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The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
· Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including those systems with ALLClear Technology.

A version of the Celerity™ HP Chemical Indicator (CI) may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:
· Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD® System, including STERRAD NX and 100NX with ALLClear Technology.

The Celerity™ HP Chemical Indicator (CI) is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when placed within packs to be sterilized, through a visible change from red to orange/yellow, when the device has been exposed to the:

• . Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology.

A version of the Celerity™ HP Chemical Indicator may be utilized on the V24 Self-Contained Biological Indicator Vial Label and is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed SCBIs, whilst affixed to SCBI vials to be sterilized, through a visible change from red to orange/yellow, when the SCBI has been exposed to the:

• Lumen, Non Lumen, Flexible, Fast Non Lumen or Fast sterilization cycle . of a V-PRO® Low Temperature Sterilization System, or
• Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP ● STERRAD® System, including those systems with ALLClear Technology

The CI is composed of the following components:

• Substrate ●
• Indicator Ink

The PI is composed of the following components

• Substrate
• Indicator Ink
• Adhesive ●
• Backing Paper

This document describes the Celerity™ HP Chemical Indicator (CI), a Type 1 vaporized hydrogen peroxide sterilization process indicator. The device is designed to distinguish between processed and unprocessed units through a visible color change from red to orange/yellow when exposed to specific sterilization cycles of V-PRO® Low Temperature Sterilization Systems and ASP® STERRAD® Systems.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). However, it implies that the testing was conducted by STERIS Corporation or its subsidiary Albert Browne Ltd., located in the United Kingdom. Given the nature of chemical indicator testing, it is likely that the testing involved multiple samples for each stress/condition investigated. The studies are non-clinical performance data, implying these were laboratory-based experiments.

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

This information is not applicable to a chemical indicator device. The "ground truth" for chemical indicators is based on whether the indicator changes color in response to specific sterilization parameters (e.g., presence of hydrogen peroxide) and according to established international standards (ANSI/AAMI/ISO 11140-1:2014). This is a physical or chemical reaction, not a subjective interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The color change of a chemical indicator is a direct, observable outcome, not subject to human adjudication in the same way as, for example, image interpretation. The "adjudication" is essentially a pass/fail determination based on the observable color change as per the device's design and specified standards.

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 devices that rely on human interpretation, such as imaging AI algorithms, to assess the impact of the device on reader performance. Chemical indicators do not involve human interpretation in this manner.

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

Yes, the studies described are standalone performance tests of the chemical indicator itself. The device is a "Type 1 process indicator," meaning it provides a visual confirmation of exposure to the sterilization process. Its function is entirely automated in terms of its chemical reaction to sterilization conditions; there is no "human-in-the-loop" performance aspect in the mechanism of the indicator itself. Its performance is assessed purely on its ability to change color accurately under specified conditions.

7. The Type of Ground Truth Used

The ground truth used for this chemical indicator's performance evaluation is based on controlled exposure to validated sterilization cycles and conformance to established international standards (ANSI/AAMI/ISO 11140-1:2014). The expected color change (red to orange/yellow) when exposed to these conditions, and the lack of change when not exposed, constitutes the ground truth.

8. The Sample Size for the Training Set

No training set is mentioned or applicable. Chemical indicators operate based on chemical reactions; they do not involve machine learning algorithms that require training data.

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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