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Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3MTM Attest™ Auto-reader 490H or 490 Auto-reader having software version 4.0.0 or greater or 490M Auto-reader as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO® I Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles), STERIS® V-PRO® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, and Flexible cycles) and in STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with AllClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with AllClear™ Technology (Standard, Flex, Express and Duo cycles),

The 3MTM AttestTM Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490H or the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M. The 1295 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a color-coded cap. A chemical process indicator printed with stripes which change from blue toward pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The detection of fluorescence upon incubation of the 1295 BI in one of the designated Attest™ Auto-readers indicates a sterilization failure.

This document describes regulatory approval for a Biological Indicator (a type of sterilization process indicator) and as such does not contain information on an AI/ML device. Therefore, it is impossible to answer the questions as formulated because the provided text is about a hardware device, not software/AI.

However, based on the provided text, here's a breakdown of the acceptance criteria and study that demonstrates the device meets these criteria for the 3M™ Attest™ Rapid Readout Biological Indicator 1295:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and data provenance:
The document does not specify the exact sample sizes (number of biological indicators) used for each test. The study was a nonclinical performance test conducted to demonstrate performance in a newly claimed sterilizer and its cycles. As such, the provenance is likely from laboratory testing rather than human clinical data (e.g., country of origin, retrospective/prospective). While not explicitly stated, such tests are typically conducted in a controlled lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a biological indicator for sterilization processes. Its performance is measured by biological and chemical responses (fluorescence, growth, color change), not by human interpretation or diagnosis requiring expert ground truth.

4. Adjudication method for the test set:
This information is not applicable for the same reason as point 3. The outcomes are objective measurements of biological and chemical changes.

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 information is not applicable as the device is a biological indicator for sterilization processes, not an AI/ML diagnostic tool for human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable as the device is a biological indicator, not an algorithm or AI. Its "performance" is inherently "standalone" in the sense that it reacts biologically/chemically to sterilization conditions, and then the auto-reader interprets that reaction. There isn't a human-in-the-loop interpretation phase in the same way there would be for an AI diagnostic.

7. The type of ground truth used:
The ground truth is based on the biological viability of Geobacillus stearothermophilus spores and the chemical reaction of the indicator ink.

• For Full Cycle and Fractional Cycle Performance: The ground truth is the presence or absence of spore growth, determined by fluorescence and growth response. A "negative" result in a properly sterilized cycle indicates successful killing of spores, which is the desired outcome.
• For Chemical Indicator Color Change: The ground truth is the expected color change of the indicator upon exposure to hydrogen peroxide.

8. The sample size for the training set:
This information is not applicable as the device is a biological indicator and not an AI/ML algorithm that requires a training set. The device itself is designed and validated; it does not "learn" from data.

9. How the ground truth for the training set was established:
This information is not applicable as the device is not an AI/ML algorithm and therefore does not have a "training set" or "ground truth for a training set" in the context of机器学习. Its performance is based on its inherent biological and chemical properties, validated through laboratory testing as detailed in point 7.

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

The following Indications for Use are proposed for the 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V, as well as the vaporized hydrogen peroxide biological indicator, 3M™ Attest™ Rapid Readout Biological Indicator 1295. The only change to the previously cleared indications for the Mini Auto-reader 490M as being able to be used in conjunction with each of the BIs:

Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to monitor gravity displacement steam sterilization cycles of 3 minutes at 270°F (132°C), 10 minutes at 270°F (132°C), 3 minutes at 275°F (135°C) and 10 minutes at 275°F (135°C). An optional visual pH color change result is observed in 24 hours.

Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with the 3MTM Attest™ 490/490H Auto-reader or 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal (prevacuum) steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°C). An optional visual pH color change result is observed in 48 hours.

Use 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ 490/490H Autoreader or 3M™ Attest™ Mini Auto-reader 490M as a standard method of routine monitoring of vaporized hydrogen peroxide sterilization processes in the following systems: AMSCO® V-PRO™ 1 Low Temperature Sterilization System (Lumen cycle), AMSCO® V-PRO™ 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles), AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, and Flexible cycles), AMSCO® VPRO™ 60 Low Temperature Sterilization System (Lumen and Flexible cycles) and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex, Express and Duo cycles) systems, STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles) and STERRAD® 100NX with ALLClear™ Technology (Standard, Flex, Express and Duo cycles). An optional visual pH color change result is observed in 7 days.

The 3M™ Attest™ Mini Auto-reader 490M is a compact, 4-well incubator for processing the steam biological indicators 3M™ Attest™ Super Rapid Readout Biological Indicators 1491 and 1492V, as well as the vaporized hydrogen peroxide biological indicator, 3M™ Attest™ Rapid Readout Biological Indicator 1295. These biological indicators (BIs) are used to monitor sterilization processing equipment. After a sterilization cycle is complete, the Bls are removed from the sterilizer, cooled as needed, activated, and placed into any available well in the Mini Auto-reader 490M. Incubation starts automatically, UV fluorescence, measured during each interval, is analyzed by measuring fluorescent by-product of enzyme that occurs naturally during biological growth of the spore. The maximum time-to-result is 24 minutes at 600C. An LED array on the front panel will display the time remaining for each BI, the result (positive or negative), and any error codes that occur. The device includes USB connectivity for in-field firmware updates, downloading data, and communicating to third party instrument tracking systems.

The 3MM Attest™ Mimi Auto-reader 490M is indicated to work as a system with the 1491, 1492V, and is not compatible with other BIs.

Here's a breakdown of the acceptance criteria and study information for the 3M™ Attest™ Mini Auto-reader 490M, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The core acceptance criteria for the 3M™ Attest™ Mini Auto-reader 490M are based on its ability to accurately incubate and read specific 3M™ Attest™ Biological Indicators (BIs) to provide fluorescent results within a specified timeframe. The device's performance is compared against a predicate device (3M™ Attest™ 490/490H Auto-reader) and established safety and electromagnetic compatibility standards.

Table of Acceptance Criteria and Reported Device Performance:

Study Details for Device Performance

The provided document doesn't detail a single, comprehensive "study" with specific sample sizes for test and training sets in a typical AI/software context. Instead, it describes nonclinical comparison testing to demonstrate substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The testing involved "testing the 1491, 1492V, and 1295 BIs in both auto-readers." This implies multiple BIs of each type were tested. The specific number of BIs and repetitions is not provided.
• Data Provenance: Not specified. The manufacturer (3M Company) is based in St. Paul, Minnesota, USA, suggesting the testing likely occurred in the USA or a controlled laboratory environment.
• Retrospective or Prospective: The nonclinical comparison testing described appears to be prospective testing, specifically designed to evaluate the new device against the predicate under controlled laboratory conditions.

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 this type of device and study. The "ground truth" for a biological indicator reader is based on the known biological response of the biological indicator to sterilization conditions. Experts would be involved in designing the test protocols for sterilization cycles and interpreting the results, but not in establishing a subjective "ground truth" like in image interpretation tasks. Sterilization efficacy is objectively measured.

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

Not applicable. Adjudication methods are typically used when subjective interpretations (like medical image diagnosis) require a consensus among multiple human readers. For this device, the "reading" is an automated fluorescent measurement.

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 device that involves human readers. It is an automated reader for biological indicators.

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

Yes, the described nonclinical comparison is a standalone (algorithm only) performance evaluation. The device (the auto-reader) automatically interprets the fluorescent signal from the biological indicators without human intervention in the reading process itself to determine a pass/fail result. Human users only activate the BI and place it into the reader, then read the final result displayed by the device.

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

The ground truth for the biological indicator testing is established by:

• Known Biological Response: The expected growth or no-growth of the Geobacillus stearothermophilus spores within the biological indicators under specific sterilization conditions.
• Controlled Sterilization Cycles: The tests involved "positive control conditions," "lethal sterilizer conditions (kill cycle)," and "sub-lethal sterilizer conditions (survive cycle)." These cycles are precisely controlled to known sterilization outcomes (i.e., complete kill or partial inactivation/survival leading to growth). The "ground truth" is therefore derived from the physical and biological conditions applied, not from human interpretation.

8. The sample size for the training set

Not applicable. This device is an auto-reader that performs fluorescent detection and signal processing based on a biological mechanism, not a machine learning or AI model that requires a "training set" in the conventional sense. The "training" for such a system would involve engineering and calibration against known fluorescent standards and biological responses.

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

Not applicable, as there isn't a "training set" in the conventional machine learning sense. The device's "knowledge" is built into its hardware and firmware, based on established scientific principles of bioluminescence/fluorescence and the known growth characteristics of the biological indicator organisms. This involves:

• Biochemical principles: Understanding the enzyme activity and fluorescent byproduct generation.
• Sterilization science: Knowledge of how sterilization processes affect microorganisms.
• Calibration: Using known standards (e.g., reference dye solutions) to calibrate the fluorescent detection system.

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