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The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Flexible, Fast and Fast Non Lumen Cycles of the V-PRO® 1, 1 Plus, maX, maX 2, 60 and s 2 Sterilizers

· STERRAD® 100S Sterilizer (default cycle)

• STERRAD® 200 Sterilizer (default cycle)

· Standard and Advanced Cycles of the STERRAD® NX Sterilizers with All Clear Technology

· Express, Flex Scope and Standard Cycles of the STERRAD® 100NX Sterilizers with All Clear technology

The VERIFY V24 BI Challenge Pack is intended for qualification testing of the V PRO 1 Plus, VPRO maX, V-PRO maX 2, V-PRO 60 and V PRO s 2 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer. The user places the VERIFY V24 SCBI into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY V24 Biological Indicator Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included. The user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

Here's a breakdown of the acceptance criteria and study information for the VERIFY V24 Self-Contained Biological Indicator and VERIFY V24 Biological Indicator Challenge Pack, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that the document presents separate acceptance criteria and testing for the "Self-Contained Biological Indicator (SCBI)" and the "Challenge Pack."

For the VERIFY V24 Self-Contained Biological Indicator (SCBI):

For the VERIFY V24 Biological Indicator Challenge Pack:

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

The document does not explicitly state the numerical sample size used for the test set in any of the studies. It refers to "All test SCBIs" and "All processed SCBIs" without providing a count.

The data provenance is not specified beyond being "nonclinical tests" and "performance testing to demonstrate substantial equivalence to the predicate." There is no mention of country of origin or whether the studies were retrospective or prospective.

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. The document describes tests related to the biological and chemical indicators themselves and their performance in sterilization cycles, not a diagnostic or interpretive task that would typically involve human expert adjudication for ground truth.

4. Adjudication Method for the Test Set

This information is not provided as the tests described are objective measures of biological indicator performance (e.g., growth/no growth, color change, spore population) rather than subjective assessments 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

This is not applicable. The device described (Biological Indicator and Challenge Pack) is a sterilization process indicator, not an AI or imaging device that would typically be involved in human-in-the-loop diagnostic tasks or benefit from a reader study.

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

This is not applicable as the device is a physical biological indicator, not an algorithm. Its performance is evaluated through laboratory and simulated use testing.

7. The Type of Ground Truth Used

The ground truth for the performance tests appears to be based on:

• Biological viability: Growth or lack thereof of Geobacillus stearothermophilus spores after exposure to sterilization cycles, as determined by a color change in the growth medium.
• Established physical and chemical properties: D-value, survival time, kill time, and viable spore population are laboratory-measured physical characteristics against established standards.
• Chemical indicator color change: A visible, objective change in color on the indicator.
• Comparative resistance: The challenge pack's resistance compared to a "worst case biological model."

Essentially, the "ground truth" is defined by the expected biological or chemical response to a sterilization process.

8. The Sample Size for the Training Set

This is not applicable. There is no concept of a "training set" for a biological indicator. The tests described are performance and validation tests, not machine learning model training.

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

This is not applicable as there is no training set for this type of device.

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The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizers and cycles:

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

The VERIFY V24 Challenge Pack is intended for qualification testing of the V-PRO 1 Plus, V-PRO maX, V-PRO maX 2 and V-PRO 60 Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The VERIFY V24 Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The VERIFY V24 Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing the Sterilizers.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare facilites to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer.

The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY V24 Self-Contained Biological Indicator can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The VERIFY V24 Self-Contained Biological Indicator is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the VERIFY V24 Self-Contained Biological Indicator vial and releases the growth media.

The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The VERIFY V24 Self-Contained Biological Indicator indicates a pass if the media remains orange and non-turbid. The VERIFY V24 Self-Contained Biological Indicator indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY V24 Challenge Pack is used by healthcare facilities for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocations, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital defined challenge load is not included.

The user places the VERIFY V24 Challenge Pack into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55-60°C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

This document describes the acceptance criteria and study proving the VERIFY® V24 Self-Contained Biological Indicator (SCBI) and the VERIFY® V24 Challenge Pack meet these criteria.

VERIFY® V24 Self-Contained Biological Indicator

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated in the provided text for individual tests, but implied to be sufficient for each test type.
• Data Provenance: The studies were conducted by STERIS Corporation, the manufacturer. The information does not specify country of origin for specific data sets, but the company is located in the USA. The studies appear to be prospective, designed specifically for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. The "ground truth" for a biological indicator and its performance characteristics (like D-value, survival time, kill time, and growth/no-growth) are established through microbiological laboratory methods and adherence to recognized standards (e.g., FDA guidance on BI submissions, ISO 11138-1), not through expert consensus in the same way an AI diagnostic tool might be. The interpretation of results (growth/no growth, color change) is objective.

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

• Not applicable. This is a scientific and objective assessment of a biological and chemical indicator's performance against defined quantifiable metrics, not a subjective human 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. This is not an AI diagnostic device.

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

• Not applicable. This is a biological indicator that provides a visual readout.

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

• The ground truth is established through microbiological testing and adherence to established industry-specific standards and guidelines. This includes:
  • Direct enumeration of viable spores.
  • Controlled exposure to the sterilant (H₂O₂ at specific concentrations and times) to determine D-value, survival time, and kill time.
  • Incubation under controlled conditions to observe microbial growth (turbidity, color change) as an indicator of sterilization failure.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

VERIFY® V24 Challenge Pack

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated in the provided text for individual tests, but implied to be sufficient for each test type.
• Data Provenance: The studies were conducted by STERIS Corporation, the manufacturer, in the USA. The studies appear to be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Similar to the SCBI, the ground truth for the challenge pack's performance is based on objective microbiological and chemical indicator principles, not expert consensus.

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

• Not applicable.

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.

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

• Not applicable.

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

• The ground truth is established through microbiological testing and adherence to established industry-specific standards and guidelines for process challenge devices. This includes:
  • Comparison to a "worst-case biological model" to ensure adequate challenge.
  • Observation of growth/no-growth for the contained SCBI and color change for chemical indicators after exposure to sterilization cycles.

8. The sample size for the training set:

• Not applicable.

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

• Not applicable.

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The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the Lumen, Non Lumen and Flexible cycles of V-PRO® Low Temperature Sterilization Systems.

The VERIFY V24 Biological Indicator Challenge Pack is intended for qualification testing of the Lumen. Non Lumen and Flexible Cycles in V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.

The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.

The challenge pack is not intended for routine monitoring of V-PRO Sterliizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers to monitor the V-PRO® Low Temperature Sterilization Systems. It is designed to accompany medical devices placed in the sterilizer.

The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55 - 60 °C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY V24 Biological Indicator Challenge Pack is used by healthcare providers for qualification testing of the V-PRO Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospitaldefined challenge load is not included.

The user places the VERIFY V24 Biological Indicator Challenge Pack into the V-PRO Sterilizer and performs a sterilization cycle. After cvcle completion, the VERIFY HPU Chemical Indicator (CI) and the VERIFY V24 Self-Contained Biological Indicator (SCBI) contained in the challenge pack are retrieved. The CI is assessed for a passing color change immediately and the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.

The SCBI is activated by sealing the vial and rupturing the media ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.

The activated SCBI is incubated at 55-60 ℃ for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure if the media changes from orange to vellow and/or if the media is turbid.

This document describes two devices, the VERIFY® V24 Self-Contained Biological Indicator (SCBI) and the VERIFY® V24 Biological Indicator Challenge Pack. Both submissions are focused on qualifying these devices for use with the new V-PRO 60 Low Temperature Sterilization System, demonstrating substantial equivalence to their respective predicate devices.

VERIFY® V24 Self-Contained Biological Indicator (SCBI)

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document summarizes nonclinical tests without providing specific sample sizes for each test. The studies were conducted by STERIS Corporation. The data provenance is described as being for "the new V-PRO 60 unit," implying prospective testing for this specific sterilizer. The K numbers (K073244, K090514) indicate prior clearances and associated data.

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

This information is not provided within the document. The "ground truth" for biological indicators is inherently based on the viability of Geobacillus stearothermophilus spores, which is determined by culturing and observing growth or no-growth.

4. Adjudication Method for the Test Set:

This information is not provided within the document. The outcome (Pass/Fail, or sterile/non-sterile) for biological indicators is typically a direct observation of microbial growth or lack thereof.

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

This type of study is not applicable as the device is a biological indicator, not an imaging or diagnostic AI tool that involves human readers.

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

This is a standalone performance study. The device, a biological indicator, functions independently without a human in the loop for its direct performance, though human observation is required for interpreting its results (color change, turbidity).

7. Type of Ground Truth Used:

The ground truth used is the viability of Geobacillus stearothermophilus ATCC 7953 spores. A successful sterilization cycle should kill all spores, resulting in no growth (sterile). If spores survive, they will grow, indicating a sterilization failure. This is effectively a biological assay for sterility.

8. Sample Size for the Training Set:

The document does not specify a separate "training set" in the context of machine learning, as this is a biological indicator. All listed tests are performance evaluations for the device itself rather than training data for an algorithm.

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

Not applicable, as there is no training set in the machine learning sense. The biological principles of spore inactivation and growth underpin the ground truth for biological indicators.

VERIFY® V24 Biological Indicator Challenge Pack

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document summarizes nonclinical tests without providing specific sample sizes for each test. The studies were conducted by STERIS Corporation. The data provenance is described as being for "the new V-PRO 60 Sterilizer," implying prospective testing for this specific sterilizer. K103331 is cited as the predicate.

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

This information is not provided within the document. Similar to the SCBI, the ground truth for the challenge pack relies on the biological viability of Geobacillus stearothermophilus spores and the visual change of the chemical indicator.

4. Adjudication Method for the Test Set:

This information is not provided within the document. The outcome (Pass/Fail) is based on the biological indicator's growth/no growth and the chemical indicator's color change.

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

This type of study is not applicable as the device is a biological indicator challenge pack.

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

This is a standalone performance study. The challenge pack, containing a biological indicator and a chemical indicator, functions independently in the sterilizer without a human in the loop for its direct performance. Human observation is required for interpreting the results of both indicators.

7. Type of Ground Truth Used:

The ground truth used is the viability of Geobacillus stearothermophilus ATCC 7953 spores for the biological indicator component and the color change of the chemical indicator. Both are indicators of effective sterilization.

8. Sample Size for the Training Set:

The document does not specify a separate "training set" in the context of machine learning, as this is a biological indicator challenge pack. All listed tests are performance evaluations for the device itself.

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

Not applicable, as there is no training set in the machine learning sense. The biological principles of spore inactivation and growth, along with established chemical indicator responses to sterilization processes, underpin the ground truth.

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The VERIFY® V24 Self-Contained Biological Indicator is intended for routine monitoring of the following sterilizer cycles:

• Lumen, Non Lumen and Flexible Cycles of the V-PRO® Low Temperature . Sterilization Systems
• Default Cycle of the STERRAD 100S Sterilizer ●
• Default Cycle of the STERRAD 200 Sterilizer .
• Standard and Advanced Cycles of the STERRAD NX Sterilizer .
• Express, Standard and Flex Scope Cycles of the STERRAD 100NX Sterilizer .

The VERIFY V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers to monitor the V-PRO® Low Temperature Sterilization Systems and the STERRAD® 100S, STERRAD 200, STERRAD NX and STERRAD 100NX (Express, Standard and Flex Scope Cycles) Sterilizers. It is designed to accompany medical devices placed in the sterilizer.
The user places the VERIFY V24 Self-Contained Biological Indicator into the V-PRO Low Temperature Sterilization System or STERRAD Sterilizer and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation.
The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS VERIFY SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media.
The activated SCBI is incubated at 55 – 60 °C for ≥ 24 hours. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid.

The VERIFY® V24 Self-Contained Biological Indicator (SCBI) is intended to monitor specific cycles of V-PRO® Low Temperature Sterilization Systems and various STERRAD® Sterilizers. The acceptance criteria and supporting study are outlined below:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample size (number of VERIFY V24 SCBIs) used for each of the performance tests (Half Cycle, Growth Inhibition, Simulated Use).

The data provenance is for testing the device's compatibility with STERRAD Sterilizers. The context implies that the testing was likely conducted in a controlled laboratory or clinical setting in the United States, given that the sponsor and manufacturing facilities are in Mentor, OH, USA, and the submission is to the FDA. The study appears to be prospective, specifically designed to demonstrate the device's performance with the new sterilizer indications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. For biological indicators, the ground truth is typically established by observing the growth or non-growth of the bacterial spores, which is a direct, objective biological outcome. It doesn't usually rely on expert interpretation in the same way an imaging diagnostic might.

4. Adjudication method for the test set

The document does not describe an adjudication method for the test set. Given the nature of a biological indicator, where the outcome is a clear biological response (growth or no growth, indicated by a color change), an adjudication method by multiple experts is generally not applicable. The results are typically objectively measured.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and often AI assistance. The VERIFY V24 Self-Contained Biological Indicator is a direct biological indicator without a human-in-the-loop component for reading the primary outcome.

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

The device itself is a standalone indicator. Its performance is evaluated directly based on the biological outcome (spore inactivation and subsequent growth or no growth of Geobacillus stearothermophilus). This is essentially a standalone performance evaluation in that there is no "human-in-the-loop" for the primary interpretation of the device's result (color change or turbidity).

7. The type of ground truth used

The ground truth used is the biological outcome – specifically, the successful inactivation of Geobacillus stearothermophilus spores and the presence or absence of their growth after exposure to a sterilization process. This is determined by observing the color change of the media (orange to yellow) and/or turbidity, which indicates viable spores. The specification ranges for D-value, survival time, and kill time are also integral to establishing the efficacy (ground truth) of the indicator.

8. The sample size for the training set

The document does not detail a separate "training set" or its size, as this device is a biological indicator and not an AI/ML-based system that typically requires a training set. The existing biological indicator has been previously cleared, and the current submission focuses on extending its use to additional sterilizers.

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

Not applicable, as there is no mention of a "training set" in the context of an AI/ML model for this biological indicator. The existing performance characteristics of the Geobacillus stearothermophilus spores and the indicator's components (media, etc.) were established through previous studies (K073244, K090514) according to FDA guidance for biological indicators.

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