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AN85/AN86 EO Indicators are single-use Type 1 process indicators used to distinguish between processed packaged medical devices, through a visible color change from yellow-green to blue. They are intended for the 12 hour sterilization cycle at 20-29°C in the Anprolene AN75 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 1.

AN85/AN86 EO Indicators are adhesive-backed Type 1 process indicators for ethylene oxide sterilization that conform to AAMI/ANSI/ISO 11140-1.

AN85/AN86 EO Indicators contain a pH indicator. The pH indicator ink is printed in dots on the AN85 and in stripes on the AN86. The indicator ink is laminated between two layers of plastic material and changes color from yellow-green to blue by chemical reactions when exposed to ethylene oxide.

The provided document describes the acceptance criteria and a study demonstrating that the AN85/AN86 EO Indicators meet these criteria.

Here's the breakdown:

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 a distinct "test set" sample size in terms of number of actual indicators used. The testing was described as "Performance testing" characterized in a Chemical Indicator Evaluator Resistometer (CIER) and an Anprolene AN75 Ethylene Oxide Gas Sterilizer.

• Sample size: Not explicitly quantified. The document states "AN85/AN86 EO Indicators" or "subject AN85/AN86 EO Indicators" were tested, implying a sufficient number for the experiments, but a specific count is not given.
• Data provenance: Prospective. The performance testing was conducted specifically to demonstrate the safety and effectiveness of the AN85/AN86 EO Indicators for their intended use with the Anprolene AN75 Ethylene Oxide Gas Sterilizer.

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

Not applicable. This device is a chemical indicator, not a diagnostic device requiring human expert interpretation in the traditional sense for establishing ground truth. The "ground truth" for its performance is determined by its chemical reaction to ethylene oxide under controlled conditions, producing a visible color change.

4. Adjudication method for the test set

Not applicable. As noted above, the performance of a chemical indicator is based on its visible color change response to chemical exposure, rather than a subjective interpretation requiring adjudication. The "Pass" results in the summary table indicate that the indicators successfully met the predefined chemical and physical criteria for each test.

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 a chemical indicator, not an AI-powered diagnostic device. No human reader studies (MRMC or otherwise) were conducted or are relevant.

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

Not applicable. This is a chemical indicator; there is no algorithm involved. The "standalone" performance means the indicator itself (the physical device) was tested.

7. The type of ground truth used

The ground truth for the AN85/AN86 EO Indicators is based on:

• Controlled chemical and physical exposure: The indicators are exposed to precisely defined ethylene oxide sterilization cycle parameters (temperature, time, gas concentration, humidity) in a Chemical Indicator Evaluator Resistometer (CIER) and the Anprolene AN75 Ethylene Oxide Gas Sterilizer.
• Observable color change: The ground truth is the predictable and consistent color change from "yellow-green to blue" when exposed to these parameters, and no color change when not exposed.
• Compliance with standards: Adherence to ISO 11140-1 for Type 1 process indicators.

8. The sample size for the training set

Not applicable. This is a chemical indicator, not a machine learning model that requires a training set.

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

Not applicable. This is a chemical indicator, not a machine learning model.

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The AN85/AN86 EO Indicators are single-use Class 1 process indicators used to distinguish between processed and unprocessed packaged medical devices, through a visible color change from yellow-green to blue. They are intended for the 3 hour sterilization cycle at 50°C in the EOGas 4 Ethylene Oxide Gas Sterilizer manufactured by Andersen Sterilizers, Inc. Critical process parameters for the cycle are summarized in Table 5-1.

AN85/AN86 EO Indicators are adhesive-backed Class 1 process indicators for ethylene oxide sterilization that conform to AAMI/ANSI/ISO 11140-1.

AN85/AN86 EO Indicators contain a pH indicator. The pH indicator ink is printed in dots on the AN85 and in stripes on the AN86. The indicator ink is laminated between two layers of plastic material and changes color from yellow-green to blue by chemical reactions when exposed to ethylene oxide.

Here's an analysis of the provided text regarding the AN85/AN86 EO Indicators, focusing on the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the "Functionality" test in Table 5-2, which refers to ISO 11140-1 Class 1 process indicator standards and the device's ability to indicate EO exposure under specific conditions. The reported performance is a simple "Pass" for all criteria.

Study Details:

The information provided only describes "Performance Testing" which consists of "bench studies." There is no detailed study protocol, raw data, or statistical analysis provided in this summary.

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

• Sample Size for Test Set: The document doesn't explicitly state the sample size (number of indicators) used for each test. It mentions "bench studies" and that the "AN85/AN86 EO Indicators perform as intended," but no specific counts are given for the number of devices tested in the CIER or EOGas 4 sterilizer.
• Data Provenance: The studies were conducted by Andersen Sterilizers, Inc., the manufacturer. They are described as "bench studies," implying prospective testing. The country of origin for the data is not explicitly stated but implied to be the US given the manufacturer's address and FDA submission.

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

This type of device (chemical indicator) does not involve expert interpretation for ground truth. The "ground truth" is based on objective chemical reactions and physical changes (color change) when exposed to specific sterilization conditions. The assessment of whether the color change occurred and meets the Class 1 indicator definition is likely done by trained laboratory personnel following an established protocol, not by medical experts like radiologists.

4. Adjudication Method for the Test Set

Not applicable for this type of device. The assessment is objective (color change from yellow-green to blue) and does not involve subjective interpretation or multi-reader adjudication.

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

No. An MRMC study is not relevant for this type of device. This device is a chemical indicator that shows a visible color change, not an interpretive diagnostic tool requiring human reader assessment or comparison with AI.

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

Yes, in a way. The device itself (the chemical indicator) performs as a standalone tool that changes color. There is no "algorithm" in the digital sense, but the chemical reaction within the indicator operates independently to display the result. Its performance is assessed directly (i.e., whether it correctly changes color under specified conditions and remains unchanged under others).

7. The Type of Ground Truth Used

The ground truth is established by the known exposure conditions to ethylene oxide within controlled environments (CIER and EOGas 4 sterilizer) and the expected chemical reaction/physical change (color change from yellow-green to blue) as defined by ISO 11140-1 for Class 1 process indicators. Essentially, it's a physical/chemical ground truth based on controlled experimental conditions.

8. The Sample Size for the Training Set

Not applicable. This device is a chemical indicator, not a machine learning or AI model that requires a training set. Its performance is based on its inherent chemical and physical properties.

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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