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The Verify® Challenge Packs -Version 2 - are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam sterilization. The Verify® Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The challenge pack models and their cycle temperatures, types, and times are:

There is a process indicator outside of the packs which undergoes a visual color change when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).

The proposed Verify® Challenge Packs – Version 2 -consist of an emulating indicator surrounded by a steam penetration barrier. The indicator ink inside the proposed Verify® Challenge Packs changes from yellow to blue/purple color when the steam sterilization cycle is complete:

• The Verify® 270F 4 Challenge Pack -Version 2 can be used to monitor a 4 . minute 270ºF/132ºC Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle.
• The Verify® 275F 3 Challenge Pack -- Version 2 can be used to monitor a 3 . minute 275°F/135°C pre-vacuum steam sterilization cycle.
  The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).

This document describes the acceptance criteria and performance of the Verify® Challenge Pack – Version 2. This device is a chemical indicator used to monitor steam sterilization cycles.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on the color change of the indicator within the pack and an external process indicator. The key performance criteria are related to the appropriate color change after exposure to specific sterilization cycles.

• Verify® 270F 4 Challenge Pack: 4 minute 270ºF/132ºC Steam-Flush Pressure-Pulse (SFPP) and pre-vacuum steam sterilization cycle.
• Verify® 275F 3 Challenge Pack: 3 minute 275°F/135°C pre-vacuum steam sterilization cycle. | The performance of the Verify® Challenge Packs -- Version 2 - meets the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] steam indicators.
  "The indicator sheet within the challenge pack changes color from yellow to blue/purple when exposed to the proper time and temperature of the designated steam sterilization cycle."
  Specific performance for each model:
• Verify® 270F 4: Indication of successful monitoring for 4 minute 270°F (132°C) Pre-vacuum, Steam Flush Pressure Pulse (SFPP) cycle.
• Verify® 275F 3: Indication of successful monitoring for 3 minute 275°F (135°C) Pre-vacuum cycle. |
  | External Process Indicator Performance | The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C). | "The process indicator outside of the packs undergoes a visual color change from pink to dark purple when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C)."
  "Performance testing was conducted to verify that the process indicator on the outside of the challenge packs change color from pink to dark purple when exposed to the following full steam sterilization cycles:
• 4 minute 270°F/132°C dynamic air removal steam sterilization cycle.
• 3 minute 275°F/135°C dynamic air removal steam sterilization cycle." |

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

The document mentions "Performance testing was conducted," but does not specify the sample size for the test sets (i.e., how many challenge packs were tested for each cycle type). The data provenance is not explicitly stated in terms of country of origin, but it is from STERIS Corporation in Mentor, OH, USA, and the submission is to the FDA. The testing conducted appears to be prospective as it's part of verification and validation activities for a new version of a device.

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

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set. For chemical indicators, ground truth is typically based on physical-chemical responses to controlled sterilization parameters rather than expert interpretation of complex images or data. The "ground truth" here is the known successful completion of the sterilization cycle, confirmed by cycle parameters, and the subsequent expected color change of the indicator.

4. Adjudication Method for the Test Set:

Given that the performance is based on an objective color change (yellow to blue/purple, pink to dark purple) in response to a sterilization cycle, an adjudication method in the traditional sense (e.g., 2+1, 3+1) is not applicable or mentioned. The assessment of color change is typically a direct observation against defined color standards or by trained personnel understanding the intended change.

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 or mentioned. This type of study is relevant for diagnostic devices where human interpretation of results is variable and the AI's effect on human performance is being evaluated. For a simple chemical indicator with a clear visual output, such a study would not be appropriate.

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

Yes, the performance testing described is essentially a "standalone" assessment of the device. The device itself is a chemical indicator that autonomously changes color based on exposure to sterilization conditions. Its performance is evaluated based on its physical response (color change) to defined sterilization cycles, without human intervention affecting the "reading" of the indicator other than visual confirmation of the color change. There's no "algorithm" in the context of AI; the device's function is purely chemical and physical.

7. The Type of Ground Truth Used:

The ground truth used is based on controlled sterilization cycle parameters and the physical-chemical response of the indicator. Specifically:
* Known exposure to full steam sterilization cycles: 4 minute 270°F/132°C dynamic air removal steam sterilization cycle (SFPP and prevacuum) and 3 minute 275°F/135°C dynamic air removal steam sterilization cycle (prevacuum).
* Adherence to recognized standards: The internal indicator's performance is stated to meet the requirements of ANSI/AAMI / ISO 11140-1:2005 for emulating [Class 6] steam indicators, which sets industry standards for chemical indicator performance.

8. The Sample Size for the Training Set:

This information is not provided in the document. As this device is a physical chemical indicator, there isn't a "training set" in the context of machine learning. The term "training set" is generally used for AI/ML algorithms where data is used to teach a model. For a chemical indicator, the development process involves chemical formulation and design testing, rather than data-driven training.

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

Since there is no "training set" in the AI/ML sense, this question is not applicable. The underlying chemical properties and reactions for the indicator's color change are established through chemical research and development, and then validated through performance testing as described above.

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