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Use the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 to secure packs and as an external pack process indicator to differentiate unprocessed items from items processed in the STERRAD® 100, 100S, NX® (Standard and Advanced cycles) and 100NX® (Standard, Flex, Express and Duo cycles) sterilization processes and AMSCO® V-PRO™ 1 (Lumen cycle), AMSCO® V-PRO™ 1 Plus (Lumen and Non Lumen cycles), and AMSCO® V-PRO™ maX Low Temperature Sterilization System (Lumen, Non Lumen, and Flexible cycles) sterilizers. The tape is suitable for use on non-woven disposable wraps and peel pouches. The chemical indicator stripes turn from blue to pink after exposure to vaporized hydrogen peroxide.

The 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 consists of a non-cellulosic plastic backing material with a pressure-sensitive adhesive on one side and chemical indicator stripes on the other side.

The provided document is a 510(k) Premarket Notification for the 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228. This document details the device's equivalence to a predicate device and provides information on non-clinical testing performed.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device, a chemical indicator tape, are primarily focused on its ability to change color reliably under specific sterilization conditions and the stability of that color change. The reported performance confirms that the device meets these criteria.

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

For the new AMSCO® V-PRO™ maX Low Temperature Sterilization System cycles (Lumen, Non Lumen, and Flexible cycles), the testing involved samples from six different lots of the device. The data provenance is not explicitly stated as retrospective or prospective, but it describes laboratory testing of new product lots, which implies prospective non-clinical testing. The country of origin of the data is not specified but is presumably where 3M conducts its research and development or contract testing.

For the previously cleared STERRAD cycles, the document references previous submissions (K020589 and K150694), implying the data for those cycles originated from prior non-clinical testing associated with those submissions.

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

The document does not mention human experts used to establish ground truth for color change. This is a chemical indicator, and its performance is determined by a quantifiable color change observed under specific conditions. The "ground truth" here is the chemical reaction itself and comparison to a predefined color specification for a "pass."

4. Adjudication Method for the Test Set

No adjudication method involving multiple human observers is mentioned, as the "ground truth" for the color change is based on a pre-defined color specification that the indicator must meet after exposure. The document states "in relation to the color match/specification," implying an objective chemical standard rather than subjective human interpretation needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or mentioned. This is a non-clinical device (chemical indicator) and its effectiveness is not assessed through human reader performance or diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

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

7. Type of Ground Truth Used

The ground truth used for this chemical indicator is an objective color specification or standard that the tape's chemical indicator stripes must meet after exposure to a specific sterilization cycle. For instance, the tape needs to turn from blue to pink, and the pink must fall within a defined color range to indicate a "pass." The document mentions "color match" and "color specification."

8. Sample Size for the Training Set

This concept is not applicable here as this is a non-clinical chemical indicator device, not an AI/ML algorithm. There is no "training set."

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

This is not applicable for the same reason as above.

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