-reader or the 3M™ Attest™ Auto-reader 390. When steam processed, the process indicator on the 1292 BI label changes from rose to brown/black. Control 1292 BIs are provided with the test packs.

The 1292 BI detects the presence of Geobacillus stearothermophilus by detecting the activity of alpha-glucosidase, an enzyme present within the organism. The presence of the enzyme is detected by reading fluorescence produced by the enzymatic breakdown of a non-fluorescent substrate. This creates a fluorescence change, which is detected by the auto-reader. A fluorescence change indicates a steam sterilization process failure.

The 1292 BI can also indicate the presence of G. stearothermophilus organisms by a visual pH color change reaction. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media to change color from purple to yellow, which also indicates a steam sterilization process failure. Use of this indication method is optional and is typically restricted to special studies. Due to the high sensitivity of the 3-hour fluorescent results, however, there is no advantage to incubating the 1292 BI beyond 3 hours.

The provided text describes the 3M™ Attest™ Rapid 5 Steam-Plus Test Pack 41382 and its non-clinical testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each test. It refers to "non-clinical tests" and "testing was conducted" without detailing the number of units tested. The data provenance is implied to be from 3M Company's internal testing facilities, as it's a submission for their device. The information indicates these are likely prospective laboratory studies, rather than retrospective human data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided. The testing described focuses on the physical and biological characteristics of a sterilization indicator, comparing it to established standards (AAMI, ISO, USP) and a predicate device. The determination of "ground truth" for these tests would likely involve adherence to standardized testing protocols and measurement techniques rather than expert consensus on a subjective result.

4. Adjudication Method:

This information is not provided. Given the nature of the tests (comparing resistance to established standards), the results (Pass/Fail) are likely determined directly by the adherence to and outcome of standardized protocols, rather than through an adjudication process involving multiple human reviewers.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices evaluated by human readers (e.g., imaging devices) where the impact of AI on human performance is assessed. The subject device is a biological/chemical indicator for sterilization, not an AI-powered diagnostic tool requiring human interpretation.

6. Standalone (Algorithm Only) Performance Study:

Yes, in essence, the non-clinical tests described represent a standalone performance evaluation of the device itself. The "algorithm" here is the physical and biological response of the indicator to sterilization conditions. The tests aim to demonstrate that the device, on its own, meets the specified resistance and performance criteria when exposed to controlled conditions.

7. Type of Ground Truth Used:

The ground truth used for the testing falls under established standards and objective measurements.

• For the "Comparison to AAMI 16 Towel PCD" test, the ground truth is the defined resistance characteristics of the AAMI ST79 16-Towel PCD.
• For the "Comparison to Biological Indicator" test, the ground truth is the inherent resistance of the Biological Indicator alone, as determined by standardized methods.
• More broadly, the acceptance criteria are based on recognized industry standards like ANSI/AAMI ST79, ISO 11138-1, ISO 11138-3, ISO 11140-1, and United States Pharmacopeia chapters.

8. Sample Size for the Training Set:

This information is not applicable and therefore not provided. The device is a physical sterilization indicator, not an AI or machine learning model that requires a "training set" in the conventional sense. Its performance is based on its physical and biological design and manufacturing consistency.

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

This information is not applicable as there is no "training set" for this type of device. The device's fundamental function is based on established scientific principles of microorganism inactivation and chemical reactions under specific sterilization conditions, verified through empirical testing against standards.

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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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