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The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter. The VERIFY™ VH2O2 Indicator Tape is also intended to be used as an external process indicator when applied to synthetic wrap materials and/or Tyvek pouches.

The tape may be used in the following sterilization cycles:

• Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Sterlizers
• · Standard Cycle of the STERRAD® 100S Sterilizer
• · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
• · Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer

The VERIFY VH2O2 Indicator Tape consists of a special coated crepe paper with diagonal lines of a chemical indicator specific for hydrogen peroxide sterilization. It meets the performance specifications for a Type 1 process indicator as defined in ANSI/AAMI/ISO 11140-1:2014.

The VERIFY | VH2O2 Indicator Tape and its packaging are manufactured in the absence of lead, heavy metals, natural rubber latex and dry natural rubber.

The provided document is a 510(k) summary for the VERIFY™ VH2O2 Indicator Tape, a Class II medical device (Sterilization Process Indicator). It details the device's characteristics and compares it to a predicate device (VERIFY™ VH2O2 Indicator Tape, K160485) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of formal acceptance criteria with specific numerical targets. However, it implies acceptance based on compliance with standards and successful performance in specific tests. The key performance indicators evaluated are:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes (e.g., number of indicator tapes tested) for the simulated use testing or stability testing. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

The testing for the current submission focused on:

• "performance was tested in the V-PRO maX 2's Fast Non Lumen Cycle with loads under simulated use conditions under pass and fail conditions."
• "Shelf-life testing evaluated CI performance per ANSI/AAMI/ISO 11140-1:2014, endpoint color stability and tape adhesion after various times of storage within the labeled storage conditions."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the VERIFY™ VH2O2 Indicator Tape. This device is a chemical indicator that undergoes a physical color change. Its performance is evaluated objectively against chemical parameters and color charts, not through expert interpretation of complex medical images or diagnoses. Therefore, there's no mention of experts establishing a "ground truth" in the way it would be for a diagnostic AI device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As noted above, the device's performance is based on a direct chemical reaction resulting in a color change, which is evaluated against established physical criteria (e.g., an industry standard color chart or specific chemical exposure levels), rather than subjective interpretation requiring adjudication.

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

Not applicable. The VERIFY™ VH2O2 Indicator Tape is a standalone chemical indicator, not an AI-assisted diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is inherently a "standalone" indicator. Its performance is entirely determined by its chemical reaction to hydrogen peroxide and the resulting color change, without any human-in-the-loop interaction beyond observation. The reported "Simulated Use Testing" and "Stability Testing" are essentially standalone performance evaluations of the indicator tape itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance relies on objective chemical and physical parameters as defined by:

• ANSI/AAMI/ISO 11140-1:2014 Type 1 requirements: This standard defines the performance characteristics for process indicators, including the specific conditions (e.g., concentration of sterilant, temperature) under which the indicator must change color, and the expected color change.
• Sterilization cycle parameters: The device is tested against the actual sterilization cycles of specific sterlizers (e.g., V-PRO maX 2, STERRAD 100S, STERRAD NX, STERRAD 100 NX) under "pass and fail conditions." The "ground truth" here is whether the sterilization process itself was successful or not, based on the validated parameters of the sterilizer, and whether the indicator accurately reflected that state.
• Visual color change: The ground truth for distinguishing processed from unprocessed units is the observed color change from pink to peach, yellow, or lighter. This is a direct physical observable.

8. The sample size for the training set

Not applicable. This device is a chemical indicator, not a machine learning or AI algorithm that requires a "training set." Its design and performance are based on chemical engineering and adherence to international standards, not data-driven learning.

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

Not applicable, for the same reason as point 8.

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The VERIFY™ VH2O2 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change from the start color (pink) to peach, yellow or lighter.

The tape may be used in the following sterilization cycles:

• · Non Lumen, Flexible and Lumen Cycles of the V-PRO 1, 1 Plus, maX and 60 Low Temperature Sterilizers
• · Standard Cycle of the STERRAD® 100S Sterilizer
• · Standard and Advanced Cycles of the STERRAD® NX Sterilizer
• · Express, Flex Scope, Duo and Standard Cycles of the STERRAD® 100 NX Sterilizer

The VERIFY VH2O2 Indicator Tape consists of a special coated crepe paper with diagonal lines of a chemical indicator specific for hydrogen peroxide sterilization. It meets the performance specifications for a Type 1 process indicator as defined in ANSI/AAMI/ISO 11140-1:2014.

The VERIFY | VH2O2 Indicator Tape and its packaging are manufactured in the absence of lead, heavy metals, natural rubber latex and dry natural rubber.

The medical device is the VERIFY™ VH2O2 Indicator Tape, which is a chemical sterilization process indicator.

Here's an analysis of the provided information, addressing your specific questions:

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 specific sample sizes for each test in the test set. It mentions tests being conducted "in an ANSI/AAMI/ISO 18472:2006-conforming resistometer" and "in hydrogen peroxide sterilizers (V-Pro and STERRAD) with loads under simulated use conditions." The provenance of the data is not explicitly stated as country of origin, but it is implied to be from the manufacturer's (STERIS Corporation) testing, which is based in Mentor, Ohio, USA. The testing appears to be prospective as it was conducted to demonstrate the performance of the new device.

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

This information is not provided in the document. For chemical indicators like this, ground truth is typically established by physical/chemical properties and standardized tests, not by human expert interpretation in the same way an imaging AI might be evaluated. The "Pass" results are against established standards (ANSI/AAMI/ISO).

4. Adjudication Method for the Test Set

This information is not applicable in the traditional sense for a chemical indicator. The "Pass" or "Fail" of the tests is determined by adherence to predefined measurable criteria set forth in the ISO standards and internal performance specifications, rather than by a panel of human adjudicators reviewing outputs.

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 conducted for diagnostic devices where human interpretation of results is involved, and the AI's impact on human performance is being assessed. The VERIFY™ VH2O2 Indicator Tape is a chemical indicator that provides a direct visual color change, not an interpretive diagnostic.

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

Yes, the testing performed can be considered "standalone" in the sense that the device's performance (color change, adhesion, stability) was evaluated directly against scientific and industry standards without a human-in-the-loop component for the device's core function. The device itself is designed to provide a clear, unambiguous signal (color change) that indicates processing. The evaluation focuses on whether this signal occurs accurately and reliably under specified conditions.

7. The Type of Ground Truth Used

The ground truth used is based on established industry standards and physical/chemical properties. This includes:

• ANSI/AAMI/ISO 11140-1:2014: This standard defines the requirements for chemical indicators for sterilization.
• ANSI/AAMI/ISO 18472:2006: This standard relates to resistometers, which are used to evaluate sterilization processes and indicators.
• ASTM adhesion standard: Used for evaluating tape adhesion.
• Measurable parameters for color change (from pink to peach/yellow or lighter) under defined sterilization conditions (pass conditions) and no change under fail conditions.
• Shelf-life stability of the indicator.
• Residual chemical levels (hydrogen peroxide).

8. The Sample Size for the Training Set

This document describes a physical device, a chemical indicator tape, not an algorithm that requires a "training set" in the context of machine learning or AI. Therefore, the concept of a training set sample size does not apply.

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

As explained above, this device does not utilize a training set in the AI sense. Ground truth relates to the performance standards and physical/chemical characteristics of the indicator itself, established by international and industry standards, and verified through laboratory and simulated-use testing.

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