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3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE: Use the 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE in conjunction with the 3M™ Attest™ Auto-reader 490, the 3MM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycle:

3MTM AttestTM Auto-reader 490:

The 3MTMAttest™ Auto-reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493, at 60°C for a final fluorescent result at 24 minutes.

3MTM AttestTM Auto-reader 490H:

The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1493 at 60°C for a final fluorescent result at 24 minutes.

3MTM AttestTM Mini Auto-reader 490M:

The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3MTM Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1493, at 60°C for a final luorescent result at 24 minutes.

The 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE is designed to qualify and monitor extended dynamic-air-removal steam sterilization processes at 270°F (132°C) in healthcare facilities.

The 1492PCDE Challenge Pack consists of a clear plastic shell, with a tortuous channel allowing for air removal and sterilant penetration. The channel connects to a cavity containing the monitoring products and all are covered by a foil lid. The 1492PCDE is a single-use device.

Each 1492PCDE Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1492V (brown cap) and a 3M™ Attest™ Steam Chemical Integrator (CI). The CI verifies that the stated values for the three critical parameters of exposure time, temperature, and steam saturation have been achieved. Upon exposure to steam a dark color visible through a window migrates along the indicator strip and offers an ACCEPT or REJECT reading. The 1492V Biological Indicator (BI) is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490, a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The presence of fluorescence within the specified incubation time of the 1492V BI in the 490, 490H or 490M Auto-reader indicates a steam sterilization process failure. A chemical process indicator is present on the brown cap of the 1492V BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink to light brown or darker upon exposure to steam. The process indicator is used by the customer to verify that the challenge pack was exposed to steam.

The provided document does not describe a study involving an AI/software as a medical device (SaMD). Instead, it details a 510(k) premarket notification for a sterilization process indicator system (3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, 3M™ Attest™ Auto-reader 490, 3M™ Attest™ Auto-reader 490H, 3M™ Attest™ Mini Autoreader 490M).

Therefore, many of the requested elements pertaining to AI/SaMD studies (e.g., test sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of device and are not present in the document.

However, I can extract the relevant acceptance criteria and study information for this medical device as described in the document.

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

Device: 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, 3M™ Attest™ Auto-reader 490, 3M™ Attest™ Auto-reader 490H, 3M™ Attest™ Mini Auto-reader 490M. This system is a sterilization process indicator, not an AI or imaging device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size:
  • Resistance testing: "Three lots of 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE, containing three lots of 1492V BIs and three lots of 1243R CIs, were tested side by side..." This refers to three manufacturing lots of the complete challenge pack, each containing BIs and CIs.
  • Peel Force: "Three lots of 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE were tested for peel force..."
• Data Provenance: The document does not specify the country of origin of the data. The tests are described as "nonclinical" and are laboratory/bench tests, not patient data. It is inherently "prospective" in that these are tests conducted to evaluate the performance of newly manufactured devices.

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

• Not Applicable. This is a hardware/chemical/biological indicator device. The "ground truth" for its function relies on physical and biological principles of sterilization effectiveness (e.g., growth or no growth of spores after sterilization, chemical indicator color change) and engineered peel strength, not expert interpretation of complex data like medical images.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3. Testing is objective based on measurable outcomes (e.g., spore growth, resistance time, peel force), 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:

• Not Applicable. This is not an AI-assisted diagnostic or interpretive device. No human readers or AI assistance are involved in its primary function for evaluating sterilization.

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

• Not Applicable. This is a physical device and biological indicator system, not an algorithm. The "auto-readers" interpret fluorescence from the biological indicators, which is an automated process, but it's part of the device's inherent function, not an AI or standalone algorithm as generally understood in the context of SaMD.

7. The Type of Ground Truth Used:

• The ground truth is based on:
  • Biological Indicator (BI) performance: Growth or no growth of Geobacillus stearothermophilus spores after exposure to sterilization cycles, as read by the auto-readers. This is the definitive biological validation of sterilization.
  • Chemical Indicator (CI) performance: Color change (ACCEPT/REJECT) indicating exposure to critical sterilization parameters.
  • Physical Strength (Peel Force): Mechanical measurement of the force required to peel the lid.
  • Comparison to AAMI 16 Towel PCD: A recognized standard challenge device for sterilization.

8. The Sample Size for the Training Set:

• Not Applicable. This is not a machine learning or AI device that requires a "training set" in the context of software development.

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

• Not Applicable. See point 8.

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