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The VERIFY® HPU Chemical Indicator 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 to indicate, through a visible change from magenta to yellow, when the device has been exposed to the Lumen, Non Lumen, Flexible or Fast Non Lumen sterilization cycle of a V-PRO® Low Temperature Sterilization System.

The VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 vaporized hydrogen peroxide sterilization process indicator. It is designed to distinguish between processed and unprocessed units, when affixed to packs to be sterilized, through a visible color change from magenta to yellow, when the pack has been exposed to the Lumen, Non Lumen, Flexible or Fast Non Lumen sterilization cycle of a V-PRO® Low Temperature Sterilization System.

The VERIFY® V-PRO Chemical Indicator is used in each processing cycle to indicate exposure to a Lumen, Non Lumen, Flexible, or Fast Non Lumen Cycle in a V-PRO 1, V-PRO 1 Plus, V-PRO maX, V-PRO 60, or V-PRO maX 2 Low Temperature Sterilizer. When exposed to the defined processing conditions, the indicator exhibits a visible color change from magenta to yellow.

The VERIFY® V-PRO Chemical Indicator is provided as two formats:

• Version 1C: VERIFY® HPU Chemical Indicator
• Version 2C: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label
  (Collectively referenced as the VERIFY® V-PRO Chemical Indicator)

The Version 1C: VERIFY® HPU Chemical Indicator is a Type 1 process indicator in accordance with ISO 11140-1:2014 which consists of the chemical indicator applied to a spun bonded polyolefin substrate.

The Version 2C: VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label is a Type 1 process indicator in accordance with ISO 11140-1:2014 which consists of the chemical indicator applied to a spun bonded polyolefin substrate with an adhesive supplied on a backing paper.

The STERIS VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label are Type 1 vaporized hydrogen peroxide sterilization process indicators designed to distinguish between processed and unprocessed units through a visible color change from magenta to yellow.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Test of 6 Lots" for the Type 1 Performance Testing, indicating that 6 production lots of the chemical indicators were used for testing. However, the specific number of individual indicators or test units per lot is not provided.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. However, given that Albert Browne Ltd., a subsidiary of STERIS Corporation, is located in the United Kingdom and is involved in manufacturing, it is likely that parts of the testing or data generation might have occurred there or in other STERIS facilities.

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

This information is not provided in the document. As this is a chemical indicator with a visible color change, the "ground truth" for whether the indicator passed or failed is likely based on the color change as per the device specification, rather than expert interpretation of complex data.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of a chemical indicator (visible color change), the adjudication method might involve simple visual inspection against a reference, which may not explicitly require a complex adjudication process like 2+1 or 3+1.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is evaluated. For a chemical indicator, the primary function is a direct color change, not an interpretive task for human readers that would be improved by AI assistance. The document confirms that the device is a "standalone" indicator.

6. Standalone Performance

Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The performance testing described in "Table 5-2. Verification Results Summary" directly assesses the chemical indicator's ability to change color in the specified sterilization cycles without human interaction influencing the indicator's performance. The "Study Result" column, showing 100% Pass, represents the standalone performance of the chemical indicators.

7. Type of Ground Truth Used

The ground truth used is the expected visible color change from magenta to yellow after exposure to specific sterilization conditions. This is an objective chemical reaction, not based on expert consensus, pathology, or outcomes data. The acceptance criteria specify that the indicator should "Pass" if it exhibits this color change to a certain percentage (e.g., $\geq$ 90%).

8. Sample Size for the Training Set

This information is not provided in the document. Chemical indicators usually don't involve a machine learning model that requires a "training set" in the traditional sense. Their performance is based on the chemical formulation and manufacturing consistency, which are validated through performance testing rather than training data.

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

Since there is no mention of a training set or machine learning model, the concept of establishing ground truth for a training set is not applicable here. The device's performance is driven by its material composition and chemical reaction, which are verified through the outlined performance tests.

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