Search Results

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.

Ask a specific question about this device

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

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

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

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

Ask a specific question about this device

Use the 3MM Attest™ Super Rapid Steam Biological Indicator 1592 in conjunction with the 3MM AttestTM Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor the following sterilization cycles:

Use the 3MM Attest™ Super Rapid Steam Challenge Pack 51582 in conjunction with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Autoreader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).

The 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 is a self-contained biological indicator (BI) specifically designed to be used with the 3M™ Attest™ Auto-reader 490 having software version 4.0.0 or greater or the 3MTM Attest™ Auto-reader 490H having software version 4.0.0 or greater to qualify or monitor dynamic-air-removal and gravity displacement steam sterilization cycles at 250°F (121°C).

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 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 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure.

The 3M™ Attest™ Super Rapid Steam Challenge Pack 51582 is specifically designed to qualify or monitor dynamic-air removal (pre-vacuum and SFPP) or gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C).

The 51582 Challenge Pack consists of multiple layers of medical index cards, some of which are die-cut to contain monitoring products. The pack is overwrapped and secured with a label. The Challenge Packs have the same design as the predicate device but contain different monitoring products. Each 51582 Challenge Pack contains a 3M™ Attest™ Super Rapid Steam Biological Indicator 1592 and a 3MTM 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. The 1592 BI is specifically designed for a rapid fluorescent result when used in conjunction with the 3M™ Attest™ Autoreader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater. The detection of fluorescence upon incubation of the 1592 in the 490 Auto-reader or the 490H Auto-reader (having software version 4.0.0 or greater) indicates a sterilization failure. 3M™ Attest™ 1592 BI controls are provided with the Challenge Packs. 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.

The 3M™ Attest Auto-reader 490 having software version 4.0.0 or greater or the 3M™ Attest™ Auto-reader 490H having software version 4.0.0 or greater are designed to incubate at 60°C and automatically read the 1592 BI for a fluorescent result within 24 minutes.

The provided text describes the acceptance criteria and study results for the 3M™ Attest™ Super Rapid Steam Biological Indicator 1592, the 3M™ Attest™ Super Rapid Steam Challenge Pack 51582, and associated 3M™ Attest™ Auto-Readers 490 and 490H.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents two main sets of non-clinical tests: one for the Biological Indicator (BI) and one for the Challenge Pack.

Biological Indicator (3M™ Attest™ Super Rapid Steam Biological Indicator 1592)

Challenge Pack (3M™ Attest™ Super Rapid Steam Challenge Pack 51582)

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

The document refers to "non-clinical testing" conducted in accordance with various FDA guidance documents and international standards (e.g., ISO, ANSI/AAMI, USP). This typically implies prospective, laboratory-based testing designed to verify performance against pre-defined specifications. The document does not specify the exact sample sizes (number of BIs or Challenge Packs tested) for each individual test or the country of origin of the data. However, the nature of these tests (e.g., D-value, population) usually involves specific, rigorous protocols with statistically sufficient sample sizes to ensure reliable results according to the referenced standards.

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)

The ground truth for these types of biological indicator and challenge pack studies is established through controlled laboratory experiments and adherence to international standards and regulations. It is not based on expert consensus in the typical sense of medical image interpretation (e.g., radiologists). The "ground truth" here refers to the actual performance of the biological indicators under precisely controlled sterilization or simulated sterilization conditions, measured by established microbiological methods (e.g., viable spore counts after exposure to steam, fluorescence detection by the auto-reader coupled with conventional incubation).

Therefore, there are no "experts" in the clinical interpretation sense. The "experts" involved would be microbiologists, engineers, and quality assurance personnel responsible for designing, executing, and analyzing these standardized tests. Their qualifications would stem from their adherence to the specified regulatory and standard requirements.

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

Not applicable. The tests are objective and based on measurable biophysical and microbiological parameters, not subjective assessments requiring adjudication. The outputs are "Passed" or "Failed" based on whether the device meets the pre-defined quantitative acceptance criteria.

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

Not applicable. This device is a sterilization process indicator (a biological and chemical indicator system coupled with an auto-reader), not an imaging or diagnostic device involving human interpretation or AI assistance for clinical decision-making. The "reader" here is an automated "Auto-reader 490/490H" and its performance is evaluated against objective microbiological standards, not against human readers.

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

Yes, in a sense, the performance of the device system (biological indicator + auto-reader) is evaluated in a standalone manner. The auto-reader automatically detects fluorescence, which indicates sterilization failure. The study validates the device's ability to accurately provide a "Passed" or "Failed" result based on its internal mechanism. The comparison is made against traditional microbiological methods (e.g., 7-day conventional incubation) to confirm the accuracy of the rapid fluorescent readout, confirming >97% alignment.

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

The ground truth is established through reference laboratory methods and adherence to standardized performance requirements. For example:

• Microbiological Counts: Determining the initial viable spore population (population test).
• Resistance Parameters (D-value, Z-value, Survival Time, Kill Time): Measured by exposing the biological indicators to precisely controlled steam sterilization conditions and then assessing spore viability using standard microbiological culture techniques. This is the gold standard for BI performance.
• Reduced Incubation Time Alignment: Comparing the rapid fluorescent readout result (e.g., 24 minutes) with the result obtained from conventional 7-day incubation (which is considered the definitive ground truth for spore viability). This involves culturing the BIs after exposure and determining growth/no growth.
• Simulated Use: Performance testing within mock sterilization loads/cycles to ensure the device performs as expected in representative conditions.

8. The sample size for the training set

Not applicable. This device is a physical/biological indicator system, not an AI/ML algorithm that requires a "training set" in the computational sense. The "training" of the system is the manufacturing and calibration processes to ensure it meets the design specifications and regulatory standards.

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

Not applicable, as there's no "training set" in the AI/ML context. The device's operational parameters and performance capabilities are based on its physical and biological design, as well as the manufacturing and testing processes that confirm its adherence to established standards for sterilization indicators.

Ask a specific question about this device

Use the 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382 to qualify or monitor:
· 121°C (250°F) 30-minute gravity steam sterilization cycles;
· 132°C (270°F) 4-minute dynamic-air-removal steam sterilization cycles.

The 3MTM Attest™ Rapid 5 Steam-Plus Test Pack 41382 is specifically designed to qualify and monitor 250°F (121°C) gravity and 270°F (132°C) dynamic-air-removal steam sterilization processes in healthcare facilities. The test pack consists of multiple layers of medical index cards, some of which are die-cut to contain the monitoring products. Each test pack has a process indicator on the pack label that changes from yellow to brown or darker when exposed to steam. This convenient disposable test pack presents a challenge to the sterilization process equivalent to the user-assembled biological indicator (BI) challenge test pack (16-towel PCD) recommended by the Association for the Advancement of Medical Instrumentation (AAMI). The test pack is a single use device.

Each test pack contains a 3M™ Attest™ Rapid Readout Biological Indicator 1292 (brown cap, hereinafter referred to as a 1292 BI), a 3M™ Attest™ Steam Chemical Integrator, and a record keeping sheet. AAMI recommends that steam sterilization loads containing an implant be monitored with a process challenge device (PCD) containing a biological indicator and an integrating indicator. 3MTM Attest™ Steam Chemical Integrators are Type 5 (Category i5) Integrating Indicators as categorized by ISO 11140-1:2014. 3M™ Attest™ Steam Chemical Integrators are single-use chemical indicators consisting of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. The chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a green window marked ACCEPT or a red window marked REJECT; the extent of migration depends on steam, time, and temperature. The 3MTM AttestTM Steam Chemical Integrator offers an immediate Accept/Reject reading that allows for implant load early release in emergency situations as defined in AAMI ST-79.

3M™ Attest™ Rapid Readout Biological Indicators 1292 comply with the requirements of ISO 11138-1:2017 and ISO 11138-3:2017. The 1292 BI is a dual readout biological indicator specifically designed for rapid and reliable monitoring of steam sterilization process when used in conjunction with the 3MTM Attest™ 290 Auto-reader or the 3M™ Attest™ Auto-reader 390. When steam processed, the process indicator on the 1292 BI label changes from rose to brown/black. Control 1292 BIs are provided with the test packs.

The 1292 BI detects the presence of Geobacillus stearothermophilus by detecting the activity of alpha-glucosidase, an enzyme present within the organism. The presence of the enzyme is detected by reading fluorescence produced by the enzymatic breakdown of a non-fluorescent substrate. This creates a fluorescence change, which is detected by the auto-reader. A fluorescence change indicates a steam sterilization process failure.

The 1292 BI can also indicate the presence of G. stearothermophilus organisms by a visual pH color change reaction. Biochemical activity of the G. stearothermophilus organism produces acid by-products that cause the media to change color from purple to yellow, which also indicates a steam sterilization process failure. Use of this indication method is optional and is typically restricted to special studies. Due to the high sensitivity of the 3-hour fluorescent results, however, there is no advantage to incubating the 1292 BI beyond 3 hours.

The provided text describes the 3M™ Attest™ Rapid 5 Steam-Plus Test Pack 41382 and its non-clinical testing to demonstrate substantial equivalence to a predicate device.

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 used for each test. It refers to "non-clinical tests" and "testing was conducted" without detailing the number of units tested. The data provenance is implied to be from 3M Company's internal testing facilities, as it's a submission for their device. The information indicates these are likely prospective laboratory studies, rather than retrospective human data.

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

This information is not provided. The testing described focuses on the physical and biological characteristics of a sterilization indicator, comparing it to established standards (AAMI, ISO, USP) and a predicate device. The determination of "ground truth" for these tests would likely involve adherence to standardized testing protocols and measurement techniques rather than expert consensus on a subjective result.

4. Adjudication Method:

This information is not provided. Given the nature of the tests (comparing resistance to established standards), the results (Pass/Fail) are likely determined directly by the adherence to and outcome of standardized protocols, rather than through an adjudication process involving multiple human reviewers.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices evaluated by human readers (e.g., imaging devices) where the impact of AI on human performance is assessed. The subject device is a biological/chemical indicator for sterilization, not an AI-powered diagnostic tool requiring human interpretation.

6. Standalone (Algorithm Only) Performance Study:

Yes, in essence, the non-clinical tests described represent a standalone performance evaluation of the device itself. The "algorithm" here is the physical and biological response of the indicator to sterilization conditions. The tests aim to demonstrate that the device, on its own, meets the specified resistance and performance criteria when exposed to controlled conditions.

7. Type of Ground Truth Used:

The ground truth used for the testing falls under established standards and objective measurements.

• For the "Comparison to AAMI 16 Towel PCD" test, the ground truth is the defined resistance characteristics of the AAMI ST79 16-Towel PCD.
• For the "Comparison to Biological Indicator" test, the ground truth is the inherent resistance of the Biological Indicator alone, as determined by standardized methods.
• More broadly, the acceptance criteria are based on recognized industry standards like ANSI/AAMI ST79, ISO 11138-1, ISO 11138-3, ISO 11140-1, and United States Pharmacopeia chapters.

8. Sample Size for the Training Set:

This information is not applicable and therefore not provided. The device is a physical sterilization indicator, not an AI or machine learning model that requires a "training set" in the conventional sense. Its performance is based on its physical and biological design and manufacturing consistency.

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. The device's fundamental function is based on established scientific principles of microorganism inactivation and chemical reactions under specific sterilization conditions, verified through empirical testing against standards.

Ask a specific question about this device