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The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer:

| 250°F/121°C
16.5 Minutes | 270°F/132°C
2.0 Minutes | 273°F/134°C
1.4 Minutes | 275°F/135°C
1.2 Minutes |
|-----------------------------|----------------------------|----------------------------|----------------------------|

3M™ Attest™ Steam Chemical Integrators are 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 window marked ACCEPT or window marked REJECT; the extent of migration depends on steam, time, and temperature.

Here's a breakdown of the acceptance criteria and the study information for the 3M™ Attest™ Steam Chemical Integrators, 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

The document states that the testing was performed on the 3M™ Attest™ Steam Chemical Integrators, which are identical to previously cleared devices (K193254) and were tested using "identified test methodology". However, the specific sample sizes used for each test criterion in the current submission's test set are not explicitly mentioned.

The data provenance is implied to be from 3M Company's internal testing, as it's a submission for their device. The nature of the tests (resistometer, simulated use, dry heat, side-by-side with BI, color stability) suggests controlled laboratory and simulated clinical environments. It is a nonclinical study, likely prospective for the specific tests performed to demonstrate equivalence or performance.

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

This information is not provided in the document. The tests seem to rely on objective measures (e.g., time to reach endpoint, color change, resistometer readings) rather than subjective expert assessment of an outcome. For 'Endpoint Color Stability', the "endpoint decision must remain unchanged" implies a clear, objective visual criterion rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none). Given the tests are physical/chemical performance evaluations, it's likely they rely on objective measurements and established criteria, reducing the need for adjudication by multiple human observers.

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

No, a MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting diagnostic images or data with and without AI assistance to measure improvement in diagnostic accuracy or efficiency. The 3M™ Attest™ Steam Chemical Integrators are physical/chemical sterilization process indicators, not an AI-powered diagnostic device, so such a study would not be applicable.

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

Yes, the studies reported are standalone performance evaluations of the device itself. The chemical integrators function independently to indicate sterilization parameters; there is no human "in-the-loop" once the integrator is placed in the sterilization cycle. The performance described (e.g., time to "ACCEPT" or "REJECT", endpoint not met in dry heat, correlation with BI) is inherent to the device's chemical and physical properties.

7. Type of Ground Truth Used

The ground truth for these tests is based on established physical and chemical principles and standards for sterilization.

• For SV (Stated Value) testing: It refers to a "stated test organism with stated D and z values," indicating a biological effectiveness standard. The ground truth for what constitutes a successful sterilization cycle (leading to an "ACCEPT" reading) is benchmarked against the known inactivation kinetics of biological indicators (BIs) and the physical parameters (time, temperature, steam) required for sterilization.
• For Health Care Facility Simulated Use Testing: The ground truth is "customer acceptable performance in cleared customer use sterilization cycles" and "failing conditions." This implies real-world or simulated real-world conditions where the outcome of sterilization (successful or failed) is known through other means (e.g., standard monitoring, biological indicators).
• For Dry Heat Testing: The ground truth is the absence of saturated steam, and the expected outcome for the device (not reaching endpoint).
• For Side-by-Side Testing with Biological Indicator: The ground truth is the performance of the biological indicator (BI), which is considered the gold standard for sterilization efficacy. The chemical integrator's performance is compared directly against the BI's inactivation.
• For Endpoint Color Stability: The ground truth is the initial "ACCEPT" or "REJECT" endpoint color, with the expectation that it should not change over time.

8. Sample Size for the Training Set

This question is not applicable as the 3M™ Attest™ Steam Chemical Integrators are not an AI or machine learning device that requires a training set. They are physical/chemical indicators.

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

This question is not applicable for the same reason as above.

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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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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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