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Use the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V in conjunction with the 3M™ Attest™ Auto-reader 490 or 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).

The 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V and the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V are specifically designed to qualify or monitor dynamic-air-removal steam sterilization cycles of 4 minutes at 270°F (132°C) and 3 minutes at 275°F (135°C).

The 1496V and 41482V Challenge Packs consist of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. The Challenge Packs have the same design as the predicate device. Each 1496V Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V while the 41482V Challenge Pack contains a 1492V BI and a 3M™ SteriGage™ Steam Chemical Integrator (Type 5 Integrating Indicators as categorized by ISO 11140-1:2014). The 1492V BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater). A fluorescence change indicates a steam sterilization process failure. 3M™ Attest™ 1492V BI controls are provided with the Challenge Packs. Each Challenge Pack has a process indicator on the outside of the device that changes from vellow to brown or darker when exposed to steam.

This submission is addressing a software change to the 3M™ Attest™ Auto-reader 490 to reduce the final fluorescent readout for the 1492V BI from 1 hour to 24 minutes, and to change the incubation temperature from 56°C to 60°C making the 490 Auto-reader identical to the 490H Auto-reader (software version 4.0.0 or greater). The 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V, the 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, and the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V are the same design as the previously cleared devices of the same model numbers. The ComplyTM SteriGage™ Steam Chemical Integrators contained within the 41482V challenge pack are the same as those in the predicate device. The device has the same materials and fundamental scientific technology.

The provided text describes the 3M™ Attest™ Super Rapid Readout Steam Challenge Pack 1496V, 3M™ Attest™ Super Rapid 5 Steam-Plus Challenge Pack 41482V, and the 3M™ Attest™ Auto-reader 490 and 490H, particularly focusing on a software change to the Auto-reader that reduces the readout time and changes the incubation temperature. The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes (number of challenge packs or biological indicators) used for the resistance tests. It refers to general "testing" and "evaluations." The data provenance is not specified, but given it's a 3M product and an FDA submission, it's highly likely the testing was conducted in a controlled laboratory environment (likely in the US or collaborating with US-based labs) and is prospective in nature, designed specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of device (biological indicator and auto-reader for sterilization) does not involve expert interpretation in the same way as medical imaging or diagnostic tests. The ground truth for biological indicators is objective: bacterial growth (or lack thereof) indicates sterilization failure (or success). The "ground truth" for the tests mentioned (resistance, temperature maintenance, safety, EMC) is based on established scientific and engineering standards. Therefore, no human "experts" are engaged in adjudicating the results in the traditional sense; rather, the tests are performed according to validated protocols and assessed against predefined criteria.

4. Adjudication method for the test set

Not applicable. The tests described are objective performance measurements against established standards, not subjective interpretations requiring adjudication by experts.

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 device is a biological indicator and an auto-reader for sterilization processes. It's not an AI-powered diagnostic tool requiring human interpretation or MRMC studies. The device provides a direct, objective result (fluorescent positive/negative) indicating sterilization effectiveness.

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

The device itself is essentially a "standalone" system in terms of its core function: the Auto-reader reads the biological indicator and provides a result. There is no human interpretation of an algorithm output that then influences a decision. The fluorescent result is the output, signaling success or failure. The document focuses on the performance of the biological indicator and the auto-reader together, which is its intended standalone function.

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

The ground truth for the device's primary function (sterilization monitoring) relies on the principle of microbial death.

• Resistance of Challenge Pack: Ground truth is established by comparing its resistance to a recognized standard - the AAMI 16 Towel Process Challenge Device (PCD) described in ANSI/AAMI ST79:2017. This standard itself is based on extensive research and consensus within the sterilization community regarding a robust challenge to sterilization processes.
• Biological Indicator Performance: The biological indicator (BI) itself contains Geobacillus stearothermophilus spores. The "ground truth" for its function is the viability of these spores after exposure to sterilization conditions. If spores survive, the sterilization process failed, indicated by fluorescence in the Auto-reader. If they are all killed, the process was successful, and no fluorescence is detected.
• Auto-reader Temperature Maintenance: The ground truth is the actual measured temperature by calibrated sensors, compared against the specified range ($60 \pm 2$ ℃).
• Electrical Safety and EMC: Ground truth is compliance with specified international and national standards (IEC 61010-1, IEC 61010-2-010, USA Title 47 CFR, IEC 61326-1:2012).

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning algorithm that requires a "training set." Its functionality is based on biological response (spore viability) and physical measurements (fluorescence, temperature), not pattern recognition learned from data.

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

Not applicable, as there is no training set for this type of device.

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Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V in conjunction with both the 3M™ Attest™ Auto-reader 490 or the Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal steam sterilization cycles of:

• · 3 minutes at 270°F (132°C)
• · 4 minutes at 270°F (132°C)
• · 3 minutes at 275°F (135°C)

The 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 or the 3M™ Attest™ Auto-reader 490H (software version 4.0.0 or greater) to qualify or routinely challenge dynamic-air-removal steam sterilization cycles at 132°C and 135°C.

The 1492V BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1492V BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of fluorescence upon incubation of the 1492V BI in the 490 Auto-reader or the 490H Auto-reader (software version 4.0.0 or greater) indicates a sterilization failure.

The provided text describes the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V, 3M™ Attest™ Auto-reader 490, and 3M™ Attest™ Auto-reader 490H. This is a Class II medical device used for monitoring steam sterilization cycles.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

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 a specific "test set" sample size in terms of number of biological indicators or cycles tested for all the non-clinical tests. However, it indicates that testing was conducted following FDA guidance and relevant ISO/ANSI standards, which typically specify minimum sample sizes for such evaluations.

Regarding data provenance: The studies are non-clinical bench and laboratory tests, meaning the data was generated in a controlled testing environment, not from patient populations. There is no information about country of origin of the data provided, but the submission is to the U.S. FDA by 3M Health Care, St. Paul, MN, USA. The data is prospective in the sense that it was generated specifically for this submission to demonstrate compliance with performance and safety standards.

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

This information is not applicable as the device is a biological indicator system, not an AI or diagnostic device that relies on expert human interpretation for establishing ground truth for test sets. The "ground truth" for these tests is based on objective, quantifiable biological and physical parameters (e.g., spore kill, fluorescence detection, temperature stability) governed by established international standards like ISO 11138-1 and ISO 11138-3.

4. Adjudication Method for the Test Set:

This is not applicable for the reasons stated above. The tests performed are objective and do not involve human interpretation 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 an automated biological indicator system, not a device intended for interpretation by human readers, nor does it incorporate AI for diagnostic or interpretive purposes in the context of human "reading." Therefore, no MRMC study was performed or is relevant.

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

The device (3M™ Attest™ Auto-reader 490/490H) is inherently a standalone automated system for reading the biological indicators. The "algorithm" (software version 4.0.0 or greater) in the auto-reader automatically detects fluorescence and provides a result (positive/negative) at 24 minutes without human intervention in the reading process itself. The non-clinical tests described demonstrate the performance of this system (biological indicator + auto-reader) in a standalone capacity.

7. The Type of Ground Truth Used:

The ground truth used for proving the device performance relies on:

• Biological Viability: The presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization cycles, as determined by growth and metabolic activity leading to fluorescence. This is the fundamental "ground truth" for biological indicators.
• Physical Measurements: Precisely controlled temperature and time exposures during resistance testing to establish D-values, survival times, and kill times according to ISO standards.
• Established Standards: Adherence to defined parameters and methodologies dictated by ISO 11138 series, USP chapters, and FDA guidance for biological indicators.

8. The Sample Size for the Training Set:

This information is not explicitly provided in the document. However, "training set" is typically a term used for machine learning or AI models. Given that this device is a biological indicator system and auto-reader, its underlying principles are based on biological and chemical reactions and established parameters, not on machine learning requiring a training set in the conventional sense. The "training" of the system would be its design and calibration based on known biological and chemical properties of Geobacillus stearothermophilus and its interaction with the growth medium and the auto-reader's detection mechanism.

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

As mentioned above, the concept of a "training set" in the context of AI/ML is not directly applicable here. The "ground truth" for the development and validation of the biological indicator and auto-reader system would be established through extensive foundational research in microbiology, sterilization science, and optical detection technology. This would involve:

• Microbiological Standards: Using certified strains of Geobacillus stearothermophilus (traceable to ATCC™ 7953) with known resistance characteristics.
• Controlled Sterilization Cycles: Running precisely controlled steam sterilization cycles with varying conditions to determine spore survival and kill rates.
• Fluorescence Detection Principles: Understanding the biochemical reactions that lead to fluorescence in the presence of viable spores and designing the auto-reader's optics to reliably detect this signal.
• Calibration: Calibrating the auto-reader's detection threshold and timing based on these established biological and chemical principles to accurately differentiate between sterile and non-sterile conditions.

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Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ Attest™ Auto-reader 490H 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, Non Lumen, and Flexible cycles), AMSCO® V-PRO™ 60 Low Temperature Sterilization System (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 3M™ Attest™ 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 3M™ Attest™ Auto-reader 490H. The 1295 BI is a single-use device composed of a polycarbonate 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 the 490H Auto-reader indicates a sterilization failure.

The document describes a 510(k) premarket notification for the 3M™ Attest™ Rapid Readout Biological Indicator 1295. This submission aims to expand the indications for use of an existing device to include additional sterilizers.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that testing was "in accordance with the FDA Guidance for Industry and FDA Staff: Biological Indicator (BI) Premarket Notification [510(k)] Submissions, and ANSV/AAMI/ISO 11138-1:2006/(R) 2010 Sterilization of health care products- Biological indicators- Part 1: General requirements." These standards outline specific performance requirements for biological indicators, which would serve as the detailed acceptance criteria, although they are not explicitly listed in this summary. For example, ISO 11138-1 specifies D-value requirements (resistance) and population count. The table in the document implicitly refers to meeting these established standards by indicating "Pass."

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

• Sample Size: The document does not explicitly state the numerical sample size used for each "Performance Test." It refers to "testing of the 3M™ Attest™ Rapid Readout Biological Indicator 1295" in conjunction with various sterilizers. The specific number of BIs tested in each cycle, or in total, is not provided in this summary.
• Data Provenance: The document does not specify the country of origin of the data. It is a premarket notification to the US FDA, so the testing was likely conducted in the US or under US regulatory guidelines. The data is nonclinical, focusing on device performance under controlled laboratory conditions, not on patient outcomes or clinical usage. It is prospective in the sense that the tests were specifically conducted to demonstrate the device's performance for this submission.

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

• This information is not applicable to this type of device and study. The "ground truth" for a biological indicator is established by controlled laboratory sterilization conditions (e.g., exposure to known sterilant concentrations for specific times) and subsequent microbiological culturing to determine spore viability, not by expert interpretation of images or clinical data.

4. Adjudication Method for the Test Set:

• Not applicable in the context of biological indicator performance testing. The "ground truth" (sterilization success/failure, population count, D-value) is determined by objective laboratory methods (e.g., culture growth, spectrophotometry).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This type of study typically applies to diagnostic imaging devices where human readers interpret medical images with and without AI assistance. This submission describes a biological indicator, which is a device for monitoring sterilization processes, not for human interpretation.

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

• Yes, a standalone performance assessment was effectively done. The 3M™ Attest™ Rapid Readout Biological Indicator 1295 is a device that interacts with the 3M™ Attest™ Auto-reader 490H to produce a "fluorescent readout of 24 minutes." The performance tests (Full Cycle, Half Cycle, CI Color Change, Population Characteristics) evaluated the integrity and function of the BI system (BI + Auto-reader) without human intervention in the interpretation of the biological outcome beyond observing the auto-reader's output or visual color change. The phrase "detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure" describes the automated, standalone output of the device combination.

7. The Type of Ground Truth Used:

• The ground truth for this device is based on microbiological viability (survival or kill of Geobacillus stearothermophilus spores) under controlled sterilization conditions. This involves:
  • Known exposure to sterilant: Exposing the biological indicators to specific cycles in various sterilizers (e.g., Full Cycle and Half Cycle conditions).
  • Microbiological culture: Incubating the BIs after exposure to determine if the spores are alive (growth indicated by fluorescence) or killed (no growth).
  • Population counts: Determining the initial number of viable spores on the carrier.
  • Resistance characteristics (D-value, Survival/Kill Window): Quantifying the resistance of the spores to the sterilant under controlled conditions.

8. The Sample Size for the Training Set:

• The document does not report a training set sample size. This is because the device described is a biological indicator, not an AI/ML algorithm that requires a training set. The device operates based on established microbiological principles and chemical reactions.

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

• As there is no training set for an AI/ML algorithm, this question is not applicable. The underlying principles of how biologic indicators should perform (e.g., spore resistance, growth media reaction, fluorescence detection) are based on well-established microbiology and analytical chemistry, not on machine learning from a training set.

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Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ Auto-reader 490 or 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater to monitor the cycles below.

The 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 is a self-contained biological indicator (BI) specifically designed to be used with the 3MTM Attest™ Auto-reader 490 or the 3MTM Attest™ Auto-reader 490H (software version 4.0.0 or greater) to routinely monitor gravity displacement steam sterilization cycles at 132°C and 135°C.

The 1491 BI is a single-use device composed of a polycarbonate sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1491 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The detection of fluorescence upon incubation of a processed 1491 BI in the 490 Auto-reader or the 490H Auto-reader (software version 4.0.0 or greater) indicates a sterilization failure.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 and 3M™ Attest™ Auto-reader 490/490H.

1. Table of Acceptance Criteria and Reported Device Performance

This product is a biological indicator system, not a device that relies on traditional performance metrics like sensitivity/specificity for disease detection. Instead, its performance is evaluated against established standards for sterilization monitoring.

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

The document does not explicitly state specific sample sizes for each test within the "Summary of Nonclinical Testing" section. Instead, for each test, it simply reports "Passed" for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1491 in conjunction with the 3M™ Attest™ Auto-reader 490 with a final fluorescent readout of 24 minutes and an incubation temperature of 60°C.

The data provenance is from nonclinical testing conducted by 3M Company, following FDA guidance and international standards (ISO, USP, ANSI/AAMI). There is no information provided about the country of origin of the data beyond "3M Company" which is based in St. Paul, Minnesota, USA. The study design is not specifically labeled "retrospective" or "prospective," but given it's for a 510(k) submission, it's a prospective collection of new test data to demonstrate equivalence.

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

This type of device (biological indicator for sterilization) does not involve human expert interpretation for establishing ground truth in the same way a diagnostic imaging AI might. The ground truth for biological indicators is established through controlled laboratory methods and adherence to validated scientific standards (e.g., specific spore counts, resistance characteristics, and survival/kill times under defined sterilization parameters). The "ground truth" is a measurable biological response, not an expert assessment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is based on measurable biological and physical parameters according to standardized test methods, not expert adjudication of subjective findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a biological indicator system for monitoring sterilization, not a diagnostic imaging or interpretive device that would involve human readers.

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

Yes, the testing described is primarily standalone performance of the biological indicator and auto-reader system. The "Nonclinical Comparison to the Predicate Device" and "Summary of Nonclinical Testing" sections detail the performance of the device itself against established criteria and standards. The system automatically reads and interprets the fluorescent signal from the biological indicator. While a human initiates the process and reads the final result (e.g., "Passed"), the core performance metrics are derived from the automated system's capabilities.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Biological Activity and Resistance Characteristics: Specifically, the known and measurable resistance of Geobacillus stearothermophilus spores (traceable to ATCC™ 7953) to defined steam sterilization cycles. This includes metrics like D-value, survival time, and kill time.
• Physical and Chemical Standards: Performance metrics related to incubation temperature, spore population counts, and the absence of inhibitory components.
• Regulatory and Industry Standards: Compliance with ISO 11138-1:2017, ISO 11138-3:2017, ANSI/AAMI/ISO 18472:2006, United States Pharmacopeia Chapters and , and FDA Guidance for Biological Indicators.
• Electrical and Electromagnetic Compatibility Standards: Compliance with IEC 61010-1, IEC 61010-2-010, FCC Part 15, and IEC 61326-1.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI algorithm development. This device is a biological indicator system, not an AI or machine learning model that requires a training phase. The software changes mentioned for the Auto-reader (reducing readout time, changing incubation temp) are likely based on engineering design and validation rather than a data-driven training process.

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

As there is no described "training set" for an AI/ML algorithm development, this question is not applicable. The device's functionality is based on biological and electro-mechanical principles validated against established scientific and regulatory standards.

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