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

3MTM AttestTM Auto-reader 490:

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

3MTM AttestTM Auto-reader 490H:

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

3MTM AttestTM Mini Auto-reader 490M:

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

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

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

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

4. Adjudication Method for the Test Set:

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

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

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

7. The Type of Ground Truth Used:

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

8. The Sample Size for the Training Set:

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

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

• Not Applicable. See point 8.

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3M™ Attest™ Super Rapid Readout Biological Indicator 1493:
Use the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
Cycle Type: Gravity Displacement, Exposure Temperature: 250°F (121°C), Exposure Time: 30 minutes
Cycle Type: Dynamic-air-removal (pre-vacuum and SFPP), Exposure Temperature: 250°F (121°C), Exposure Time: 15, 20, 30, or 35 minutes

3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG: Use the 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:
Cycle Type: Gravity Displacement, Exposure Temperature: 250°F (121°C), Exposure Time: 30 minutes

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

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

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

The 3MTM Attest™ Super Rapid Readout Biological Indicator (BI) 1493 is a self-contained biological indicator specifically designed for rapid and reliable qualification testing and routine monitoring of 121°C (250°F) dynamic-air-removal and gravity-displacement steam sterilization processes in healthcare facilities. The 1493 BI is used in conjunction with a 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, or a 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The 1493 BI is a single-use device composed of a plastic vial containing a spore carrier and media ampoule, enclosed with a color-coded cap. On each 1493 BI cap is a chemical process indicator that changes color from pink to light brown or darker when exposed to steam. The presence of fluorescence within the specified incubation time of the 1493 BI in the 490 Autoreader, the 490H Auto-reader, or the 490M Mini Auto-reader indicates a steam sterilization process failure.

The 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG is specifically designed to qualify and monitor gravity steam sterilization processes at 250°F (121°C) in healthcare facilities. The 1493PCDG Challenge Pack consists of a clear plastic shell with an opening to the cavity containing the monitoring products, all covered by a foil lid. The 1493PCDG is a single-use device. Each 1493PCDG Challenge Pack contains a 3M™ Attest™ Super Rapid Readout Biological Indicator (BI) 1493 and a 3M™ Attest™ Steam Chemical Integrator (CI) (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Steam Chemical Integrator offers an immediate ACCEPT or REJECT reading. A chemical process indicator is present on the cap of the 1493 BI and is visible through the clear plastic shell of the challenge pack. The process indicator on the BI cap turns color from pink to light brown or darker upon exposure to steam. 3M™ Attest™ 1493 BI controls are provided with the Challenge Pack.

The 1493 BI is specifically designed for rapid and reliable qualification testing and routine monitoring of steam sterilization process when used in conjunction with the 3MM Attest™ Auto-reader 490 having software version 4.0.0 or greater, a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3M™ Attest™ Mini Auto-reader 490M. The presence of fluorescence within the specified incubation time of the 1493 BI in the 490. 490H or 490M Auto-reader indicates a steam sterilization process failure.

Here's a breakdown of the acceptance criteria and the study information for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 and related devices, as extracted from the provided text:

1. Acceptance Criteria and Reported Device Performance

Biological Indicator (1493 BI)

Challenge Pack (1493PCDG)

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

• Biological Indicator (1493 BI):
  • Population, Positive Control Test, D-value, Z-value, Survival, Kill, Component Inhibition Studies, Reduced Incubation Time, Simulated Use: 3 lots of 1493 BIs were tested.
  • Holding Time Assessment: 2 lots of 1493 BIs were tested.
  • 490 and 490M Auto-reader Performance: 1 lot of 1493 BIs was evaluated.
• Challenge Pack (1493PCDG):
  • Resistance compared to AAMI 16 Towel PCD: 3 lots of 1493PCDG (containing 3 lots of 1493 BIs and 3 lots of 1243R CIs) were tested.
  • Resistance compared to standalone indicators: 3 lots of 1493PCDG (containing 3 lots of 1493 BIs and 3 lots of 1243R CIs) were tested.
  • Peel Force: 3 lots of 1493PCDG were tested for both unsterilized and pre/post sterilization conditions.

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective. However, tests were conducted according to recognized international (ISO) and US (FDA, AAMI, ASTM) standards, suggesting controlled laboratory environments.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "device" in question (biological indicators and challenge packs for sterilization) directly measures biological viability and physical characteristics. The ground truth for these types of devices is established through direct laboratory measurements, microbiological assays (like spore counts and viability after exposure), and physical property testing, rather than expert interpretation of images or clinical data. Therefore, there are no "experts" in the sense of medical professionals establishing a ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. As described above, the studies involve direct measurement and laboratory testing against predefined criteria in recognized standards, not subjective assessment requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The devices described here (biological indicators and auto-readers) are designed for direct, objective measurement of sterilization efficacy, not for human interpretation that would be enhanced by AI assistance.

6. Standalone Performance Study

Yes, standalone performance studies were done. All the tests listed in the tables (Population, D-value, Survival, Kill, Reduced Incubation Time, Simulated Use, etc., for the BI, and Resistance, Peel Force for the Challenge Pack) represent the standalone performance of the devices as they are intended to function without human interpretation. For example, the auto-readers automatically provide a fluorescent result, which is the direct output of the system.

7. Type of Ground Truth Used

• Biological Indicator (1493 BI): The ground truth is primarily established through direct microbiological testing (e.g., enumeration of viable spores, determination of D-values, survival, and kill times through controlled exposure to steam under defined conditions) and physical/chemical measurements (e.g., fluorescent or pH color change as an indicator of spore viability/growth). This is based on established sterilization science principles and standards.
• Challenge Pack (1493PCDG): The ground truth for the challenge pack's resistance is established by comparing its performance to recognized reference standards (e.g., AAMI 16 Towel PCD) and to standalone indicators, all under controlled sterilization conditions. Physical integrity is assessed via mechanical property testing (peel force).

8. Sample Size for the Training Set

Not applicable. The devices described are not AI/machine learning devices that require a separate "training set" of data to learn patterns or make predictions. They are physical and chemical indicators that operate based on biological and material science principles.

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

Not applicable, as there is no training set for these devices.

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

3M™ Attest™ Auto-reader (490):
The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.

3M™ Attest™ Auto-reader (490H):
The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.

3M™ Attest™ Mini Auto-reader (490M):
The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.

The 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD is designed to qualify and monitor dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities.

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

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

The provided text describes the 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD) and associated Auto-readers (490, 490H, 490M). This is a biological indicator system used to monitor steam sterilization processes, not an AI-based medical image analysis device. Therefore, many of the requested criteria (e.g., sample size for test set/training set, number of experts for ground truth, MRMC study, human-in-the-loop performance) are not applicable to this type of device and the information provided in the 510(k) summary.

However, I can extract the acceptance criteria and performance study details that are relevant to this biological indicator system, as described in the "Nonclinical Comparison to the Predicate Device" section.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

For the resistance testing:

• Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested.
• These contained three lots of 1492V BIs and three lots of 1243R CIs.
• They were tested side by side with standalone indicators (1492V BIs and 1243R CIs) and with the AAMI 16 Towel PCD also containing 1492V BIs and 1243R CIs.
  The exact number of individual devices or runs per lot is not specified, but for biological indicator testing, a standard number of replicates (e.g., 10-20) per test condition is typically used.
• Data Provenance: The study appears to be a prospective laboratory-based performance study, conducted by the manufacturer (3M Company) in the U.S. (based on company location and FDA submission).

For the peel force testing:

• Three lots of 3M™ Attest™ Super Rapid Steam Clear Challenge Pack 1492PCD were tested.
  The exact number of units per lot is not specified.

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

• This information is not applicable. For biological indicator systems, "ground truth" is established by the known biological response of the indicator (e.g., spore kill/growth) under defined sterilization conditions, rather than human expert interpretation of images. The performance is objectively measured in a laboratory setting.

4. Adjudication Method for the Test Set

• This information is not applicable, as there is no human interpretation or subjective assessment to adjudicate. The fluorescence readings from the Auto-reader are objective, and chemical indicator endpoints are also designed for clear visual determination.

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 system, not an AI-based medical image analysis device involving human readers.

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

• This information is not directly applicable in the AI sense. However, the performance of the "algorithm" (the biological indicator system and auto-reader) is inherently standalone in its function of detecting biological indicator results (fluorescence). The results of the Auto-readers are objective and do not require human interpretation.

7. The Type of Ground Truth Used

• The ground truth for biological indicators is the presence or absence of viable Geobacillus stearothermophilus spores after exposure to sterilization conditions. This is determined by the biological response of the indicator (showing growth/fluorescence for live spores, no growth/no fluorescence for killed spores) under controlled laboratory conditions, correlated with known sterilization efficacy.

8. The Sample Size for the Training Set

• This is not applicable, as this is not an AI/ML device that requires a training set. The device's performance is based on its physical/chemical/biological design and validated through non-clinical laboratory testing.

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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3M™ Attest™ Super Rapid Readout Biological Indicator 1492V:

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

3M™ Attest™ Auto-reader 490:

The 3M™ Attest™ Auto-reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.

3M™ Attest™ Auto-reader 490H:

The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60℃ for a final fluorescent result at 24 minutes.

3M™ Attest™ Mini Auto-reader 490M:

The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.

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, the 3M™ Attest™ Auto-reader 490H (having software version 4.0.0 or greater), or the 3M™ Attest™ Mini Auto-reader 490M to qualify or monitor dynamic-air-removal steam sterilization cycles at 132°C, 134°C and 135°C.

The 1492V BI is a single-use device composed of a plastic vial containing a spore carrier and media ampoule, enclosed with a color-coded 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 Autoreader, the 490H Auto-reader (software version 4.0.0 or greater), or the 490M Mini Autoreader indicates a sterilization failure.

The provided text describes the acceptance criteria and study results for the 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V and associated auto-readers (490, 490H, 490M). This is for a 510(k) submission (K241710) to expand the indications for use to include additional exposure temperatures and times for dynamic-air-removal steam sterilization cycles.

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

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

• ISO 11138-1:2017 | Acceptance criteria met |
  | Kill for 134°C (273°F) cycles | 1492V BI | FDA Guidance¹, ISO 11138-1:2017 and ISO 11138-3:2017 | Not explicitly stated for Kill alone; part of evaluating resistance characteristics | Meets the requirements for Calculated kill time*
• ISO 11138-1:2017 | Acceptance criteria met |
  | Reduced Incubation Time for 134°C (273°F) cycles | 1492V BI | FDA Guidance¹, ISO 11138-1:2017 and ISO 11138-8:2021 | To validate the reduction in incubation time from 7 days (visual color change) to 24 minutes (fluorescent readout) and 48 hours (visual pH color change) | Meets FDA's requirements for Reduced Incubation Time with > 97% alignment with the conventional incubation time of 7 days for the following readout times:
  • Fluorescent result in 24 minutes
  • Visual pH color change result in 48 hours | Acceptance criteria met |
  | Holding Time Assessment for 134°C (273°F) cycles | 1492V BI | FDA Guidance¹, ISO 11138-1:2017 and ISO 11138-3:2017 | To evaluate the effect of the labeled holding time on the D-value | D-value must be within +/- 20% of the initial D-value calculated per ISO 11138-1:2017 | Acceptance criteria met |
  | Attest 1492V Simulated Use | 1492V BI | FDA Guidance¹ | Verification of performance in claimed cycles | BI performs as intended in claimed cycles | Acceptance criteria met |

Note: The source document refers to "FDA Guidance for Industry and FDA Staff, Biological Indicator (BI) Premarket Notification [510(k)] Submissions, October 4, 2007" as "FDA Guidance¹".

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

• Sample Size for Test Set:

  • Positive Control, D-Value, Survival, and Kill for 134°C cycles: Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were tested. The specific number of BIs per lot for testing isn't explicitly stated but would be determined by the referenced ISO standards (ISO 11138-1:2017 and ISO 11138-3:2017).
  • Reduced Incubation Time for 134°C cycles: Three lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were tested. (Specific number of BIs per lot determined by ISO 11138-8:2021).
  • Holding Time Assessment for 134°C cycles: One lot of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V was tested. (Specific number of BIs per lot determined by ISO 11138-1:2017 and ISO 11138-3:2017).
  • Simulated Use Testing: Four lots of 3M™ Attest™ Super Rapid Readout Biological Indicators 1492V were evaluated. (Specific number of BIs per lot determined by FDA Guidance¹).

• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission by a U.S. company (3M Company, St. Paul, MN), it can be inferred the testing was likely conducted in a controlled laboratory environment aligned with U.S. regulatory requirements and standards, implying a prospective testing approach for these performance studies.

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 type of device (biological indicator for sterilization) does not involve human expert interpretation of images or other subjective data for ground truth establishment. The ground truth is objective, based on the growth or non-growth of microorganisms (fluorescence and visual pH change), and measured by an auto-reader and laboratory methods (plating for D-value, survival, and kill). Therefore, experts in the sense of radiologists providing interpretations are not applicable here. The "experts" would be the laboratory personnel performing the sterility testing and enumeration, governed by the specified ISO standards and FDA guidance. Their qualifications are inherent in following these validated procedures.

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

• Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments where human consensus is needed (e.g., image interpretation). This is a biological and physical performance study with objective endpoints (fluorescence, pH change, microbial growth counts). Therefore, no human adjudication method was employed or necessary. The "adjudication" is inherent in the quantitative and qualitative results generated by the auto-readers and laboratory microbiological techniques according to the established standards.

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

• No, an MRMC comparative effectiveness study was not done. This device is a biological indicator for sterilization monitoring, not an AI-assisted diagnostic tool that requires human reader interpretation. The performance is assessed based on the BI's ability to accurately indicate sterilization success or failure.

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

• Yes, in a sense. The core of the device's function is the biological indicator itself and the auto-reader's algorithmic interpretation of the fluorescence. The performance evaluation metrics (D-value, survival, kill, reduced incubation time, holding time assessment) are "standalone" in that they assess the intrinsic performance of the BI and auto-reader system without a human repeatedly making the final decision based on their output. The auto-reader's "algorithm" automatically reads the fluorescent result. The final visual pH change is a secondary, optional, human-observable check, but the primary rapid readout is automated.

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

• The ground truth for this biological indicator is established by microbiological methods and physical-chemical principles as defined by the referenced ISO standards (ISO 11138-1, ISO 11138-3, ISO 11138-8) and FDA guidance specific to biological indicators.
  • For D-value, survival, and kill times, the ground truth is determined by the actual microbial load reduction after exposure to various sterilization conditions. This involves traditional microbiology techniques like plate counting to determine the number of viable spores remaining after exposure.
  • For the auto-reader's performance (fluorescence and pH change), the ground truth is the presence or absence of viable (germinated and metabolically active) spores, confirmed by the microbiological culture. A positive result (fluorescence/pH change) indicates spore survival, meaning sterilization failure; a negative result indicates spore death, meaning sterilization success.

8. The sample size for the training set

• The document describes a 510(k) submission for an expanded indication for use of an existing device. It discusses non-clinical performance testing (verification and validation) for the updated indications. It does not mention a "training set" in the context of an AI/ML model, as this is a traditional medical device (biological indicator and auto-reader) whose function is based on biological and chemical reactions, not adaptive algorithms trained on large datasets. Therefore, the concept of a "training set" in this context is not applicable.

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

• As explained above, the concept of a "training set" is not applicable to this submission, as it's not an AI/ML device being developed and trained. The document focuses on demonstrating the device's performance against established standards and its equivalence to a predicate device.

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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.

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Use the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in the follow 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 cvcles),

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) SteroScope® Sterilization System

The 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD is designed as a standard method of rapid and reliable routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes.

The 1295PCD Challenge Pack consists of a clear plastic shell, with two individual channels allowing for air removal and sterilant penetration. Those two individual channels connect to a cavity containing the monitoring products and all are covered by a foil lid. The 1295PCD is a single-use device.

Each 1295PCD Challenge Pack contains a 3M™ Attest™ Rapid Readout Biological Indicator (BI) 1295 (pink cap) and a 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (CI) 1348. The 1348 CI verifies that the stated values for the three critical parameters of exposure time, temperature, and concentration of vaporized hydrogen peroxide have been achieved and offers an ACCEPT or REJECT reading. The 1295 BI is specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3MTM Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H. The presence of fluorescence within the specified incubation time for the 1295 BI in the 490, 490M, or the 490H Auto-reader indicates a sterilization process failure. A printed chemical process indicator is present on the cap of the 1295 BI and is visible through the clear plastic shell of the challenge pack. The process indicator turns color upon exposure to vaporized hydrogen peroxide and is used by the customer to verify that the challenge pack was exposed to vaporized hydrogen peroxide.

The document describes the non-clinical testing performed to determine the performance of the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD. This device is a sterilization biological indicator used for routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes. The study's focus was to demonstrate performance in a newly claimed sterilizer, the SteroScope® Sterilization System, as the submission device is otherwise identical to a previously cleared predicate device (K233814).

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

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance: The document does not explicitly state the specific number of units (sample size) used for each test (Full Cycle Performance and Incomplete Cycle Performance). It only indicates that "nonclinical testing was performed." The data provenance is nonclinical testing conducted by the manufacturer (3M Company), specifically for the purpose of this 510(k) submission, and appears to be prospective testing for the additional indication. The country of origin of the data is not specified, but the submission is to the U.S. FDA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. For this type of device (sterilization biological indicator), "ground truth" is typically established by the physical and chemical parameters of the sterilization process itself, rather than human expert interpretation of images or data. The "ground truth" is whether the sterilization cycle was successful or failed based on controlled conditions.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. The "readout" of the biological indicator (fluorescence positive/negative) and chemical indicator (color change/b* value) are direct measurements/observations, not subject to human adjudication in the typical sense of medical imaging interpretation.

4. 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 physical indicator for sterilization, not an AI-powered diagnostic tool requiring human interpretation. Therefore, an MRMC study is not relevant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device's performance is inherently "standalone" in function, as it is a physical indicator reacting to a sterilization process. The interpretation of the results from the biological indicator is done by an auto-reader (3M™ Attest™ Auto-reader 490, 490M, or 490H), which provides a definitive "positive" or "negative" fluorescent response. The chemical indicator also provides a direct visual result. There is no "algorithm only" performance that would be separate from the physical functioning of the device and its dedicated reader.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for this device's performance is based on the controlled efficacy of the sterilization process. "Full cycle" conditions represent a successful sterilization based on established standards, intending for the BI to show no growth/negative fluorescence and the CI to show an "ACCEPT" result. "Incomplete cycle" conditions represent a failed sterilization, intending for the BI to show growth/positive fluorescence and the CI to show a "FAIL" result. This is a form of empirical validation against defined physical and biological outcomes under controlled laboratory conditions, rather than expert consensus or pathology on patient data.

7. The sample size for the training set: Not applicable and not mentioned. This is a physical device, a biological and chemical indicator, not an AI/machine learning model that requires a training set.

8. 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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As a Sterilizer Monitoring Device, the 3M™ Attest™ eBowie-Dick Test Card 10135 and 3M[™ Attest™ eBowie-Dick Card Holder 10135CH is used in conjunction with the 3MTM Attest™ eBowie-Dick Auto-reader 1190 to monitor the equipment performance of steam sterilizers each. day, as well as after a steam sterilizer repair. The 3MTM Attest™ eBowie-Dick Test Card 10135 will detect steam penetration as a means of measuring air removal efficiency. The 3M™ Attest™ eBowie-Dick Test Card 10135 and 3MTM Attest™ eBowie-Dick Card Holder 10135CH is designed for testing air removal efficiency of 132°C (270°F). 134°C (273°F), and 135°C (275°F) for 3.5 minute test cycles in dynamic-air-removal steam sterilizers with chamber volumes greater than 54L (approximately 2 cubic feet).

The 3MTM Attest eBowie-Dick Auto-reader is designed to automatically interpret, store, and display the result of the 3MTM Attest™ eBowie-Dick Test Card.

The 3M™ Attest™ eBowie-Dick Test Card consists of a laminated construction with a lead-free steam-sensitive chemical indicator positioned at the end of a lumen challenge. The 3MTM Attest™ eBowie-Dick Test Card undergoes a change in electrical resistance upon exposure to saturated steam. The test card includes a lumen challenge which is designed to restrict air removal and steam perfusion. At the completion of a Bowie-Dick test cycle, the resistance of the 3MTM Attest™ eBowie-Dick Test Card is read out using the 3MTM Attest™ eBowie-Dick Autoreader. The 3M™ Attest™ eBowie-Dick Test Card will reach a PASS value when adequate air removal and steam profusion is achieved. An air removal failure and or a steam penetration failure is indicated by a FAIL result.

The 3MTM Attest™ eBowie-Dick Card Holder is a reusable sterilizable plastic container for the Test Card which serves to support the laminated construction of the Test Card during the vacuum and pressure cycles of the air removal test, as well as anchor the Test Card in place inside the sterilization chamber through the increased mass of the Card Holder plus Test Card combination.

The 3M™ Attest™ eBowie-Dick Auto-reader is a wall powered electrical resistance measurement device which receives a processed Test Card via the card slot and contains pairs of internal mechanical contacts to probe the metallic contact pads on the Test Card. The Autoreader detects and confirms proper insertion of the Test Card, measures the PANI sensor electrical resistance, and returns a visible PASS, FAIL, or ERROR state indication to the user. The Auto-reader utilizes embedded firmware to detect and read the resistance of a Test Card. The device also includes USB or BLE connectivity for integrating with the optional 3M™ AttestTM Connect Software platform.

This document describes the 3M™ Attest™ eBowie-Dick Test, a system designed to monitor steam sterilizer performance for air removal efficiency.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the Special Controls outlined in the document, reflecting the requirements for non-clinical performance testing. The reported device performance is based on the summary of bench studies provided.

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

The document does not explicitly state the specific sample sizes for each performance test (test sets for sensitivity, specificity, accuracy, precision, endpoint stability, etc.). It describes the types of tests conducted but not the number of units or cycles tested within each.

The data provenance is retrospective (bench studies already conducted) and likely originated from 3M's internal laboratories based in the USA (St. Paul, MN). The data is entirely non-clinical.

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

The document does not mention the use of human experts to establish ground truth for the test set in the context of interpreting the eBowie-Dick test results. The device is designed for automatic interpretation. The ground truth for the performance testing appears to be based on physical measurements and established scientific principles of sterilization (e.g., inadequate vs. adequate cycles, presence of non-condensable gasses, comparison to ISO 11140:2007-5 Standard Test Pack).

4. Adjudication Method for the Test Set

Not applicable. The device's automated interpretation (Pass/Fail/Error via auto-reader) means there is no human adjudication process described or required for its primary function. Ground truth determination for performance studies would be based on instrument readings and physical conditions.

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

No. This device is an automated physical/chemical indicator system. It does not involve human readers interpreting images or data where a comparative effectiveness study with and without AI assistance would be relevant. The benefit is explicitly stated as increased testing sensitivity with a digital measurement and reduced false results/repeat testing with an automatic reader, suggesting it is intended to replace or significantly simplify manual interpretation or older methods.

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

Yes. The entire performance testing described, particularly for sensitivity, specificity, accuracy, precision, and endpoint stability, assesses the performance of the eBowie-Dick Test Card and Auto-reader system in a standalone capacity. The Auto-reader automatically interprets the card's resistance to provide a Pass, Fail, or Error result. Human interpretation is not part of the core performance evaluation of the device itself.

7. Type of Ground Truth Used

The ground truth used for performance testing (e.g., sensitivity, specificity) is based on:

• Physical Conditions: Deliberately created "inadequate" (e.g., specific air pocket sizes, insufficient vacuum/pressure) and "adequate" sterilization cycles.
• Comparison to Reference Standards: Performance compared to the "Standard Test Pack as defined in ISO 11140:2007-5."
• Known States: Testing the sensor in known adequate and inadequate cycles to show expected pass/fail results.
• Instrument Calibration/Verification: Verified resistance values for Auto-reader accuracy.

8. Sample Size for the Training Set

The document does not provide a specific sample size for a "training set." The device utilizes embedded firmware with "predefined thresholds" for interpreting resistance measurements. This suggests the thresholds were established through internal development and testing, but the explicit size of any dataset used to develop or "train" these thresholds is not disclosed.

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

Given the nature of the device (measuring electrical resistance that changes with saturated steam exposure), the "ground truth" for establishing the predefined thresholds would likely involve:

• Controlled Laboratory Experiments: Exposing test cards to precisely controlled steam sterilization cycles (adequate and various levels of inadequate) in laboratory settings.
• Physical Measurements: Correlating the electrical resistance measurements from these controlled exposures with the known physical conditions (e.g., presence/absence of saturated steam, degree of air removal failure).
• Engineering Principles: Establishing the resistance values that correspond to a successful steam penetration (Pass) and those that indicate a failure (Fail). This would be based on the scientific principles of the chemical indicator's electrical resistance change upon exposure to saturated steam.
• Comparison to Existing Standards: Aligning the "Pass" and "Fail" thresholds to be equivalent to the performance of established Bowie-Dick tests, such as those compliant with ISO 11140:2007-5.

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3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD): Use the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H as a standard method of routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes in the follow systems: STERRAD 100S® Sterilization System, STERRAD NX® Sterilization System (Standard and Advanced cycles), STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cvcles), 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, Flexible, and Fast Non Lumen cycles). V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles)

3M™ Attest™ Auto-reader (490): The 3M™ Attest™ Auto reader 490 is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V, and 1592 at 60°C for a final fluorescent result at 24 minutes.

3M™ Attest™ Auto-reader (490H): The 3M™ Attest™ Auto-reader 490H is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295, 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.

3M™ Attest™ Mini Auto-reader (490M): The 3M™ Attest™ Mini Auto-reader 490M is designed to incubate and automatically read 3M™ Attest™ Rapid Readout Biological Indicators 1295 and 3M™ Attest™ Super Rapid Readout Biological Indicators, catalog numbers 1491, 1492V and 1592, at 60°C for a final fluorescent result at 24 minutes.

The 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD is designed as a standard method of rapid and reliable routine monitoring and performance qualification of vaporized hydrogen peroxide sterilization processes. The 1295PCD Challenge Pack consists of a clear plastic shell, with two individual channels allowing for air removal and sterilant penetration. Those two individual channels connect to a cavity containing the monitoring products and all are covered by a foil lid. The 1295PCD is a single-use device. Each 1295PCD Challenge Pack contains a 3M™ Attest™ Rapid Readout Biological Indicator (BI) 1295 (pink cap) and a 3MTM Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator (CI) 1348. The 1348 CI verifies that the stated values for the three critical parameters of exposure time, temperature, and concentration of vaporized hydrogen peroxide have been achieved and offers an ACCEPT or REJECT reading. The 1295 BI is specifically designed for rapid and reliable routine monitoring of vaporized hydrogen peroxide sterilization processes when used in conjunction with the 3MTM Attest™ Autoreader 490 having software version 4.0.0 or greater or a 3M™ Attest™ Mini Auto-reader 490M or a 3M™ Attest™ Auto-reader 490H. The presence of fluorescence within the specified incubation time for the 1295 BI in the 490, 490M, or the 490H Auto-reader indicates a sterilization process failure. A printed chemical process indicator is present on the cap of the 1295 BI and is visible through the clear plastic shell of the challenge pack. The process indicator turns color upon exposure to vaporized hydrogen peroxide and is used by the customer to verify that the challenge pack was exposed to vaporized hydrogen peroxide.

Here's an analysis of the acceptance criteria and supporting studies for the 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD) and associated Auto-readers, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details from the Provided Document:

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

• PCD Resistance Characterization: Three lots of 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (containing three lots of 1295 BIs and three lots of 1348 CIs) were tested side-by-side with standalone 1295 BIs and 1348 CIs. The document does not specify the exact number of units or replicates within each lot.
• PCD Functionality (Pass Cycle): Not explicitly stated, but implies the same sample size as Resistance Characterization.
• PCD Functionality (Fail Cycle): Not explicitly stated, but implies the same sample size as Resistance Characterization.
• PCD Peel Force: Three lots of 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD were tested. The exact number of units or replicates is not specified.
• Cycle Performance: Four lots of 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD were subjected to simulated use testing. The exact number of units or replicates is not specified.
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective as it involves active testing of newly manufactured lots of the device and comparing them against standards.

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

The document describes non-clinical performance testing of mechanical and biological indicators. There is no mention of human experts being used to establish ground truth for the performance of the sterilization indicators. The ground truth for biological indicator performance (survival/kill) would be determined by microbiological culturing and fluorescence detection as described in the mechanism of action. Chemical indicator performance is determined by visual color change and quantitative measurement of critical parameters.

4. Adjudication Method for the Test Set

Not applicable, as this was non-clinical laboratory testing, not a study involving human interpretation or subjective judgment that would require adjudication.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least not mentioned as part of this submission).
• The device is a sterilization process indicator and auto-reader system; its performance is evaluated objectively based on biological and chemical reactions, not human diagnostic accuracy.

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

• No, the concepts of "algorithm only" or "standalone" performance in the context of AI are not directly applicable to this device.
• The 3M™ Attest™ Auto-readers (490, 490H, 490M) are designed to automatically read the biological indicators for a final fluorescent result at 24 minutes. This is an automated detection system. However, it's not described as an "AI algorithm" in the common sense for diagnostic imaging or similar applications. Its performance is intrinsically "standalone" in its reading function, without human interpretation of the fluorescent signal, but the overall system involves human handling of the challenge pack and interpretation of the auto-reader display.

7. Type of Ground Truth Used

The ground truth used for the non-clinical tests would be:

• Microbiological Growth/No Growth: For biological indicators (BIs), the definitive ground truth for sterilization effectiveness is the absence of microbial growth after exposure to a sterilization process, and growth after inadequate exposure or no exposure. This is typically determined by standard microbiological culture methods. The document mentions the 1295 BI utilizes an enzyme system and fluorescence measurement, with an optional pH indicator, indicating these are the readouts used, which are correlated to the viability of Geobacillus stearothermophilus spores.
• Known Sterilization Parameters: For chemical indicators (CIs) and for challenging the system, the ground truth is established by precisely controlling sterilization parameters (time, temperature, concentration of vaporized hydrogen peroxide) in a laboratory setting to create "pass" and "fail" conditions.
• Mechanical Measurement: For peel force, the ground truth is based on physical measurement using calibrated equipment.

8. Sample Size for the Training Set

The document does not describe the development or training of an AI algorithm in the traditional sense, so there is no mention of a training set sample size. The Auto-readers are described as devices that incubate and automatically read biological indicators, implying a fixed automated process rather than a machine learning model that would require a distinct training set.

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

As there is no mention of an AI training set, this question is not applicable based on the provided document. The functionality of the auto-readers is based on detecting fluorescence and relating it to biological indicator activity, which is a deterministic process rather than a learned one from a training set.

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3M™ Clarity™ Aligners with Quick Attachments are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

3M™ Clarity™ Aligners with Quick Attachments, is a clear plastic sequential aligner that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. 3M™ Clarity™ Aligners with Quick Attachments utilize the option of pre-formed and pre-cured attachments offering a more accurately shaped attachment. Attachments help create forces on the tooth which can assist aligner retention or optimized aligner force system for tooth movement. 3M Clarity Aligners with Quick Attachments provide the option to form the attachments via an empty attachment template that is filled with adhesive and cured on the teeth or by pre-formed 3D printed custom attachments. The aligners, with or without attachments, are for orthodontic treatment of malocclusions.

The provided document describes the 3M™ Clarity™ Aligners with Quick Attachments and its substantial equivalence to a predicate device, 3M™ Clarity™ Aligners (K231464).

Acceptance Criteria and Device Performance:

The document states that the proposed Quick Attachment alternative attachment delivery mechanism completed functional and performance testing, including but not limited to abrasion, bond strength, flexural strength, and stain resistance. The conclusion drawn is that the alternative Quick Attachment delivery mechanism does not impact the safety and effectiveness profile of the 3M™ Clarity™ Aligners and is substantially equivalent to the predicate device.

However, the document does not provide a specific table of acceptance criteria with numerical targets and the reported device performance against those targets. It only states that testing was performed and that the device met the safety and effectiveness profile.

Regarding the study that proves the device meets the acceptance criteria, the following information is available from the document:

This document summarizes a 510(k) premarket notification, which establishes substantial equivalence, implying that the new device is as safe and effective as a legally marketed predicate device. In this context, detailed "acceptance criteria" and "study results" in the format typically seen for a new drug or high-risk medical device might not be explicitly outlined with quantitative data in this summary. Instead, the focus is on demonstrating that the modifications (Quick Attachments) do not alter the safety and efficacy profile from the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The specific numerical acceptance criteria and detailed quantitative results for abrasion, bond strength, flexural strength, and stain resistance are not provided in this 510(k) summary.

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

The document does not specify the sample size used for the functional and performance testing for the Quick Attachments. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The tests mentioned (abrasion, bond strength, flexural strength, stain resistance) are typically objective laboratory or mechanical tests rather than those requiring expert ground truth in a clinical sense.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided in the document, as the tests described are objective performance tests.

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

No MRMC comparative effectiveness study is mentioned. This type of study is more relevant for diagnostic imaging devices where human readers interpret results.

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

Not applicable. The device is a physical orthodontic product, and the testing described relates to its physical and material properties. There is no mention of an algorithm or AI component in this context.

7. Type of Ground Truth Used:

The "ground truth" for the functional and performance testing (abrasion, bond strength, flexural strength, stain resistance) would be the established scientific and engineering standards and methods for measuring these material properties. It is not an expert consensus, pathology, or outcomes data in the clinical sense for this type of device.

8. Sample Size for the Training Set:

Not applicable. The document describes functional and performance testing of a physical device component, not an AI or algorithm that would require a training set.

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

Not applicable, as there is no training set mentioned or implied for this device.

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3M™ Clarity™ Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force. 3M™ Clarity™ Aligners-Flex) are a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. The present Premarket Submission is for the simplification in the number of formulations of the aligner material. This simplification allows for streamlined manufacturing processes so that both 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force can be composed of the same material with differing flexibilities. The aligners will still be named 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex).

3M is offering a treatment plan with two different aligner flexibilities where the dental health professional will determine which degree of flexibility to use during the treatment plan. 3M Clarity Aligners-Flex is designed to be more flexible thereby increasing patient comfort and ease of insertion and removal. 3M Clarity Aligners-Force is designed to be more rigid increasing the force persistence. 3M will continue to offer the option of combination treatment plans where both 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force can be used.

A dental health professional (e.g., orthodontist or dentist), prescribes 3M™ Clarity™ Alieners (3MTM Clarity™ Aligners-Force, 3MTM Clarity™ Aligners-Flex) based on an assessment of the patient's teeth and determines a course of treatment with the system. Patient data is collected via intra-oral scanning or taking physical impressions. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved. 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. The dental care professional monitors treatment from the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

This document is a 510(k) Premarket Notification for the 3M™ Clarity™ Aligners. The core purpose of the submission is to demonstrate substantial equivalence to a previously cleared predicate device (K211190) rather than to present a study proving the device meets specific acceptance criteria for clinical performance that would allow it to be used as a standalone diagnostic or screening tool.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance testing conducted to show that the new material formulation of the aligners does not negatively impact safety and effectiveness compared to the predicate device. The information provided heavily focuses on bench testing and biocompatibility rather than clinical efficacy studies.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of acceptance criteria with numerical targets and corresponding device performance values in detail. Instead, it states that "All performance testing shows acceptable results for all tested samples." The acceptance is based on demonstrating that the subject device's performance is comparable or equivalent to the predicate device, especially considering the change in material.

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

The document does not specify the exact sample sizes for each type of performance testing (translucency, abrasion, etc.). It generally refers to "all tested samples" from "bench testing." The data provenance is internal to 3M™ Company, arising from their in vitro and ex vivo laboratory testing. This is retrospective data collected for regulatory submission purposes. There is no information about country of origin for the data that would be relevant to clinical studies in this context.

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

This question is not directly applicable in the context of this 510(k) submission, as it relates to clinical efficacy studies or diagnostic performance evaluations. The "ground truth" here is established by the accepted scientific and engineering principles for material and device performance testing. For biocompatibility, a "Diplomate of the American Board of Toxicology" assessed the safety.

4. Adjudication Method for the Test Set:

Not applicable, as this is primarily a bench testing and material change submission, not focused on human interpretation of clinical data in a test set.

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 submission is for an orthodontic aligner device, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a physical medical device, not a software algorithm. While software is used in the manufacturing process, the submission does not present performance data for the software itself in a standalone context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance testing is based on established scientific and engineering standards for material properties and device functionality, often evaluated against the previous (predicate) device's performance, as well as relevant ISO standards (e.g., ISO 10993 for biocompatibility) and FDA guidance documents. For biocompatibility, the assessment by a board-certified toxicologist serves as the expert evaluation.

8. The Sample Size for the Training Set:

Not applicable. This submission focuses on a physical device and its material properties, not an AI algorithm requiring a training set.

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

Not applicable, as there is no training set for an AI algorithm.

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