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Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the following sterilizers and cycles:

STERRAD 100® Sterilization System

STERRAD 100S® Sterilization System

STERRAD NX® Sterilization System (Standard and Advanced cycles)

STERRAD 100NX® Sterilization System (Standard, Flex, Express, and Duo cycles)

STERRAD NX® with ALLClear® Technology Sterilization System (Standard and Advanced cycles)

STERRAD 100NX® with ALLClear® Technology Sterilization System (Standard, Flex, Express, and Duo cycles)

V-PRO® 1 Low Temperature Sterilization System (Lumen cycle)

V-PRO® 1 Plus Low Temperature Sterilization System (Lumen and Non Lumen cycles)

V-PRO® maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)

V-PRO® 60 Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles)

V-PRO® maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles)

V-PRO® s2 Low Temperature Sterilization System (Lumen, Flexible, and Fast cycles) STERIZONE® VP4 Sterilizer (Cycle 1)

The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

Device Description

The 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 has an indicator ink bar printed on a white plastic strip. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide. 3M™ Comply™ Hydrogen Peroxide Indicator 1248 is a Type 1 (Category e1) Process Indicator as categorized by ISO 11140-1:2014.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the 3MTM Comply™ Hydrogen Peroxide Chemical Indicator 1248. This device is a chemical indicator, not an AI/ML powered medical device, therefore, many of the requested bullet points regarding AI/ML studies are not applicable.

Here's the information extracted from the document:

1. Table of acceptance criteria and the reported device performance

The document presents a summary of non-clinical testing, which includes acceptance criteria and results.

Test	Purpose	Acceptance Criteria	Result
STERIZONE® VP4 Sterilizer (Cycle 1) Color Development	To demonstrate the color change of the device and determine the minimum exposure time for end point color change when used in the STERIZONE® VP4 Sterilizer (Cycle 1)	Complete Cycle: Color change from blue toward pink.
7 second exposure: Color change is not as pink (bluer) than color reference match.
Determination of the minimum time for color to change from blue toward pink.	Pass
STERIZONE® VP4 Sterilizer (Cycle 1) End Point Color (Post-Sterilization) Light Stability	To demonstrate the end point color change stability of the device following exposure to STERIZONE® VP4 Sterilizer (Cycle 1)	No significant change in the endpoint color after exposure to light during storage.	Pass
ISO 11140-1:2014 Type 1 Absence of hydrogen peroxide	Verify device requires the presence of vaporized hydrogen peroxide to reach endpoint.	45 Min at 50°C: Device does not reach endpoint color.	Pass
ISO 11140-1:2014 Type 1 Hydrogen peroxide	Confirm device meets the Type 1 process indicator for vaporized hydrogen peroxide requirements.	7 Sec at 50°C and gas concentration of 2.3 mg/l: Device does not reach endpoint color.
6 Min at 50°C and gas concentration of 2.3 mg/l: Device reaches endpoint color.	Pass
ISO 11140-1:2014 Off-set/transference	Confirm device meets the Type 1 process indicator requirements.	After exposure to 6 Min at 50°C and gas concentration of 2.3 mg/l: Ink does not transfer to another surface.	Pass

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

The document specifies non-clinical testing was conducted to support the product performance. However, it does not explicitly state the specific sample size (e.g., number of indicators tested) for each test. The provenance of the data is implied to be from laboratory testing conducted by 3M, as indicated by "3M conducted nonclinical testing". The data would be prospective, directly generated from these tests. No country of origin for the data is specified beyond being conducted by 3M.

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

This is a chemical indicator, not an AI/ML-powered diagnostic device. Therefore, no human experts were used to establish "ground truth" in the way one would for diagnostic image interpretation. The ground truth for chemical indicators is established by objective physical and chemical changes in response to specific sterilization parameters and assessed against a predefined color reference.

4. Adjudication method for the test set

Not applicable. As this is a chemical indicator, there is no human adjudication process involved in interpreting results as there would be for an AI/ML diagnostic system. The results are based on objective chemical reactions and color 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

Not applicable. This is a chemical indicator, not an AI-assisted diagnostic device. No MRMC study was performed.

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

Not applicable. This is a chemical indicator. Its performance is inherent in its chemical reaction, not an algorithm.

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

The ground truth for this device is based on objective physical/chemical changes in the indicator ink (color change from blue toward pink) in response to specific controlled exposure conditions of vaporized hydrogen peroxide, as defined by sterilization standards (e.g., ISO 11140-1:2014) and verified by manufacturer testing. It's a binary outcome (reacted/not reacted, or sufficient/insufficient change) compared to a known reference.

8. The sample size for the training set

Not applicable. This is a chemical indicator, not an AI/ML device that requires a training set.

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

Not applicable. This is a chemical indicator, not an AI/ML device that requires a training set.

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