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Use the 3M TM Attest TM Rapid Readout Biological Indicator 1295 in conjunction with the 3M TM Attest TM 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: STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Non Lumen, Flexible, and Fast Non Lumen cvcles) V-PRO® &2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1) SteroScope® Sterilization System

Use the 3M IM Attest TM Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E for pack control monitoring of the following hydrogen peroxide sterilization sterilizers and cycles: STERRAD 100S® Sterilization System STERRAD NX® Sterilization System (Standard and Advanced cycles) STERRAD 100NX® Sterilization System (Standard, Flex, Express and Duo cycles) STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles) STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo cycles) V-PRO® 1 Low Temperature Sterilization System (Lumen cycle) V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles) V-PRO® maXLow Temperature Sterilization System (Lumen, and Flexible cycles) V-PRO® 60 Low Temperature Sterilization System (Lumen and Flexible cycles) V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles) V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1) SteroScope® Sterilization System

3M™ Attest™ Rapid Readout Biological Indicator 1295: 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 3MTM Attest™ Auto-reader 490H or the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3MTM 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.

3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E: The 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E is a chemical indicator consisting of a non-cellulose based coated indicator strip sensitive to vaporized hydrogen peroxide, contained in a film laminate. There has been no change to the product construction compared to the predicate submission, K212022. The 3M™ Attest™ CI 1348/1348E verifies that the stated values for the three critical parameters of exposure time, temperature, and concentration of vaporized hydrogen peroxide have been achieved within a package or containment device (i.e. wrapped trays, rigid containers, sterilization pouches, and other types of packs) and/or at a specific location within the load or empty chamber. Upon exposure to vaporized hydrogen peroxide, the color of the coated indicator strip progressively changes from blue toward pink along the strip. The progression of the blue to pink color change along the strip is visible through a window with marked "REJECT" and "ACCEPT" zones. The extent of the progression depends on exposure time, temperature, and concentration of vaporized hydrogen peroxide.

The provided text describes premarket notification for two devices: 3M™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E. The key new information in this submission is the addition of the "SteroScope® Sterilization System" to the indications for use for both devices. The acceptance criteria and the study performance for this new indication are detailed.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Device: 3M™ Attest™ Rapid Readout Biological Indicator 1295 (for SteroScope® Sterilization System)

Device: 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E (for SteroScope® Sterilization System)

Study Details

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

The document does not explicitly state the specific numerical sample sizes for the test sets (e.g., number of BIs or CIs tested in each condition). Instead, it uses qualitative statements like "All biological indicators" and quantitative statements related to percentages of the population of indicators.

• Data Provenance: The testing was "performed in a health care facility" (for the Chemical Indicator) and implicitly in a laboratory/testing environment for the Biological Indicator. The data is prospective, as it was generated specifically to demonstrate performance for the expanded indications. The country of origin is not specified, but given the FDA submission, it's likely U.S.-based or compliant with U.S. regulatory standards.

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

The document does not mention the use of experts or their qualifications for establishing ground truth. The ground truth for these types of devices (Biological and Chemical Indicators) is typically established through precisely controlled sterilization cycles using calibrated equipment and defined parameters (e.g., successful sterilization leading to no growth for BIs, or specific chemical changes for CIs). The "Visual assessment" mentioned for the CI implies human observation, but it doesn't specify if these were expert readers or how many.

4. Adjudication method for the test set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1). For the chemical indicator, it mentions "Visual assessment," but no details on multiple readers or adjudication are provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is more common for diagnostic imaging AI devices, where human perception and interpretation are key variables. For sterilization indicators, the evaluation focuses on the device's intrinsic performance against defined physical/chemical/biological criteria rather than how human readers' diagnostic accuracy is improved with AI assistance.

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

This question is not directly applicable in the context of these specific devices. The Biological Indicator's readout is automated by an "Auto-reader," which itself performs the "algorithm" (fluorescence detection). The Chemical Indicator's performance is determined by a visual color change. There isn't an "AI algorithm" in the typical sense (e.g., for image analysis) being evaluated here. The "standalone" performance is essentially the performance of the indicators themselves, which is what the non-clinical tests evaluate.

7. The type of ground truth used

• For the 3M™ Attest™ Rapid Readout Biological Indicator 1295:
  • Biological Ground Truth: Absence or presence of fluorescent and/or microbial growth, indicating kill or survival of Geobacillus stearothermophilus spores after exposure to sterilization cycles. This is established by standard microbiological methods and incubation in the auto-reader.
• For the 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E:
  • Physical/Chemical Ground Truth: The successful achievement of specified exposure time, temperature, and vaporized hydrogen peroxide concentration (ACCEPT result) or failure to achieve these conditions (REJECT result). This is confirmed by the color change progression of the indicator and validated against the known conditions of the sterilization cycles (i.e., "complete/full cycle" vs. "fractional/incomplete cycle"). The "Visual assessment" is against this physical/chemical ground truth.

8. The sample size for the training set

The document does not provide information on a "training set" or its sample size. These devices are physical/chemical/biological indicators, not AI/machine learning models that typically require training data. The testing described is verification and validation, not model training.

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

As there is no mention of a "training set" or AI/ML model for these devices, this question is not applicable to the provided information.

Ask a specific question about this device

Use the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M™ 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:
STERRAD 100S® Sterilization System
STERRAD NX® Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)
STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)
STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)
V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)
V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)
V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)
V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)
V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)
V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)
STERIZONE® VP4 Sterilizer (Cycle 1)

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 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.

The FDA 510(k) summary for the 3M™ Attest™ Rapid Readout Biological Indicator 1295 (K211705) describes the acceptance criteria and the study that proves the device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The above table specifically refers to the nonclinical testing performed to demonstrate performance in the newly claimed sterilizer and cycles (STERIZONE® VP4 Sterilizer, Cycle 1), which is the primary reason for this new 510(k) submission as the device itself is identical to a previously cleared predicate.

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

The document does not explicitly state the specific numerical sample size for the test set used in the full, fractional, and chemical indicator performance tests. It states that "nonclinical testing was performed."

• Sample Size: Not explicitly quantified in the provided text.
• Data Provenance: The testing was nonclinical, performed in a laboratory setting to evaluate the device's performance with the newly included STERIZONE® VP4 Sterilizer (Cycle 1). The country of origin is not specified but implicitly linked to the sponsor, 3M Health Care, based in St. Paul, MN, USA. The study is prospective in nature as it is a validation of the device's performance under specific conditions to support regulatory clearance.

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

This type of information is generally not applicable to biological indicator performance studies. The ground truth for such studies is established through objective, predefined physical and biological measurements rather than expert human interpretation.

Therefore:

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1 used in clinical imaging studies) is not applicable here because the "readout" of a biological indicator (fluorescent and visual response) is a direct, objective measurement rather than a subjective interpretation requiring consensus among multiple readers.

Therefore:

• Adjudication Method: Not applicable.

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 is relevant for medical devices involving human interpretation (e.g., radiologists reading images) to assess the impact of AI assistance on human performance. Biological indicators like the 3M™ Attest™ are designed for objective, automated readout and do not involve human diagnostic interpretation.

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

Yes, the studies described are essentially "standalone" in nature, focusing on the biological indicator's performance based on its inherent characteristics and interaction with the auto-reader and sterilizer. The device functions independently in terms of its biological response to sterilization conditions, and the auto-reader provides an objective "readout" (fluorescent or visual response) without human intervention in the interpretation of the core sterilization effectiveness.

7. The Type of Ground Truth Used

The ground truth for biological indicator performance studies is based on:

• Biological Activity: The viability of Geobacillus stearothermophilus spores.
• Physical Parameters: The exposure of the BI to specific sterilant concentrations (vaporized hydrogen peroxide at 10 mg/L) and time.
• Negative Fluorescent/Visual Response: The absence of growth (negative fluorescent and negative visual response) for sterilized indicators and presence of growth for unsterile/fractionally treated indicators.
• Material Science: The color change of the chemical indicator based on chemical reaction with hydrogen peroxide.

Essentially, it relies on objective biological and chemical principles, rather than expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/machine learning algorithm. For biological indicators, performance is established through empirical testing against predefined standards (e.g., FDA Guidance, ANSI/AAMI/ISO 11138-1:2017) rather than training models. The document refers to "nonclinical testing" to demonstrate performance.

Therefore:

• Sample Size for Training Set: Not applicable.

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

As there is no "training set" in the context of an AI/ML algorithm:

• How Ground Truth for Training Set Was Established: Not applicable. Instead, the performance of the biological indicator (including its stated D-value and Survival/Kill Window) is established through rigorous testing methods defined by recognized standards for biological indicators.

Ask a specific question about this device

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:

STERRAD 100S® Sterilization System

STERRAD NX® Sterilization System (Standard and Advanced cycles)

STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)

STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)

STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)

V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)

V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)

V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles)

V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)

V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)

V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast 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 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.

The provided text describes the 3M™ Attest™ Rapid Readout Biological Indicator 1295 and its performance in a non-clinical study to demonstrate its effectiveness in additional sterilization cycles.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and the Reported Device Performance:

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

• Sample Size: The document does not explicitly state the exact sample size (number of biological indicators) used for each test. However, it indicates tests were conducted in "each of the full cycles" and "fractional cycles" within the V-PRO® s2 system, implying multiple indicators were used per cycle type.
• Data Provenance: The study was a non-clinical testing performed by the device sponsor (3M Health Care) to support a premarket notification (510(k)). The data provenance is from internal testing conducted by the manufacturer. The country of origin of the data is not specified, but the sponsor is located in St. Paul, Minnesota, USA. The study is a prospective test designed to evaluate the device's performance under specified conditions.

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. The ground truth (i.e., whether sterilization was successful or not) is determined by the biological indicator's response (negative fluorescent and negative growth response for sterility) and the chemical indicator's color change, not by expert interpretation of complex data.

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

This information is not applicable. The outcome of the biological indicator (fluorescence and growth response) and the chemical indicator (color change) are objective readings, not subject to subjective adjudication by multiple readers.

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. The device is a biological indicator, not an AI software intended for interpretation by human readers. It functions as a standalone indicator to confirm sterilization.

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

Yes, the study described is a standalone performance evaluation of the biological indicator. Its function is to independently indicate sterilization success or failure based on its biological and chemical responses, which are then read by a compatible auto-reader. The auto-reader (3M™ Attest™ Auto-reader 490H, 490 with software version 4.0.0+, or 490M) performs the "reading" of the biological indicator without human interpretation of raw data.

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

The ground truth is derived from the biological response of Geobacillus stearothermophilus spores on the indicator and the chemical reaction of the indicator.

• For the full and fractional cycle performance, the ground truth for successful sterilization is a "negative fluorescent and negative growth response" from the biological indicator, meaning the sterilization process successfully killed the spores.
• For the chemical indicator, the ground truth for successful exposure to the sterilant is a "color change from blue toward pink."

This is based on the principle that if the spores are killed and the chemical indicator changes color, the sterilization cycle has been effective.

8. The sample size for the training set:

This information is not applicable as this is a biological indicator, not an AI/machine learning device that requires a training set. The device's function is mechanistic based on biological and chemical reactions, not learned from data.

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

This information is not applicable for the same reason as point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX® (Standard and Advanced cycles) and STERRAD® 100NX® (Standard, Flex, Express, and Duo cycles) systems.

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 provided text describes the regulatory filing (510(k) submission K171003) for the 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Auto-reader 490H. This document details the non-clinical performance evaluation of a device designed to monitor sterilization processes, not an AI/ML medical device for diagnosis or prognosis involving human expert review of medical images.

Therefore, many of the requested points, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "training set details," are not applicable to this specific device and the provided documentation. The study described is a laboratory performance test of a biological indicator and an auto-reader, not a study evaluating human reader performance with or without AI assistance on medical images.

However, I can extract the relevant information from the document to answer the applicable parts of your request:

Device and Study Overview

The device under review is the 3M™ Attest™ Rapid Readout Biological Indicator 1295, used in conjunction with the 3M™ Attest™ Auto-reader 490H. This submission addresses a software change to the Auto-reader to reduce the final fluorescent readout time from 4 hours to 24 minutes. The biological indicator itself (1295 BI) has the same design, materials, and fundamental scientific technology as the previously cleared device.

The "study" in this context refers to non-clinical performance testing conducted to demonstrate that the device, with the reduced readout time, still functions effectively as a biological indicator for monitoring vaporized hydrogen peroxide sterilization processes.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Passed" results for each test. The actual quantitative acceptance thresholds are not explicitly listed in this summary, but the results confirm they were met.

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

• Sample Size for Test Set: The document does not specify the exact number of biological indicators tested for each performance criterion (e.g., how many BIs were used to determine survival time or kill time, or for the reduced incubation time study). It only states "No clinical data was included in this premarket application submission," indicating the tests were non-clinical.
• Data Provenance: The tests would have been conducted in a laboratory setting by 3M Company. The document does not specify the country of origin of the data, but 3M's contact address is St. Paul, Minnesota, USA. The studies are prospective in the sense that they were conducted specifically for this regulatory submission to demonstrate the performance with the new readout time.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This is a non-clinical, in-vitro performance study of a biological indicator and auto-reader. Ground truth is established by the known conditions of the sterilization cycles (e.g., exposure time to sterilant) and the inherent biological response of the Geobacillus stearothermophilus spores. The "truth" is the presence or absence of viable spores after treatment, which is determined by the biological indicator's function, not by human expert interpretation of an outcome.

4. Adjudication Method for the Test Set

• Not Applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The device's readout (fluorescence) is an objective, automated measurement.

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

• No. This is a non-clinical performance study of a device, not a study evaluating human reader performance (with or without AI assistance).

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

• Yes, in essence. The testing described is a standalone performance evaluation of the integrated system (biological indicator + auto-reader algorithm) without human intervention in the interpretation of the results. The 490H Auto-reader automatically interprets the biological indicator and provides a fluorescent readout. The "algorithm" here is the system's ability to detect fluorescence within a specific incubation time.

7. The Type of Ground Truth Used

• Biological/Chemical Performance & Controlled Environmental Conditions: The ground truth for the "Passed" results is based on established scientific principles for biological indicators:
  • Viable spores (positive control): Known viability and growth in ideal conditions.
  • Survival Time: Exposure to a specific, short duration of sterilant where spores are expected to survive.
  • Kill Time: Exposure to a specific, longer duration of sterilant where all spores are expected to be killed.
  • Reduced Incubation Time Alignment: Comparison to the conventional, well-established 7-day incubation method, serving as a gold standard for biological indicator performance. The fluorescence indicates the presence (or absence) of enzyme activity from viable spores.

8. The Sample Size for the Training Set

• Not Applicable. This device does not use machine learning or AI models that require "training sets" in the conventional sense. The "training" of the device is its design and manufacturing to function according to biophysical principles, not an iterative data-driven process.

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

• Not Applicable. (See point 8). The device's function is based on the biological activity of bacterial spores and their response to sterilization, which is a well-understood and established scientific principle in microbiology and sterilization.

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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 Amsco® V-PRO® maX Low Temperature Sterilization System (Lumen, and Flexible cycles), and in STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

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 to pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap. The 1295 BI utilizes the same fundamental technology that exists in current 3M™ Attest™ Rapid Readout and Super Rapid Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.

This document is a 510(k) Premarket Notification for the 3M™ Attest™ Rapid Readout Biological Indicator 1295. Its purpose is to demonstrate substantial equivalence to a legally marketed predicate device. Therefore, the information provided focuses on the device's technical specifications and performance when used in specific sterilization systems, rather than a clinical study of diagnostic accuracy typically associated with AI/ML-driven medical devices.

Despite the fact the question doesn't align with the content, I will extract relevant information that resembles the structure requested.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated in a quantitative table format suitable for diagnostic performance metrics (e.g., sensitivity, specificity). Instead, they are implied through "Pass/Fail" results of various verification tests. The "performance" is the device's ability to demonstrate effective sterilization or sterilization failure.

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

The document does not explicitly state the sample sizes (number of biological indicators or sterilization cycles) used for each individual test. The term "test set" is not directly applicable in the context of this device as it refers to a validation process for an AI/ML model. Instead, these are non-clinical verification tests of a biological indicator.
The data provenance is not specified by country of origin, but the testing was conducted to prove the effectiveness of the BI in the Amsco® V-PRO® maX Low Temperature Sterilization System. The studies are non-clinical and likely performed in a laboratory setting. These are prospective tests of the device's performance, not retrospective analysis of existing data.

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

This information is not applicable. The device is a biological indicator designed to detect sterilization failure based on the growth of Geobacillus stearothermophilus spores. The "ground truth" for these tests relates to microbiologic viability and efficacy of sterilization, not expert interpretation of medical images or clinical data. The assessment of "Pass/Failed" for the tests would be based on established scientific protocols for biological indicator evaluation, not expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for resolving discrepancies in expert interpretations of diagnostic data. The "tests" performed for this biological indicator involve standardized laboratory procedures with objective endpoints (e.g., spore growth/no growth, fluorescence detection).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable, as the device is not an AI-assisted diagnostic tool for human readers. It is a biological indicator for monitoring sterilization processes. Therefore, no MRMC study was conducted, and there is no "human reader improvement with AI" to report.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable in the context of an "algorithm only" performance. The device itself (the 3M™ Attest™ Rapid Readout Biological Indicator 1295 in conjunction with the 3M Attest™ Auto-reader 490H) operates autonomously to detect sterilization failure. Its performance is evaluated directly through the non-clinical tests listed. There is no human involved in the interpretation of the biological indicator's direct result (fluorescence as detected by the auto-reader).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for the in vitro performance tests is based on microbiological and physical measurements related to sterilization efficacy. This includes:

• The known viability and resistance characteristics of Geobacillus stearothermophilus spores.
• The controlled conditions of the sterilization cycles (full, half, fractional).
• The ability of the indicator to show growth when viable spores are present (lack of sterilization) and no growth when spores are killed (successful sterilization).
• Objective measurements of fluorescence and color change.

8. The Sample Size for the Training Set

This information is not applicable, as the device is not an AI/ML model that requires a "training set." It is a physical biological indicator.

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.

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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 STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles) and 100NX (Standard, Flex, Express and Duo cycles) systems.

The 3M Attest™ Rapid Readout Biological Indicator 1295 is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of STERRAD® 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 to pink upon exposure to vaporized hydrogen peroxide is located on the top of the 1295 BI utilizes the same fundamental technology that exists in current 3M Attest™ Rapid Readout and Super Rapid Readout BIs. The detection of fluorescence upon incubation of the 1295 BI in the 490H Autoreader indicates a sterilization failure.

This document describes a premarket notification (510(k)) for the 3M™ Attest™ Rapid Readout Biological Indicator 1295.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for the entire device as one might expect for a diagnostic or imaging AI. Instead, it presents a comparison to a predicate device, focusing on specific performance characteristics of the biological indicator (BI). The assumption is that the new device's performance matching the predicate device, especially for the additional sterilizer, meets the regulatory requirements.

Here's a table derived from the "Comparison to Predicate Device" section, identifying the characteristics (which serve as performance metrics for this type of device) and their reported values. The "acceptance criteria" here are implicitly that the device performs the same as the predicate device for these characteristics.

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 states: "No clinical data was included in this premarket application submission." This implies that testing was nonclinical. For biological indicators, this typically involves laboratory testing under controlled conditions rather than human patient data.

• Sample size for test set: Not explicitly stated in terms of number of biological indicators tested, but implied to be sufficient for nonclinical testing.
• Data provenance: Not explicitly stated, but the nature of the device (biological indicator) suggests lab-based, controlled experiments rather than clinical data from a specific country or retrospective/prospective collection related to human subjects.

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)

Not applicable. For a biological indicator, the "ground truth" is typically established by physical/chemical properties and microbiological testing (e.g., presence or absence of viable spores after sterilization, fluorescence detection) rather than expert human interpretation.

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

Not applicable, as no human expert interpretation or adjudication is mentioned for establishing the ground truth or evaluating performance.

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 for sterilization processes, not an AI or imaging device that would involve human readers or MRMC studies.

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

This concept is not directly applicable to a biological indicator. The "device" in this context is the BI itself, which functions by a chemical and biological reaction detected by an auto-reader. The performance described is inherent to the BI and its interaction with the sterilization process and the auto-reader, without a "human-in-the-loop" in the diagnostic sense. The comparison provided is for the BI's performance alone against its predicate.

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

The "ground truth" for a biological indicator is based on:

• Microbiological viability testing: Determining the presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions.
• Physical/chemical properties: Verifying D-value, survival time, kill time, and chemical indicator color change.
• The effectiveness of the sterilization process itself, often validated against established standards.

8. The sample size for the training set

Not applicable. This device is a biological indicator, not an AI/machine learning algorithm that requires a "training set."

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

Not applicable. No training set is involved.

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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 STERRAD® NX and 100NX systems.

The 3M Attest™ 1295 Rapid Readout Biological Indicator for Vaporized Hydrogen Peroxide Sterilization (pink cap, referred to hereinafter as the 1295 BI) is a self-contained biological indicator specifically designed for rapid and reliable routine monitoring of STERRAD® vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3M Attest™ Auto-reader 490H (hereinafter referred to as the 490H Auto-reader). The 1295 BI is a single-use device.

The Attest™ 1295 BI is 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 to pink upon exposure to vaporized hydrogen peroxide is located on the top of the cap.

The 1295 BI utilizes the same fundamental technology that exists in current 3M Attest™ Rapid Readout and Super Rapid Readout BIs. All Attest™ Rapid Readout and Super Rapid Readout BIs for steam utilize the a-glucosidase enzyme system, which is generated naturally within growing Geobacillus stearothermophilus organisms. The a-glucosidase enzyme in its active state is detected by measuring the fluorescence produced by the enzymatic hydrolysis of a non-fluorescent substrate. The resultant fluorescent by-product is detected in the 3M Attest™ 490H Auto-reader. The detection of fluorescence upon incubation of the 1295 BI in the 490H Auto-reader indicates a sterilization failure.

The 1295 BI is similar in design to the 3M Attest™ 1492V Super Rapid Readout Biological Indicator for Steam cleared as K121484 for dynamic-air-removal (prevacuum) steam sterilization cycles. Minor modifications were made to 1492V that resulted in the 1295 BI for STERRAD® vaporized hydrogen peroxide sterilization cycles.

The Attest™ Auto-reader 490H is similar in design to the Attest™ Auto-reader 490 that has been cleared for use with the Attest™ 1491 Super Rapid Readout Biological Indicator under K103277 and Attest™ 1492V Super Rapid Readout Biological Indicator under K121484.

The Attest™ Auto-reader 490H is designed to incubate at 60°C and automatically read the Attest™ 1295 BI for a fluorescent result within 4 hours. The fluorescent readout at 4 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days. The Auto-reader 490H is also designed to allow further incubation of the 1295 BI for an optional visual pH color change result of the growth media at 7 days.

The provided document describes the 3M Attest™ Rapid Readout Biological Indicator 1295 (BI) and 3M Attest™ Auto-reader 490H. The primary study presented is a substantial equivalence comparison to predicate devices, rather than a direct study demonstrating absolute performance against highly specific, quantitative acceptance criteria for all aspects of a typical diagnostic device. However, some performance characteristics are outlined, particularly in comparison to the predicate.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the new device as a set of a priori thresholds. Instead, it demonstrates substantial equivalence by comparing its characteristics and performance to legally marketed predicate devices, and against the FDA's Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions.

The table below summarizes the key performance characteristics mentioned for the Attest™ 1295 BI compared to its "Intended Use Predicate," the STERRAD® CycleSure® 24 BI (K123017).

Note for Auto-reader 490H: The document states the fluorescent readout at 4 hours met the FDA's requirement of > 97% alignment with the result after the conventional incubation time of 7 days. This is a key "acceptance criterion" for the rapid readout functionality, implying the accuracy of the 4-hour fluorescent result vs. the traditional 7-day visual result.

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

• Test Set Sample Size: The document states, "Multiple lots of Attest™ 1295 BIs were evaluated for performance." However, it does not provide a specific number or breakdown of the sample size (e.g., number of BIs, number of sterilization cycles, replicates) used for the resistance testing or reduced incubation time validation.
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission, the studies would likely be conducted in a controlled laboratory setting (e.g., 3M's R&D facilities) in the country of origin of the manufacturer (USA, St. Paul, MN). The data would be prospective as it involves controlled testing of the new device's performance against defined parameters.

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

• This type of device (biological indicator) relies on a biological process (spore inactivation) and a chemical reaction for ground truth, rather than expert review of images or clinical assessments.
• Ground Truth Establishment: The ground truth for the BI performance studies is based on established microbiological methods for assessing spore viability (e.g., lack of growth after incubation for positive control, confirmed kill for negative control) and comparison to the predicate device's known performance characteristics. No human "experts" in the sense of clinicians or radiologists are involved in establishing the ground truth for this device's function.

4. Adjudication Method

• Not applicable in the conventional sense. The "ground truth" for a biological indicator is determined by the growth or non-growth of spores, and the optical detection of fluorescence by the auto-reader. This is a direct, objective measurement, not subject to human interpretation or adjudication in the study itself.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with or without AI assistance. The 3M Attest system is a standalone biological sterilization indicator and auto-reader, not a diagnostic device involving human interpretation of complex medical cases.

6. Standalone Performance Study

• Yes, a standalone performance evaluation of the algorithm (or device's intrinsic function) was performed.
  • The "Reduced Incubation Time" validation demonstrates standalone performance, showing the 4-hour fluorescent readout reliably predicts the 7-day visual pH color change. This is the core "algorithm" of the rapid readout auto-reader.
  • The resistance characteristics (D-value, Survival/Kill Time) are also standalone performance metrics for the BI itself.
  • The comparison to the predicate device is also a form of standalone evaluation against a known standard.

7. Type of Ground Truth Used

• The ground truth used for performance evaluation is microbiological growth/non-growth of spores (indicating sterilization efficacy), and chemical pH change in growth media (for the traditional 7-day visual result).
• For the rapid readout function, the fluorescent signal's correlation to the 7-day visual pH change is the key ground truth.

8. Sample Size for the Training Set

• The document does not explicitly mention a training set in the context of an AI/ML algorithm development. This device uses a physiological detection mechanism (enzyme activity leading to fluorescence) rather than a machine learning model that would typically require a training set. The "development of a test cycle" and "evaluating multiple lots" suggests R&D and validation efforts, but not a distinct training set for an AI model.

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

• Not applicable, as a conventional AI/ML training set is not described or implied for this device. The development process would involve standard microbiology and engineering principles to ensure the BI and auto-reader accurately detect spore viability and fluorescence, respectively.

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