Search Results

Use the 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 as an internal pack process indicator to verify exposure to vaporized hydrogen peroxide in the STERRAD® 100S, STERRAD® NX (Standard and Advanced cycles), STERRAD® 100NX (Standard, Flex , Express and Duo cycles), STERRAD® NX with ALLClear™ Technology (Standard and Advanced cycles), STERRAD® 100NX with ALLClear™ Technology (Standard, Flex , Express and Duo cycles), AMSCO® V PRO® 1 (Lumen cycle), AMSCO® V PRO® 1 Plus (Lumen and Non Lumen cycles), AMSCO® V PRO® maX Low Temperature Sterilization System (Lumen , Non Lumen, and Flexible cycles), AMSCO® V-PRO® 60 Low Temperature Sterilization System (Lumen , Flexible cycles), and AMSCO® V-PROTM maX 2 Low Temperature Sterilization System (Lumen, Flexible, and Fast Non Lumen cycles) sterilizers. The chemical indicator bar turns from blue toward pink after exposure to vaporized hydrogen peroxide.

The 3M™ ComplyTM Hydrogen Peroxide Chemical Indicator 1248 consists of a noncellulosic plastic material onto which a chemical indicator bar is printed. A comparison color match is also printed on the product to aid in color interpretation.

Here's a breakdown of the requested information based on the provided document:

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 sample size for the test set or the data provenance (country of origin, retrospective/prospective). It generally refers to "nonclinical testing" performed in specific sterilizers and cycles.

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 device's performance (color change) is an objective, physical characteristic, not requiring expert interpretation for ground truth.

4. Adjudication method for the test set

This information is not applicable as the device's performance is determined by an objective color change, not subjective evaluation requiring adjudication among experts.

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 chemical indicator, not an AI-powered diagnostic tool, and therefore no human reader studies with or without AI assistance were conducted or would be relevant.

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, not an algorithm. Its performance is inherent to its material properties and chemical reaction.

7. The type of ground truth used

The ground truth for the performance of the chemical indicator is the objective chemical reaction leading to a color change from blue toward pink upon exposure to vaporized hydrogen peroxide. For the "End Point Color Stability" test, the ground truth is the absence of significant color change after a specified period. These are physical/chemical observations rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. The device is a physical chemical indicator, not a machine learning model, so there is no training set in the context of AI.

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

This is not applicable, as there is no training set for a chemical indicator. The performance characteristics are based on established chemical principles and empirically determined through laboratory testing.

Ask a specific question about this device