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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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The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray, or container to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:
250°F/121°C, 30 minutes Gravity
270°F/132°C, 10 minutes Dynamic Air Removal
270°F/132°C, 4 minutes Dynamic Air Removal
270°F/132°C, 15 minutes Gravity
273°F/134°C, 3 minutes Dynamic Air Removal
273°F/134°C, 4 minutes Dynamic Air Removal
275°F/135°C, 3 minutes Dynamic Air Removal
275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles Immediate Use Steam Sterilization (IUSS):
270°F/132°C, 4 minutes Dynamic Air Removal IUSS
270°F/132°C, 3 minutes Gravity IUSS
270°F/132°C, 10 minutes Gravity IUSS
275°F/135°C, 3 minutes Dynamic Air Removal IUSS
275°F/135°C, 3 minutes Gravity IUSS
275°F/135°C, 10 minutes Gravity IUSS

Stated values (as determined in a steam resistometer):

30 minutes at 121°C
9.1 minutes at 128°C
3.3 minutes at 132°C
2.4 minutes at 134°C
1.5 minutes at 135°C

The Getinge Assured MI Steam Migrating Integrator Strip is used in each pack to be sterilized to monitor exposure to critical process parameters of steam sterilization. The Getinge Assured MI meets the performance specifications for a Type 5 Integrating Indicator as defined by ANSI/AAMI/ISO 11140-1:2014.

It consists of a paper wick and a steam sensitive chemical pellet containing blue colored dye. A pellet is held within a pocket located at one end of an aluminum foil tape base. The foil tape base is adhered to a film material that has been bonded with a paper label. During steam sterilization, the Integrating Indicator pellet will melt and migrate into the PASS window when the specified critical parameters of steam sterilization have been met.

The information provided describes the acceptance criteria and study proving the Getinge Assured MI Steam Migrating Integrator meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The study involved "3 manufactured lots" of the Integrator for performance testing. The document does not specify the exact number of units or individual indicators tested within each lot for each distinct test. The data provenance is not explicitly stated as originating from a specific country, but the submission is to the U.S. FDA by a U.S.-based company (SteriTec Products Manufacturing CO INC, 74 Inverness Drive East Englewood, CO 80112 U.S.). The studies are prospective in nature, as they involve active testing of the device to verify performance.

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

This type of device (chemical integrator for sterilization) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The performance is based on physical and chemical reactions (e.g., color change, migration) under controlled conditions, compared against established standards. Therefore, information about the number or qualifications of human experts establishing ground truth for the test set is not applicable and not provided in the document.

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

Not applicable. The "ground truth" for chemical indicators like this is determined by objective physical/chemical changes against defined parameters (temperature, time, steam presence). It does not involve 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 device is a chemical indicator, not an AI-assisted diagnostic tool or system that involves human readers interpreting output.

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

Not applicable. This is a passive chemical indicator, not an algorithm or software. Its performance is inherent in its physical and chemical properties.

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

The ground truth for this device's performance is established by objective criteria based on physical and chemical reactions under controlled steam sterilization conditions, defined by international standards (ANSI/AAMI/ISO 11140-1:2014) and FDA guidance. This includes:

• Temperature and time exposure in a steam resistometer (BIER vessel).
• Observation of indicator agent migration/color change.
• Confirmation of lack of reaction under sub-lethal conditions (e.g., 15% less time, 1°C less, dry heat).
• Comparison with biological indicators in terms of inactivation.

8. The sample size for the training set:

Not applicable. This is a physical/chemical device, not a machine learning model, so there is no concept of a "training set" in the context of AI.

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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The 3M™ Attest™ Steam Chemical Integrators are designed to respond to all critical parameters over a specified range of steam sterilization cycles. The integrating indicator is intended to be placed in each pack, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer:

| 250°F/121°C
16.5 Minutes | 270°F/132°C
2.0 Minutes | 273°F/134°C
1.4 Minutes | 275°F/135°C
1.2 Minutes |
|-----------------------------|----------------------------|----------------------------|----------------------------|

3M™ Attest™ Steam Chemical Integrators are 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 window marked ACCEPT or window marked REJECT; the extent of migration depends on steam, time, and temperature.

Here's a breakdown of the acceptance criteria and the study information for the 3M™ Attest™ Steam Chemical Integrators, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that the testing was performed on the 3M™ Attest™ Steam Chemical Integrators, which are identical to previously cleared devices (K193254) and were tested using "identified test methodology". However, the specific sample sizes used for each test criterion in the current submission's test set are not explicitly mentioned.

The data provenance is implied to be from 3M Company's internal testing, as it's a submission for their device. The nature of the tests (resistometer, simulated use, dry heat, side-by-side with BI, color stability) suggests controlled laboratory and simulated clinical environments. It is a nonclinical study, likely prospective for the specific tests performed to demonstrate equivalence or performance.

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

This information is not provided in the document. The tests seem to rely on objective measures (e.g., time to reach endpoint, color change, resistometer readings) rather than subjective expert assessment of an outcome. For 'Endpoint Color Stability', the "endpoint decision must remain unchanged" implies a clear, objective visual criterion rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none). Given the tests are physical/chemical performance evaluations, it's likely they rely on objective measurements and established criteria, reducing the need for adjudication by multiple human observers.

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

No, a MRMC comparative effectiveness study was not done. This type of study typically involves human readers interpreting diagnostic images or data with and without AI assistance to measure improvement in diagnostic accuracy or efficiency. The 3M™ Attest™ Steam Chemical Integrators are physical/chemical sterilization process indicators, not an AI-powered diagnostic device, so such a study would not be applicable.

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

Yes, the studies reported are standalone performance evaluations of the device itself. The chemical integrators function independently to indicate sterilization parameters; there is no human "in-the-loop" once the integrator is placed in the sterilization cycle. The performance described (e.g., time to "ACCEPT" or "REJECT", endpoint not met in dry heat, correlation with BI) is inherent to the device's chemical and physical properties.

7. Type of Ground Truth Used

The ground truth for these tests is based on established physical and chemical principles and standards for sterilization.

• For SV (Stated Value) testing: It refers to a "stated test organism with stated D and z values," indicating a biological effectiveness standard. The ground truth for what constitutes a successful sterilization cycle (leading to an "ACCEPT" reading) is benchmarked against the known inactivation kinetics of biological indicators (BIs) and the physical parameters (time, temperature, steam) required for sterilization.
• For Health Care Facility Simulated Use Testing: The ground truth is "customer acceptable performance in cleared customer use sterilization cycles" and "failing conditions." This implies real-world or simulated real-world conditions where the outcome of sterilization (successful or failed) is known through other means (e.g., standard monitoring, biological indicators).
• For Dry Heat Testing: The ground truth is the absence of saturated steam, and the expected outcome for the device (not reaching endpoint).
• For Side-by-Side Testing with Biological Indicator: The ground truth is the performance of the biological indicator (BI), which is considered the gold standard for sterilization efficacy. The chemical integrator's performance is compared directly against the BI's inactivation.
• For Endpoint Color Stability: The ground truth is the initial "ACCEPT" or "REJECT" endpoint color, with the expectation that it should not change over time.

8. Sample Size for the Training Set

This question is not applicable as the 3M™ Attest™ Steam Chemical Integrators are not an AI or machine learning device that requires a training set. They are physical/chemical indicators.

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

This question is not applicable for the same reason as above.

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Use the 3MTM Attest™ Steam Chemical Integrator Test Pack 41360 to monitor:

• · 121°C (250°F) gravity displacement steam sterilization cycle at 30 minutes
• · 132°C (270°F) dynamic-air-removal steam sterilization cycle at 4 minutes
• · 135°C (275°F) dynamic-air-removal steam sterilization cycle at 3 minutes

3M™ Attest™ Steam Chemical Integrator Test Pack 41360 is specifically designed to routinely challenge the steam sterilization process in healthcare facilities. This convenient disposable process challenge device presents a challenge to the sterilization process equivalent to the 16towel process challenge device (PCD) recommended by the Associate for the Advancement of Medical Instrumentation (AAMI). Each test pack contains a process indicator on the outside that changes from yellow to brown or darker when steam processed.

Each pack contains a 3M™ Attest™ Steam Chemical Integrator and a record keeping sheet. The 3MTM Attest™ Steam Chemical Integrator consists of a paper wick and a steam and temperature sensitive chemical pellet contained in a paper/film/foil laminate. When exposed to steam sterilization conditions, the chemical pellet melts and migrates as a dark color along the paper wick. The migration is visible through a window marked REJECT or ACCEPT. The extent of migration depends on steam, time, and temperature.

The provided document describes the 3M™ Attest™ Steam Chemical Integrator Test Pack 41360. Based on the information, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

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 does not specify the exact sample size for the test set. It only states that "Performance testing to demonstrate substantial equivalence to the predicate device has been completed." The data provenance is not explicitly mentioned but is implied to be from 3M Company's internal testing as part of their premarket notification for the FDA. This would generally be considered prospective testing in a controlled laboratory environment.

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 is not applicable to the device described. The device is a chemical indicator for steam sterilization. Its performance is evaluated against established physical and chemical standards (like AAMI ST79) and other devices, rather than being assessed by human experts interpreting results.

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

This is not applicable. The performance testing involves objective measures of resistance to sterilization conditions, 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

This is not applicable. The device is a physical chemical indicator, not an AI or imaging diagnostic tool.

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

This is not applicable. The device is a physical chemical indicator. Its performance is inherent to its design and chemical properties.

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

The ground truth for the performance testing is based on established industry standards for steam sterilization and chemical indicators, specifically:

• ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
• ISO 11140-1:2014 Sterilization of health care products – Chemical indicators, Part 1: General Requirements

The ground truth for "resistance" is defined by these standards and the behavior of the AAMI 16 Towel Process Challenge Device (PCD) and a Biological Indicator.

8. The sample size for the training set

This is not applicable. The device is not an AI or machine learning model that requires a training set. The development of such physical indicators involves engineering, chemistry, and iterative testing, not "training" in the AI sense.

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

This is not applicable for the reasons stated above.

Ask a specific question about this device

The Getinge Assured MI Steam Migrating Integrator strip is an internal pack integrating indicator designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles: 250°F/121°C, 30 minutes Gravity 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 15 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS): 270°F/132°C, 4 minutes Dynamic Air Removal 270°F/132°C, 3 minutes Gravity 270°F/132°C, 10 minutes Gravity 275°F/135°C, 3 minutes Dynamic Air Removal 275°F/135°C, 3 minutes Gravity 275°F/135°C, 10 minutes Gravity

Stated values (as determined in a steam resistometer): 30 minutes at 121°C 9.1 minutes at 128°C 3.3 minutes at 132°C 1.5 minutes at 135°C

The Getinge Assured MI Steam Migrating Integrator is a single use device to monitor steam sterilization cycles. The integrating indicator is designed to react to critical process parameters of a steam sterilization cycle within a stated tolerance. The integrating indicator is intended to be placed in each pack, pouch, tray or container to function as an independent monitor of critical parameters for sterilization cycles. During steam sterilization, the integrating indicator pellet will migrate into the PASS zone when sterilization conditions have been met.

A paper wick and a steam sensitive chemical pellet containing blue colored dye. A pellet is held within a pocket located at one end of an aluminum foil base. The foil base is adhered to label material that has been bonded with a film. During steam sterilization, the integrating indicator pellet will migrate into the PASS zone when the specified critical parameters of steam sterilization have been met.

The provided text describes the Getinge Assured MI Steam Migrating Integrator, a chemical indicator used to monitor steam sterilization cycles. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• 30 Minutes at 121°C
• 3.3 minutes at 132°C
• 1.5 minutes at 135°C | PASS |
  | Steam Resistometer (BIER vessel) Testing (Pass/Fail at Reduced Time) | Failing Result at 15% less time of SV for each temperature claimed | PASS |
  | Steam Resistometer (BIER vessel) Testing (Pass/Fail at Reduced Temperature) | Failing Result at 1°C less for each temperature claimed | PASS |
  | Hospital Steam Sterilizer Testing | 100% samples passing under passing conditions for each cycle
  100% samples failing under failing conditions for each cycle | PASS |
  | Dry Heat Testing | Failing result when exposed to dry heat alone for 30 minutes (±1 minute) at 140°C (±2°C) | PASS |
  | Side-by-side testing of biological indicator and integrator in steam resistometer | The integrator does not reach its endpoint before the biological indicator is inactivated | PASS |
  | Offset/Transference | The indicator agent shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed | PASS |

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

The provided document does not specify the exact sample size for the test set (number of integrators used in each test). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.

However, for "Hospital Steam Sterilizer Testing," it mentions "an actual sterilization cycle used in a health care facility," which implies real-world, prospective testing. The resistometer testing would typically be conducted in a laboratory setting.

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

This information is not provided in the document. The ground truth for chemical indicators like this is typically established by the physical and chemical parameters of the sterilization cycle itself (achieving specific temperature, time, and steam conditions), and comparing the indicator's response to these measured parameters or to a biological indicator. There is no mention of human experts establishing ground truth in the context of interpreting the indicator's performance.

4. Adjudication Method for the Test Set

This information is not applicable or provided for this type of device. The determination of "PASS" or "FAIL" for the chemical integrator is based on the physical migration of the pellet into a "PASS" zone, which is a direct, observable, and objective outcome. There is no mention of human adjudication in interpreting the results of the performance tests.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or imaging analysis where human readers interpret output. The Getinge Assured MI Steam Migrating Integrator is a chemical indicator that provides a direct visual result (pellet migration to "PASS" zone), not an output that requires human interpretation in the same way as an imaging study. There is no AI component involved.

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

This question is not applicable as the device is a chemical indicator, not an algorithm. Its performance is inherent in its physical and chemical properties and its interaction with the sterilization parameters, not through an algorithm.

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

The ground truth used for testing the Getinge Assured MI Steam Migrating Integrator is based on:

• Physical and chemical parameters of the sterilization cycle: Measured temperature, time, and steam conditions in a controlled setting (steam resistometer).
• Comparison to a biological indicator (BI): For the side-by-side testing, the performance of the chemical integrator is compared against a biological indicator, which is considered the gold standard for verifying sterilization efficacy. The ground truth is that sterilization conditions must be sufficient to inactivate the biological indicator.

8. The sample size for the training set

This information is not applicable as there is no "training set" for a chemical indicator. Chemical indicators are designed and manufactured based on established chemical and physical principles, not through machine learning or algorithm training.

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

This information is not applicable as there is no training set.

Ask a specific question about this device

The 3M™ Attest™ Steam Chemical Integrators are designed to all critical parameters over a specified range of steam sterilization cycles. The integrating intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer: 250°F/ 121°C: 16.5 minutes 270°F / 132°C: 2.0 minutes 273°F / 134°C: 1.4 minutes 275°F / 135°C: 1.2 minutes

3M™ Attest™ Steam Chemical Integrators are 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 window marked ACCEPT or window marked REJECT; the extent of migration depends on steam, time, and temperature.

The provided text describes the acceptance criteria and the study that proves the 3M™ Attest™ Steam Chemical Integrators device meets these criteria.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the numerical sample size used for each test. It refers to "testing" and "samples" implying multiple units were tested per condition.
Data Provenance:

• Country of Origin: Not specified, but implied to be from the manufacturer (3M) based in the US (St. Paul, Minnesota).
• Retrospective or Prospective: Not explicitly stated, but the nature of the "Nonclinical Testing" and "Simulated Use Testing" suggests a prospective testing methodology where the device's performance is observed under controlled conditions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This device is a chemical indicator, and its performance is determined by a chemical reaction resulting in a visible color change, not by human interpretation or expert consensus in the way medical images are. The "ground truth" is defined by the physical and chemical parameters of the sterilization cycles (temperature, time, steam saturation) and the comparison to biological indicators.

4. Adjudication Method for the Test Set
Not applicable. As noted above, the endpoint is a direct physical change ("ACCEPT" or "REJECT" window) based on the chemical reaction, not a subjective interpretation requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done
No, an MRMC study was not done. This type of study is relevant for AI/radiology devices where human readers interpret medical images and the AI assists in that interpretation. This device is a chemical indicator for sterilization processes.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is typically asked for AI/software devices. For this chemical indicator, its "performance" is inherently "standalone" in that its chemical reaction and color change are intrinsic to the device and do not involve an "algorithm" or "human-in-the-loop" once exposed to the sterilization conditions. The results are observed/read by a human, but the indicator's performance itself is a direct chemical response.

7. The Type of Ground Truth Used
The ground truth for this device's performance is established by:

• Objective physical and chemical parameters: Specific temperatures and exposure times for steam sterilization cycles (e.g., 250°F/121°C for 30 minutes, 270°F/132°C for 3 minutes).
• Comparison to Biological Indicators (BI): The "Side-by-Side Testing with Biological Indicator" confirms that the chemical integrator's performance parallels that of a BI, which is the established standard for demonstrating sterility.
• Controlled resistometer testing: A resistometer provides precisely controlled and verifiable steam, time, and temperature conditions.

8. The Sample Size for the Training Set
Not applicable. This device is a passive chemical indicator, not an AI/machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a chemical indicator.

Ask a specific question about this device

The 3M™ Attest™ Steam Chemical Integrators are designed to all critical parameters over a specified range of steam sterilization cycles. The integrating intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Minimum Stated Values for 3M™ Attest™ Steam Chemical Integrators as determined in a resistometer: 250°F / 121°C: 16.5 minutes 270°F/ 132°C: 2.0 minutes 273°F/ 134°C: 1.4 minutes 275°F/ 135°C: 1.2 minutes

3M™ Attest™ Steam Chemical Integrators are 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 window marked ACCEPT or window marked REJECT; the extent of migration depends on steam, time, and temperature.

The provided text describes the acceptance criteria and study proving the device meets those criteria, specifically for the 3M™ Attest™ Steam Chemical Integrators (K191236).

Here's the breakdown of the information requested:

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

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

The document does not specify the exact sample sizes (number of integrators) used for each test. However, it indicates that the testing was conducted in accordance with "FDA Guidance for Industry and FDA Staff: Premarket Notification [510(k)] Submissions for Chemical Indicators, issued December 19, 2003 as well as ANSI/AAM/ISO 11140-1:2014." These standards would define the appropriate sample sizes for such tests.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that this is a 510(k) submission to the US FDA, it can be inferred that the studies were conducted by or on behalf of 3M Company, located in St. Paul, Minnesota, USA. The nature of the tests ("Nonclinical testing") suggests prospective laboratory-based studies rather than retrospective clinical data.

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 and therefore not provided in the document. The device is a chemical indicator for sterilization processes. Its "ground truth" (i.e., whether sterilization conditions were met or not, or if it indicates "ACCEPT" or "REJECT") is determined by objective physical and chemical reactions under controlled laboratory conditions using resistometers and simulated use cycles, not by expert human interpretation like in medical imaging. The performance is assessed against established physical parameters and the performance of biological indicators, not human expert consensus.

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

Not applicable. As explained in point 3, the output of the chemical indicator is an objective visual change (migration of a dark color to an ACCEPT or REJECT window). There is no human interpretation or adjudication process described for determining the device's output.

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 passive chemical indicator, not an AI-assisted diagnostic tool that would involve human readers. Therefore, an MRMC study and AI assistance are irrelevant to its evaluation.

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

This refers to the core performance of the device itself. The "Nonclinical Testing" summarized in the document is essentially the standalone performance evaluation of the chemical indicator. The device (chemical indicator) intrinsically operates "standalone" as a physical/chemical system without human intervention or an algorithm in the traditional sense of medical devices. Its performance is directly observed and measured against physical parameters of sterilization cycles.

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

The "ground truth" for the performance of the 3M™ Attest™ Steam Chemical Integrators is established through:

• Physical Parameters: Measured steam temperature and exposure time in controlled resistometers.
• Biological Indicator Inactivation: The performance is correlated and compared to biological indicators (BIs), which contain resistant bacterial spores, serving as a gold standard for sterilization effectiveness. The acceptance criteria state "Chemical integrator parallels performance of BI and does not reach endpoint before BI is inactivated."
• Defined Pass/Fail Conditions: Precise conditions (e.g., minimum stated values, exposure to failing conditions) are set for evaluation.

8. The sample size for the training set

Not applicable. This device is a chemical indicator, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data-driven model development. The device's performance is based on its inherent chemical and physical properties and manufacturing consistency, not on learned data.

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

Not applicable, as there is no training set for this device type.

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SteriTec Biological Test Pack with Instant Readout Integrator is a single-use device designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The provided text describes a 510(k) premarket notification for a medical device called the "SteriTec Biological Test Pack with Instant Readout Integrator, Model No.: B1 111." This device is a biological indicator designed for testing pre-vacuum steam sterilizers.

However, the document is a regulatory clearance letter, not a scientific study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, the detailed information requested regarding acceptance criteria, device performance, study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies (MRMC) is not available within this document. This letter does not provide the results of any clinical or performance studies.

To answer your questions comprehensively, information from the actual device validation study would be needed, which is not included in this FDA 510(k) clearance letter.

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SteriTec Smart Read Biological Test Pack with Instant Readout Integrator is a single-use device designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The test pack consists of a selfcontained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The provided text is a 510(k) clearance letter from the FDA for the SteriTec Smart-Read Biological Test Pack. It does not contain information about the acceptance criteria, device performance, or details of a study that proves the device meets acceptance criteria in the context of an AI/ML medical device.

The document discusses:

• The device name and model number.
• The regulation number and name.
• The regulatory class.
• The product code.
• The date of the submission and receipt.
• The determination of substantial equivalence to a legally marketed predicate device.
• General controls provisions of the Act that apply to the device.
• Contact information for various FDA divisions.
• The intended indications for use of the device, which is a biological test pack for steam sterilizers.

This biological test pack is a physical device used to verify sterilization conditions, not an AI/ML algorithm or software. Therefore, the requested information regarding AI/ML device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, or ground truth establishment relevant to AI/ML devices is not present in this document.

Ask a specific question about this device

SteriTec Smart Read Biological Test Pack with Instant Readout Integrator is designed specifically for testing of 3 or 4 minutes at 132°C (270°F) and 3 minutes at 135°C (275°F) in pre-vacuum steam sterilizers. When used as directed, the Chemical Indicator Record Card gives visible indication that sterilizing conditions were met.

The test pack consists of a self-contained biological indicator containing Geobacillus stearothermophilus inside a small package of porous and nonporous materials, simulating the biological indicator 16 towel test packs defined by AAMI ST79.

This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about specific acceptance criteria or the study used to prove the device met those criteria. The letter acknowledges the submission and declares the device substantially equivalent to a predicate device based on the information provided by the applicant.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device