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Terragene® Bionova® BT20 Biological Indicator is a Self-Contained Biological Indicator (SCBI) intended for routine monitoring of the efficacy of the following steam sterilization processes:

• Gravity-displacement Steam Sterilization Cycles

• 121 °C, 30 minutes
• 132 °C, 25 minutes
• 132 °C, 15 minutes
• 132 °C, 10 minutes
• 134/135 °C, 10 minutes

• Vacuum-assisted Steam Sterilization Cycles

• 121 °C, 20 minutes
• 132 °C, 4 minutes
• 134/135 °C, 3 minutes

Terragene® Bionova® BT20 provides a final result after a 24 hour incubation at 60 ± 2 °C.

Terragene® Bionova® BT20 Biological Indicators are single-use Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a filter paper spore carrier inoculated with a minimum of 10⁶ viable Geobacillus stearothermophilus ATCC® 7953 spores and a glass ampoule containing purple culture medium, enclosed with a plastic colored cap and a barrier permeable to steam. The culture medium contains a pH indicator that changes color upon acidification by the metabolism of living spores. On each BT20 Biological Indicator there is a propylene label printed with a chemical process indicator that changes from pink to brown when exposed to steam.

Final results: 24-hour readout after incubation at 60 °C. If the sterilization process was successful, culture medium will remain purple. If sterilization was not successful, culture medium will turn to yellow during incubation, thus indicating the presence of live G. stearothermophilus spores.

This document describes the acceptance criteria and the study proving the Terragene® Bionova® BT20 Biological Indicator meets these criteria.

It's important to note that this device is a Biological Indicator for sterilization, not an Artificial Intelligence (AI) or medical imaging device. Therefore, some of the requested information (like multi-reader multi-case studies, ground truth establishment for AI training, etc.) is not applicable. The information provided focuses on the rigorous testing required for biological indicators to demonstrate their efficacy in monitoring sterilization processes.

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

The following table summarizes the acceptance criteria and the "Results" कॉलम में "Passed" यह बताता है कि डिवाइस ने उन सभी मापदंडों को सफलतापूर्वक पूरा किया है।

• ≥ 10⁵ CFU/BI unit (FDA Guidance, ISO 11138-3:2017). | Passed |
  | Resistance Characteristics Study | Evaluate the resistance characteristics (D-value, Z-value, Survival Time, Kill Time). | - D-value₁₂₁°C: ≥ 1.5 minutes
• D-value₁₃₂°C: ≥ 10 seconds
• D-value₁₃₅°C: ≥ 8 seconds
• Z-value: ≥ 10°C
• Minimum Expected Survival Time₁₂₁°C: ≥ 5 minutes
• Minimum Expected Survival Time₁₃₂°C: ≥ 1 minute
• Minimum Expected Survival Time₁₃₄/₁₃₅°C: ≥ 40 seconds
• No negative results at Minimum Expected Survival Time.
• No positive results at Maximum Expected Kill Time. | Passed |
  | Recovery Protocols: Recovery Medium Test | Test suitability of the culture medium. | - All inoculated samples show positive result (color change to yellow) after 7-day incubation at 60°C.
• Negative controls (uninoculated) show negative result (medium remains purple) after 7-day incubation at 60°C. | Passed |
  | Carrier and Primary Packaging Materials Evaluation | Evaluate effect of materials on spore viability and suitability. | - No "no growth" in exposed carrier samples.
• No "no growth" in unexposed carrier samples.

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Celerity 5 HP Biological Indicator:
The Celerity 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

• Lumen, Non Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems
• Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.

Celerity 5 HP Challenge Pack:
The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 20 HP Biological Indicator
The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

• Lumen, Non-Lumen, Fast Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems.
• Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear
• Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear®

When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes.

Celerity 20 HP Challenge Pack
The Celerity 20 HP Challenge Pack is intended for qualification testing of the V-PRO® Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 5 HP BI
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, STERIS Celerity Incubator, within 5 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

Celerity 5 HP Challenge Pack
The Celerity 5 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator, a Celerity HP Chemical Indicator, and a layer of absorptive foam within a Tyvek pouch.

The intended change to the devices is to update the secondary container and product labeling. Specifically, the clear cellophane wrapper around the product carton will be replaced by a clear, laminated pouch. Labeling on the carton and the Instructions for Use (IFU) will be updated to specify that the product must remain stored in its original laminated pouch to maintain the claimed shelf-life. Additionally, a storage disclaimer label will be added to the exterior of the pouch to notify users of this change. Finally, this submission is intended to establish a 3-month in-use shelf-life following pouch opening, not to exceed the original expiration date.

Celerity 20 HP BI
The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, STERIS Celerity Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

Celerity 20 HP Challenge Pack
The Celerity 20 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator, a Celerity HP Chemical Indicator, and a layer of absorptive foam within a Tyvek pouch.

The intended change to these devices is to update the secondary container and product labeling. Specifically, the clear cellophane wrapper around the product carton will be replaced by a clear, laminated pouch. Labeling on the carton and the Instructions for Use (IFU) will be updated to specify that the product must remain stored in its original laminated pouch to maintain the claimed shelf-life. Additionally, a storage disclaimer label will be added to the exterior of the pouch to notify users of this change. Finally, this submission is intended to establish a 3-month in-use shelf-life following pouch opening, not to exceed the original expiration date.

The provided text describes premarket notification for biological indicators and doesn't involve an AI/ML powered medical device. Therefore, many of the requested criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study" or "number of experts used to establish ground truth", which are specific to AI/ML powered devices, are not applicable here.

However, I can extract information related to the acceptance criteria and the study proving the device meets those criteria, as much as applicable for a non-AI medical device.

Device: Celerity 5 HP Biological Indicator (LCB052) & Challenge Pack (LCB059), and Celerity 20 HP Biological Indicator (LCB044) & Challenge Pack (LCB045)

Type of Device: Sterilization Process Indicator (Biological Indicator - BI). These devices contain a specific type of spore (Geobacillus stearothermophilus) and media to confirm the effectiveness of a sterilization process. A positive result (fluorescent signal) indicates sterilization failure, while a negative result indicates successful sterilization.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and results are provided for two distinct product lines: Celerity 5 HP and Celerity 20 HP. Note that the "Result" for all tests is simply "PASS", indicating that the criteria were met.

For Celerity 5 HP Biological Indicator and Challenge Pack:

For Celerity 20 HP Biological Indicator and Challenge Pack:

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

The document does not explicitly state the numerical sample size (e.g., number of BIs or challenge packs) used for each specific test (Reduced Incubation Time, Simulated Use, Cap Media, Stability testing). It refers to "All BI lots" for Reduced Incubation Time and "All processed BIs" for Simulated Use, and implicitly "BIs" for Stability Testing. This suggests a statistically relevant number of units from manufactured lots were tested.

• Data Provenance: The document does not specify the country of origin of the data. Given the "U.S. Food & Drug Administration" letterhead and the manufacturer's address in Ohio, USA, it is highly likely that the testing was conducted in the US.
• Retrospective or Prospective: The testing appears to be prospective as it's a pre-market submission to demonstrate the device meets performance criteria for clearance. Stability testing also inherently involves prospective observation over time.

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

This concept is not applicable to this type of device. The "ground truth" for a biological indicator is determined by the biological and chemical reactions themselves (i.e., presence or absence of viable spores, or a color change in the chemical indicator), not by human expert interpretation of images or data. The determination of "sterile" or "non-sterile" from a biological indicator is a direct, objective measurement.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the results of biological indicators are typically objective and determined by the physical/chemical properties and reactions, not by subjective human interpretation requiring adjudication.

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

Not applicable. This is not an AI/ML device nor one that involves human "readers" interpreting medical images or data.

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

Not applicable. This is a physical, biological and chemical indicator device, not a software algorithm. The "Celerity Incubator" is an accessory that reads the fluorescent signal, it is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for these devices is based on biological viability (presence or absence of viable Geobacillus stearothermophilus spores) for the biological indicator and chemical reaction (color change) for the chemical indicator, validated against recognized sterilization parameters (e.g., D-value, Survival Time, Kill Time). This is a direct measure of the effectiveness of the sterilization process.

8. The Sample Size for the Training Set

Not applicable. These are not AI/ML devices that require training sets. The "training" of these devices (i.e., their manufacturing and design) is based on established microbiological and sterilization science.

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

Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The performance of these biological indicators relies on their inherent design and manufacturing quality, ensuring the spores exhibit the specified resistance characteristics and the media accurately detects their viability. This is established through rigorous quality control and adherence to relevant standards for biological indicators.

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Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.

The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI is incubated at 59° C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.

The provided text describes the Celerity Incubator, a Class II medical device, and its performance testing to demonstrate substantial equivalence to a predicate device. This device is designed to incubate and automatically read STERIS Celerity Biological Indicators for sterilization processes.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each test (e.g., how many biological indicators were tested for the Qualification Testing or how many barcodes were tested for recognition).

• Data Provenance: The document generally refers to "performance testing" conducted by STERIS Corporation for their 510(k) submission. It does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would typically be prospective, conducted under controlled laboratory conditions to demonstrate performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide details on the number of experts used or their qualifications for establishing ground truth, as the ground truth appears to be based on physical biological indicator growth ("7-day grow out") rather than expert review of complex images or data.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for the biological indicator test is the physical 7-day grow out, which is an objective measure, not a subjective interpretation requiring adjudication among experts.

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

Not applicable. The Celerity Incubator is a device that automates the reading of biological indicators, not an AI system assisting human readers with interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone Performance (Algorithm Only)

Yes, the testing described appears to be a standalone performance evaluation of the Celerity Incubator's ability to accurately read biological indicators, without human intervention in the reading process itself. The incubator performs the incubation and optical reading automatically.

7. Type of Ground Truth Used

The primary ground truth for the "Qualification Testing with intended Biological Indicators" is 7-day grow out of the biological indicators. This is an objective measure where biological indicators are incubated for a standard 7-day period to definitively determine if microbial growth occurred, which signifies a sterilization failure. The fluorescent reading from the Celerity Incubator is then compared against this established 7-day grow out result. For "Software Validation" and "Recognition of additional barcodes," the ground truth would be based on the intended functional specifications and correct barcode decoding, respectively.

8. Sample Size for the Training Set

Not applicable. This device is an automated incubator and reader, not an AI/ML device that requires a "training set" in the context of machine learning model development. Its function relies on established physical and optical principles for detecting fluorescence, not on learning from a large dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this device in the context of AI/ML.

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Celerity 5 HP Biological Indicator (LCB052), Celerity 5 HP Challenge Pack (LCB059), Celerity 20 HP Biological Indicator (LCB044), Celerity 20 HP Challenge Pack (LCB045)

Celerity 5 HP Biological Indicator

The Celerity 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX, maX, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems

· Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®

· Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterlizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.

Celerity 5 HP Challenge Pack

The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing. The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined chad is not included. The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 20 HP Biological Indicator

The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non-Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems.

· Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear

· Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear® When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes.

Celerity 20 HP Challenge Pack

The Celerity 20 HP Challenge Pack is intended for qualification testing of the V-PRO® Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined chaded. The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 5 HP BI

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, STERIS Celerity Incubator, within 5 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

Celerity 5 HP Challenge Pack

The Celerity 5 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator and a layer of absorptive foam within a Tyvek pouch.

Celerity 20 HP BI

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, STERIS Celerity Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

Celerity 20 HP Challenge Pack

The Celerity 20 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator and a layer of absorptive foam within a Tyvek pouch.

The provided document is a 510(k) summary for STERIS Corporation's Celerity 5 HP and Celerity 20 HP Biological Indicators and Challenge Packs. It details non-clinical tests conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study involving human readers or AI algorithms for diagnostic purposes.

Therefore, many of the requested criteria, such as "Sample size used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone (i.e. algorithm only without human-in-the-loop performance) was done," are not applicable to the information contained in this document. This document describes the performance of a physical medical device (Biological Indicator) intended to monitor sterilization cycles, not a software-based diagnostic tool or AI.

However, I can extract and present the relevant acceptance criteria and reported device performance from the provided tables.

Acceptance Criteria and Reported Device Performance

The document presents non-clinical performance testing for two sets of devices: Celerity 5 HP Biological Indicator/Challenge Pack and Celerity 20 HP Biological Indicator/Challenge Pack. The tables below combine the acceptance criteria and results for both, as they largely follow similar testing methodologies.

Celerity 5 HP Biological Indicator and Challenge Pack (Table 3)

Celerity 20 HP Biological Indicator and Challenge Pack (Table 6)

Study Details (Based on available information)

As noted, many elements of the request are not applicable as this document pertains to a physical biological indicator, not an AI or imaging diagnostic device.

1. Sample size used for the test set and the data provenance: The document uses terms like "All BI lots" and refers to testing of the biological indicators themselves rather than a "test set" of patient data. Specific sample sizes for each non-clinical test are not explicitly stated in this summary. The data provenance is from non-clinical laboratory testing performed by STERIS Corporation. There is no indication of country of origin of data or whether it was retrospective/prospective in a clinical sense.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for biological indicators in sterilization involves laboratory-based microbiology (e.g., presence or absence of spore growth in controlled environments), not expert human interpretation like radiologists for images.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a non-clinical device performance study, not a human reader study requiring adjudication.

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 is not an AI-assisted diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical biological indicator. The performance is assessed in a laboratory setting. The "Celerity Incubator" detects the fluorescent signal, but this is a device accessory, not an AI algorithm.

6. The type of ground truth used: The ground truth for the biological indicators is based on the viability of Geobacillus stearothermophilus spores, determined by their ability to grow and produce a fluorescent signal (or lack thereof) under specific, controlled laboratory conditions after exposure to sterilization processes. This is a direct microbiological assessment.

7. The sample size for the training set: Not applicable. This is a physical device that undergoes performance testing, not a machine learning model requiring a training set.

8. How the ground truth for the training set was established: Not applicable. As above, there is no "training set" in the context of this device.

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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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Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes:

· Gravity-displacement Steam Sterilization Cycles
132 °C, 25 minutes
132 °C, 15 minutes
132 °C, 10 minutes
135 °C, 10 minutes

· Dynamic-air-removal Steam Sterilization Cycles
132 °C, 4 minutes
135 °C, 3 minutes

Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) provides a defined challenge resistance against the claimed cycles shown below and demonstrated resistance equivalence to the ANSI/AAMI 16 towel pack. The device is intended for routine monitoring of the following steam sterilization processes:

· Gravity-displacement Steam Sterilization Cycles
132 °C, 25 minutes
132 °C, 15 minutes
132 °C, 10 minutes
135 °C, 10 minutes

· Dynamic-air-removal Steam Sterilization Cycles
132 °C. 4 minutes
135 °C. 3 minutes

Terragene® Bionova® Photon Auto-reader Incubator (BPH) incubates at 60°C and reads the Terragene® Bionova® Photon Biological Indicator (BT225) which is a 7-second readout Self-Contained Biological Indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores.

Bionova® Photon Process Challenge Devices consist of a disposable pre-assembled package as outlined in ANSI/AAMI ST79:2017 which contain a Bionova® Photon Biological Indicator (BT225), a Record Card and a chemical integrator that gives instant visible indication that sterilizing conditions have been reached. Each Bionova® Photon PCD consists of a stack of porous cards holding a Self-Contained Biological Indicator (SCBI) that contains a population of Geobacillus stearothermophilus ATCC®7953 spores on a carrier as well as growth indicator medium contained in a glass ampoule. Each SCBI has a process indicator on the label that changes from pink to brown when exposed to steam. These PCDs present a challenge to the sterilization process equivalent to the 16-towel process challenge device (PCD) recommended by the Associate for the Advancement of Medical Instrumentation (AAMI).

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes (number of devices or test runs) used for each performance study. It only mentions "Performance study" in the test descriptions.
The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. The studies are related to the performance of sterilization indicators and likely involve laboratory testing rather than human expert interpretation of results for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies involve objective physical and biological tests, not human interpretation that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. The device is a sterilization indicator, not a diagnostic imaging device that would typically involve human readers.

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

Yes, the studies described are standalone performance tests of the device (Process Challenge Device and its components) in various sterilization cycle conditions. The device's performance (e.g., color change of chemical integrator, fluorescence of biological indicator) is directly observed and compared to established standards or other devices.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

• Established standards: Specifically, ANSI/AAMI ST79:2017 (Comprehensive guide to steam sterilization and sterility assurance in health care facilities) for comparison against the 16-towel test pack.
• Known sterilization conditions: Labs would define "passing" and "failing" sterilization cycles for testing accuracy.
• Performance of predicate device: The predicate device (K191021) served as a benchmark for equivalent performance.
• Intrinsic BI and CI performance: The standalone biological and chemical indicators' known performance characteristics establish a baseline for comparison with the PCD.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical diagnostic tool (sterilization indicator), not an AI/ML algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this type of device.

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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.

Ask a specific question about this device

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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Terragene® Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with a minimum of 10º viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cvcles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

BT95 has rapid readout at 2 hours at 60 ℃ while BT96 has super rapid readout at 30 minutes at 60 ℃.

Terragene® Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met. Terragene® Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:

• · Sterrad® 100S Sterilization System.
• · Sterrad® 100NX Sterilization System (Standard and Express cycles).
• · V-Pro® maX Low Temperature Sterilization System (Non Lumen and Flexible cycles).
• · Sterizone® VP4 Sterilizer ( cycle 1 ).
• · LowTem Crystal 120 Sterilizer (Standard cycle).

The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.

Not Found

The provided text does not contain information about acceptance criteria for a medical device's performance (such as sensitivity, specificity, or accuracy) or details about a study designed to prove the device meets these criteria. The document is an FDA 510(k) clearance letter for sterilization process indicators, not a performance study report for a diagnostic or AI-powered device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, or details about training sets.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Details of a multi-reader, multi-case (MRMC) comparative effectiveness study or related effect sizes.
6. Standalone performance details.
7. Type of ground truth used.
8. How ground truth for the training set was established.

The document focuses on the regulatory clearance for biological and chemical indicators used to monitor sterilization processes, confirming their substantial equivalence to predicate devices, and outlining applicable regulations. It does not describe a clinical performance study as one would typically find for a diagnostic or AI device.

Ask a specific question about this device

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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