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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 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.

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