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The Kimberly-Clark™ Gas Plasma Indicator Strip is a chemical sterilization process indicator as defined in 21 CFR Part 880.2800(b). The indicator strip is intended to be used by a health care provider to accompany products being sterilized via a low temperature (STERRAD) sterilization process. The indicator strip is used to differentiate between product that has been exposed to hydrogen peroxide and product that has not been exposed to hydrogen peroxide. The strip will change color, from blue to green, upon exposure to the low temperature sterilant (hydrogen peroxide).

Device Description

The Kimberly-Clark Gas Plasma Indicator Strip (KCGPIS) is manufactured from a Tyvek® material or other synthetic substrate. The indicator is approximately 34 " wide by 4 inches long and is flexographically printed with a hydrogen peroxide sensitive ink.

AI/ML Overview

This document describes the validation of the Kimberly-Clark™ Gas Plasma Indicator Strip (KCGPIS).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds in the provided text, but rather implied by the description of the tests and successful outcomes. The device performance is reported as meeting these implied good manufacturing practice standards.

Acceptance Criteria (Implied)	Reported Device Performance
Aging Stability: Device function is not compromised by aging.	Aging (30 days @ 40° C/0% RH) did not affect the ability of the product to function as an indicator. Visual color comparisons confirmed no significant difference in color between control and aged samples.
Fading Resistance: Device maintains color integrity over time, especially under light exposure.	The KCGPIS exposed to fluorescent light over 12 days showed less fading than the predicate (STERRAD strip). KCGPIS maintained 80% color retention compared to 37.4% for the STERRAD strip.
Chemical Resistance (pH Buffer): Device is robust against various pH levels, especially acidic conditions.	While sensitive to alkaline materials (like the predicate), the KCGPIS provided better resistance to acidic materials than the STERRAD strip (7 of 33 color changing exposures for KCGPIS vs. 27 of 32 for STERRAD strip). Both were tested pre and post sterilization.
Specificity to EO/Steam Sterilization: Device does not inadvertently change color when exposed to common sterilization methods other than hydrogen peroxide.	Both KCGPIS and STERRAD strips maintained their pre-process colors when tested in EO (Ethylene Oxide) and steam sterilizers, validating the absence of color conversion by these alternative sterilization methods.
Indicator Efficacy: Device accurately and completely changes color upon exposure to a full STERRAD sterilization cycle.	Color change from blue to green was total as a result of a completed STERRAD sterilization cycle when contained in pouches and wrapped trays with medical instruments. KCGPIS adequately tracked exposure to hydrogen peroxide sterilant, and the color change was complete in all samples at the end of the diffusion cycle.

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

Sample Size for Test Set:
- Aging Study: Not explicitly stated, but implies a comparison between "control and aged samples."
- Fading Properties: Not explicitly stated, but implies multiple strips were tested to yield percentage retention.
- pH Buffer and Chemical Testing: 33 exposures for KCGPIS, 32 exposures for STERRAD strip.
- EO/Steam Sterilization: Not explicitly stated, but implies multiple strips were tested for each sterilization method.
- Indicator Efficacy: "All samples" showed complete color change when contained in pouches and wrapped trays, but the specific number of samples is not given.
Data Provenance: The document does not specify the country of origin of the data. The studies appear to be prospective in nature, as they involve testing the newly developed Kimberly-Clark™ Gas Plasma Indicator Strip under controlled conditions to demonstrate its performance.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The validation relies on observable color changes and comparisons to a predicate device, which implies a direct assessment without the need for expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set

The document does not mention any formal adjudication method (e.g., 2+1, 3+1). The nature of the device (a chemical indicator with a clear visual color change) suggests that adjudication by multiple independent parties would likely not be necessary. The assessment of color change is typically straightforward.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human interpretation plays a significant role, and the AI's impact on human reader performance is being evaluated. The KCGPIS is a simple chemical indicator with a direct visual output, not an AI-powered diagnostic tool.

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

Yes, the testing described is effectively a standalone performance evaluation of the chemical indicator itself. The device's performance is determined purely by its physical and chemical properties (color change in response to sterilant or other conditions), without any human interpretation element that an "algorithm" might typically assist or replace. There is no AI algorithm involved in this device.

7. The Type of Ground Truth Used

The ground truth used is primarily objective physical/chemical reaction.

For efficacy studies, the ground truth is whether the complete STERRAD sterilization cycle was actually performed (i.e., exposure to hydrogen peroxide sterilant). The indicator is then expected to change color.
For stability and resistance studies, the ground truth is the controlled environmental condition (e.g., specific temperature, humidity, light exposure, pH, or exposure to other sterilants like EO/steam). The expected behavior (no change or a specific change) is then observed.

8. The Sample Size for the Training Set

This question is not applicable. The KCGPIS is a chemical indicator, not an AI/machine learning device. Therefore, there is no "training set" in the context of an algorithm.

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

This question is not applicable, as there is no training set for an AI algorithm.

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