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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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3MTM Attest™ Super Rapid Steam Biological Indicator 1592:

Use the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 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 3MTM Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:

3MTM AttestTM Super Rapid Steam Challenge Pack 51582:

Use the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 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 3MTM Attest™ Mini Auto-reader 490M to qualify or monitor the following steam sterilization cycles:

| Cycle
Type | Exposure
Temperature | Exposure
Time |
|-------------------------------------------|-------------------------|------------------|
| Gravity Displacement | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 250°F (121°C) | 30 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 270°F (132°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 273°F (134°C) | 4 minutes |
| Dynamic-air-removal (pre-vacuum and SFPP) | 275°F (135°C) | 3 minutes |

3MTM AttestTM 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.

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 and 1492V, and 3M™ Attest Super Rapid Steam Biological Indicators 1592 at 60°C for a final fluorescent result at 24 minutes.

3MTM Attest™ 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 1592, at 60°C for a final fluorescent result at 24 minutes.

The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 is a self-contained biological indicator (BI) specifically designed for rapid and reliable qualification testing and routine monitoring of 250°F (121°C) dynamic-air-removal and gravity displacement steam sterilization processes and of dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities. The 1592 BI is used in conjunction with the 3MTM Attest™ Auto-reader 490 having software version 4.0.0 or greater, or a 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater, or a 3MTM Attest™ Mini Autoreader 490M.

The 1592 BI is a single-use device composed of a plastic sleeve containing a spore carrier and media ampoule, enclosed with a cap. On each 1592 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 1592 BI in the 490 Auto-reader, 490H Auto-reader, or the 490M Mini Auto-reader indicates a steam sterilization process failure.

The 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 is specifically designed to qualify and monitor dynamic-air-removal (pre-vacuum and SFPP) and gravity displacement steam sterilization processes at 250°F (121°C) and dynamic-air-removal steam sterilization processes at 270°F (132°C), 273°F (134°C), and 275°F (135°C) in healthcare facilities.

The 51582 Challenge Pack consists of multiple layers of medical index cards, some of which are die-cut to contain the monitoring products. The stacked cards are wrapped with sterilization wrap and secured with a label. The Challenge Packs are identical in design to the predicate device. Each 51582 Challenge Pack contains a 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and a 3M™ Attest™ Steam Chemical Integrator (Type 5 (Category i5) Integrating Indicator as categorized by ISO 11140-1:2014). The 3M™ Attest™ Chemical Integrator offers an immediate ACCEPT or REJECT reading. Each Challenge Pack has a process indicator on the outside of the device that changes from yellow to brown or darker when exposed to steam. 3MTM Attest™ 1592 BI controls are provided with the Challenge Packs.

The 1592 BI is specifically designed for rapid and reliable monitoring of the steam sterilization processes when used in conjunction with a 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater, a 3MTM 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 1592 BI in the 490, 490H, or the 490M Auto-reader indicates a steam sterilization process failure.

The provided document outlines the FDA's 510(k) clearance for several 3M™ Attest™ sterilization monitoring devices. The information primarily focuses on the substantial equivalence to predicate devices and presents a summary of non-clinical testing performed.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a table summarizing the performance tests, standards, purpose, acceptance criteria, and results for the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 (BI) and the 51582 Challenge Pack.

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

The document mentions various tests but does not specify the exact sample sizes (number of BIs or challenge packs) used for each test. It also does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. The reference to "FDA Guidance document¹" and ISO standards implies laboratory-based, controlled studies, which are typically prospective.

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 information is not provided in the document. For biological indicators, the "ground truth" is typically established by microbiological culture methods (e.g., observing growth/no growth of spores after sterilization exposure), which are objective and don't involve expert human interpretation in the same way as, for example, medical imaging.

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

This information is not applicable and therefore not provided in the context of biological indicators. The outcome of these tests (e.g., spore growth, fluorescent signal) is typically objectively measured rather than requiring human adjudication of results.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable to this type of device (biological indicators for sterilization monitoring). MRMC studies are relevant for AI-powered diagnostic tools where human readers are involved in interpreting results. The 3M™ Attest™ Auto-readers provide an automated, objective fluorescent readout, not an interpretation that human readers would assist with or improve upon. Therefore, an MRMC study was not done.

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

Yes, the device (the 3M™ Attest™ Auto-readers and Biological Indicators) operates in a standalone (algorithm only) manner for fluorescence detection. The "Reduced Incubation Time" test, for instance, validates the automated fluorescent result provided by the Auto-reader against conventional 7-day incubation. The Auto-readers detect the fluorescent by-product from enzymatic hydrolysis, indicating a sterilization process failure, without human interpretation of the result.

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

The ground truth for the biological indicator tests is established by microbiological methods. This involves:

• Spore Count: Direct enumeration of viable spores (e.g., plate counts).
• Spore Viability/Inactivation: Observing actual growth or no growth of the Geobacillus stearothermophilus spores after exposure to sterilization conditions, typically through traditional culture methods (7-day incubation is the conventional ground truth). The fluorescent signal from the Auto-reader is then compared to this microbiological outcome.

8. The sample size for the training set:

The document does not specify a separate "training set" sample size. The studies described are primarily performance validation studies for the biological indicators and auto-readers. For devices like these, which are not AI/ML algorithms designed to learn from data in the traditional sense, a distinct "training set" as understood in machine learning is not typically applicable or defined. The Auto-reader's algorithm is based on detecting a specific biochemical reaction and does not undergo continuous learning in the field.

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

As there is no explicitly defined "training set" for an AI/ML algorithm, this question is not applicable in the context of this device. The "ground truth" for the validation of the device's performance, as mentioned in point 7, is established through standard microbiological techniques.

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable as the device is a biological indicator for sterilization processes, not an AI/ML diagnostic tool for human readers.

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

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

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

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

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

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