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The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature at the beginning of the final minute of a three and a half minute cycle, the indicator will demonstrate incomplete color change in the indicator window). The test parameters used for validating this device were 134℃ for 3.5 minutes with a 2 minute dry time.

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization a biological indicator, integrating indicator or both a biological and integrating indicator from the following list.

• · 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
• · 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company
• Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
• · Celerity 20 Steam Biological Indicator
• · VERIFY STEAM Integrating Indicator
• · VERIFY SixCess MF4 STEAM Emulating Indicator

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY STEAM Integrating Indicator.

The VERIFY All-In-One STEAM Resuable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Readout Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°P/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Resuable Test Pack.

The VERIFY All-In-One STEAM Reusable Test Pack employing the Celerity Xtend 10 Assembly with a Celerity 20 STEAM Biological Indicator and a Celerity 10 STEAM Chemical Indicator can be used for routine monitoring of 10minute 270°F/132°C dynamic air removal steam sterilization cycles. The sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

The VERIFY All-in-One STEAM Reusable Test Pack consists of a reusable aluminum tube with a tortuous path challenge for air removal and steam penetration. The VERIFY All-in-One STEAM Reusable Test Pack will be used with the Celerity Xtend 10 Assembly containing the Celerity 20 STEAM Biological Indicator and the Celerity 10 STEAM Chemical Indicator.

The Celerity Xtend 10 Assembly consists of a tube and cap design, comprised of one (1) polypropylene tube and one (1) silicone rubber cap containing one (1) Celerity 20 STEAM Biological Indicator and one (1) Celerity 10 STEAM Chemical Indicator and can only be used with the VERIFY A11-in-One STEAM Reusable Test Pack. The Celerity Xtend 10 Assembly has a tamper evident seal that will be broken once the assembly has been opened after use. A broken tamper evident seal will indicate to the user that it cannot be reused. The Celerity Xtend 10 Assembly is a single use device used for routine monitoring of 10-minute 270°F pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Reusable Test Pack.

The Celerity 20 STEAM Biological Indicator monitors the critical parameters of steam sterilization cycles by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity STEAM Incubator, in 20 minutes to confirm viability of the biological indicator at the end of a steam sterilization process. Both the Celerity 20 STEAM Biological Indicator has been cleared under K173634 and K181429 and the Incubator has been cleared under K173670.

The Celerity 10 STEAM Chemical Indicator is a single-use device used to monitor a 10-minute 270°F/132°C dynamic air removal steam sterilization cycle and is subject of a concurrent premarket notification.

Here's a breakdown of the acceptance criteria and study information for the VERIFY All-In-One STEAM Reusable Test Pack, based on the provided FDA 510(k) summary:

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 the "Simulated Use" and "Celerity Xtend 10 Assembly in pack vs Celerity Xtend 10 Assembly outside of pack" tests. The data provenance (country of origin, retrospective/prospective) is also not specified.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. This type of information is usually relevant for studies involving subjective human interpretation (e.g., image analysis), which is not the primary focus of this device (a sterilization process indicator).

4. Adjudication Method for the Test Set:

The document does not mention an adjudication method for the test set. Given the nature of the device (a pass/fail indicator for sterilization), an adjudication method relying on multiple human readers is typically not applicable. The “ground truth” for effectiveness of sterilization indicators is typically objective, based on microbiological culture or physical/chemical changes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. This device is a sterilization process indicator and does not involve AI assistance or human reader interpretation in the context of diagnostic decision-making.

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

The performance studies described ("Simulated Use" and "Celerity Xtend 10 Assembly in pack vs Celerity Xtend 10 Assembly outside of pack") appear to be evaluating the standalone performance of the device (the VERIFY All-In-One STEAM Reusable Test Pack in conjunction with its indicators). The "pass" conclusions suggest acceptable standalone performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

For sterilization indicators like this device, the ground truth is typically based on:

• Microbiological Culture: For biological indicators (BI), "pass" means the BI did not grow microorganisms after sterilization, indicating effective sterilization. "Fail" means growth, indicating ineffective sterilization.
• Physical/Chemical Changes: For chemical indicators (CI) like the Celerity 10 STEAM Chemical Indicator, the ground truth is based on a specific, observable color change (e.g., yellow to blue/purple) which correlates with exposure to critical sterilization parameters.
• Reference Standards: Comparison against established and validated sterilization process challenges (e.g., ANSI/AAMI/ISO standards for temperature differences or air removal efficiency).

The document mentions "conditions are met and proper vacuum is achieved" and "2°C (+1°C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-5:2007 Standard Test Pack and the drain temperature," suggesting a ground truth based on physical parameters validated against international standards for sterilization and microbiological efficacy.

8. The Sample Size for the Training Set:

The document does not provide information about a "training set" in the context of machine learning or AI. This device is a physical indicator system, not an AI/algorithm-based device that would typically use a training set. The development of such devices relies on engineering, material science, and microbiology, with validation studies rather than training sets.

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

This question is not applicable as there is no mention of a training set for this device.

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The VERIFY All-In-One STEAM Reusable Test Pack, when used with a VERIFY Bowie Dick Indicator Strip, is designed for testing the air removal efficiency of pre-vacuum steam sterilizers. The indicator will demonstrate complete dye migration when proper sterilization conditions are met and proper vacuum is achieved. If there is inadequate vacuum such that would result in a 2°C (+1° C/-0°C) temperature difference between the center of the ANSI/AAMI/ISO 11140-52007 Standard Test Pack and the drain temperature at the beginning of the final minute cycle. the indicator will demonstrate incomplete dye migration (incomplete color change in the indicator window). The test parameters used for 134°C for 3.5 minutes with a 2 minute dry time.

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterilization cycles. It is validated to be used in 4-minute 270°F/132° C pre-vacuum steam sterlization cycles utilizing a biological indicator or both a biological and integrating indicator from the following list.

• 3M ATTEST Rapid Read Biological Indicators catalog number 1292 manufactured by 3M Company
• . 3M ATTEST Super Rapid Read Biological Indicators catalog number 1492V manufactured by 3M Company
• Smart-Read EZTest Self Contained Biological Indicators for steam manufactured by MesaLabs, Inc.
• . Celerity 20 Steam Biological Indicator
• . VERIFY STEAM Integrating Indicator

VERIFY All-In-One STEAM Reusable Test Pack is designed to challenge the steam sterilization process in healthcare facilities. It is intended to be used for routine monitoring of pre-vacuum steam sterlization cycles. It is validated to be used in 4-minute 270°F/132°C pre-vacuum steam sterilization cycles with the VERIFY STEAM Integrating Indicator.

The VERIFY All-In-One STEAM Resuable Test Pack employing the All-in-One PV10 Assembly (a disposable polypropylene sleeve assembly) with a 3M ATTEST Rapid Biological Indicator catalog number 1292 can be used for routine monitoring of 10-Minute 270°F/132°C pre-vacuum steam sterilization cycles. The polypropylene sleeve assembly is intended to be used only with the VERIFY All-In-One STEAM Resuable Test Pack.

The VERIFY All-in-One STEAM Reusable Test Pack (formerly identified as the Dana Reusable Test Pack) consists of a reusable aluminum tube with a tortuous path challenge for air removal and steam penetration. The VERIFY All-in-One STEAM Reusable Test Pack will be used with the Celerity 20 Steam Biological Indicator (subject of a separate, concurrent 510(k) premarket notification) with or without the VERIFY STEAM Integrating Integrator (cleared under K152630).

The Celerity 20 Steam Biological Indicator monitors the critical parameters of steam sterilization cycles by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity Steam Incubator in 20 minutes to confirm viability of the biological indicator at the end of a steam sterilization process. Both the Celerity 20 Steam Biological Indicator and Incubator are subjects of separate 510(k) premarket notifications.

The VERIFY STEAM Integrating Integrator (cleared in K152630) is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY |STEAM Integrating Integrator may be included in the pack and processed according to the pack's instructions for use.

The user will place the assembled VERIFY All-in-One STEAM Reusable Test Pack containing the Celerity 20 Steam Biological Indicator with or without the VERIFY STEAM Integrating Integrator into the sterilizer chamber and perform a 4-minute 270°F pre-vacuum steam sterilization cycle.

At the end of the cycle, the user will remove the Celerity 20 Steam Biological Indicator and the VERIFY |STEAM Integrating Integrator from the pack. The Celerity 20 Steam Biological Indicator can either be immediately activated or held at room temperature for a maximum of 72 hours (3 days) prior to activation by twisting the cap and thus puncturing the cap to release the contained media. The activated BI is incubated at 55-60°C in the Celerity Steam Incubator for a final determination of viability within 20 minutes of incubation.

The VERIFY |STEAM Integrating Integrator will be evaluated for a passing or failing result by observing the dark bar of the device. If the dark bar enters the ACCEPT (OK) window, the integrator is read as a PASS. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL.

The provided text describes the acceptance criteria and a summary of non-clinical tests for the VERIFY™ All-in-One STEAM Reusable Test Pack. Here's a breakdown of the information you requested, based on the provided document:

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

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

The document does not specify the exact sample sizes used for the non-clinical tests. It also does not directly state the provenance (e.g., country of origin, retrospective or prospective) of the data. Given the nature of these tests for a sterilization indicator, it's highly likely they are conducted in a laboratory setting, making them a form of prospective, controlled testing.

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. The tests seem to rely on observable outcomes (e.g., BI viability, chemical integrator color change), which are typically objective and may not require expert adjudication in the same way as, for instance, image interpretation.

4. Adjudication method for the test set:

The document does not specify an adjudication method (like 2+1, 3+1). The "Conclusion" column in the table simply states "PASS," implying a direct assessment against the acceptance criteria.

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 a medical device for sterilization monitoring, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study is not applicable and was not performed.

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

The device is a physical test pack for sterilization. It does not involve an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed. The performance described is for the physical indicator device itself.

7. The type of ground truth used:

The ground truth for these tests appears to be based on:

• Performance of the Biological Indicator (BI): In this context, the ground truth for BI performance would be the viability or non-viability of the spores, determined by incubation and observation, which is a direct measure of sterilization effectiveness against microbial life.
• Performance of the Chemical Integrator (CI): The ground truth for CI performance is the visual assessment of dye migration or color change against predefined criteria, indicating the achievement of sterilization conditions.
• AAMI 16 towel test pack: This is a recognized standard challenge test pack, used as a comparative benchmark to establish the "equivalent or greater challenge" of the VERIFY pack.

8. The sample size for the training set:

This device is not an AI/ML model, so the concept of a "training set" is not applicable. The device's performance is established through physical testing, not machine learning.

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

As mentioned above, the device is not an AI/ML model, so the concept of a "training set" and establishing ground truth for it is not applicable.

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