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Use the 3MTM Attest™ Steam Chemical Integrator Test Pack 41360 to monitor:

• · 121°C (250°F) gravity displacement steam sterilization cycle at 30 minutes
• · 132°C (270°F) dynamic-air-removal steam sterilization cycle at 4 minutes
• · 135°C (275°F) dynamic-air-removal steam sterilization cycle at 3 minutes

3M™ Attest™ Steam Chemical Integrator Test Pack 41360 is specifically designed to routinely challenge the steam sterilization process in healthcare facilities. This convenient disposable process challenge device presents a challenge to the sterilization process equivalent to the 16towel process challenge device (PCD) recommended by the Associate for the Advancement of Medical Instrumentation (AAMI). Each test pack contains a process indicator on the outside that changes from yellow to brown or darker when steam processed.

Each pack contains a 3M™ Attest™ Steam Chemical Integrator and a record keeping sheet. The 3MTM Attest™ Steam Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. When exposed to steam sterilization conditions, the chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked REJECT or ACCEPT. The extent of migration depends on steam, time, and temperature.

The provided document describes the 3M™ Attest™ Steam Chemical Integrator Test Pack 41360. Based on the information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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 exact sample size for the test set. It only states that "Performance testing to demonstrate substantial equivalence to the predicate device has been completed." The data provenance is not explicitly mentioned but is implied to be from 3M Company's internal testing as part of their premarket notification for the FDA. This would generally be considered prospective testing in a controlled laboratory environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the device described. The device is a chemical indicator for steam sterilization. Its performance is evaluated against established physical and chemical standards (like AAMI ST79) and other devices, rather than being assessed by human experts interpreting results.

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

This is not applicable. The performance testing involves objective measures of resistance to sterilization conditions, not subjective interpretations 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

This is not applicable. The device is a physical chemical indicator, not an AI or imaging diagnostic tool.

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

This is not applicable. The device is a physical chemical indicator. Its performance is inherent to its design and chemical properties.

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

The ground truth for the performance testing is based on established industry standards for steam sterilization and chemical indicators, specifically:

• ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
• ISO 11140-1:2014 Sterilization of health care products – Chemical indicators, Part 1: General Requirements

The ground truth for "resistance" is defined by these standards and the behavior of the AAMI 16 Towel Process Challenge Device (PCD) and a Biological Indicator.

8. The sample size for the training set

This is not applicable. The device is not an AI or machine learning model that requires a training set. The development of such physical indicators involves engineering, chemistry, and iterative testing, not "training" in the AI sense.

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

This is not applicable for the reasons stated above.

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