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Use the ConFirm 20 Minute Incubator to incubate and automatically read ConFirm Rapid 20 Minute Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C-60°C for a fluorescent result.

The ConFirm 20 Minute Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The Bl is incubated at 59°C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.

While the provided text describes the "ConFirm 20 Minute Incubator" and its 510(k) submission, it explicitly states under the "Summary of Non-Clinical Testing" section that "Testing was performed to evaluate performance and demonstrate substantial equivalence to the predicate as summarized in Table 2." Following this, Table 2 only contains "Regression Testing" with an acceptance criterion of "No unresolved anomalies" and a result of "PASS."

This document does NOT contain a study that proves the device meets specific performance acceptance criteria for its intended function (automatically reading biological indicators with a certain accuracy, sensitivity, or specificity). It primarily highlights that the "ConFirm 20 Minute Incubator" is substantially equivalent to a predicate device (Celerity Incubator K223715) based on technological characteristics and that regression testing passed.

Therefore, I cannot fulfill the request to describe a study proving the device meets performance acceptance criteria for reading biological indicators, as that information is not present in the provided text. The document focuses on regulatory equivalence rather than detailed performance study results.

However, based on the information provided, I can infer and state what is present and what is absent from the document regarding acceptance criteria and performance studies:

Analysis of Acceptance Criteria and Device Performance (Based only on provided text):

The provided 510(k) summary for the "ConFirm 20 Minute Incubator" (K233681) does not detail specific performance acceptance criteria related to its ability to accurately incubate and read biological indicators (e.g., sensitivity, specificity, accuracy rates). Instead, the evaluation focuses on demonstrating substantial equivalence to a predicate device (Celerity Incubator K223715) and passing regression testing.

The only explicit "acceptance criteria" and "result" provided in the "Summary of Non-Clinical Testing" (Table 2) are for Regression Testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not specified. The document does not provide details on sample size for any performance testing related to the incubation and reading of biological indicators. The "Regression Testing" mentioned in Table 2 is a general software/system testing term and does not imply a specific sample size for a clinical or performance study of the device's primary function.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable/Not specified. The document does not describe any study involving expert readers or establishment of ground truth in the context of device performance in reading biological indicators. The assessment relies on a comparison to a predicate device and internal regression testing.

4. Adjudication Method for the Test Set:

• Not applicable/Not specified. As no multi-reader or similar performance study is described, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, a MRMC comparative effectiveness study was not done according to the provided text. The device is an incubator/reader for biological indicators, not an AI-assisted diagnostic tool that would typically involve a multi-reader study with human interpretation.

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

• Not specified/Not applicable in the typical AI sense. While the device "automatically read[s]" results, the document does not present a standalone performance study with metrics like sensitivity, specificity, or accuracy for this automated reading function. The evaluation focuses on substantial equivalence to a predicate.

7. The Type of Ground Truth Used:

• Not specified. For the "Regression Testing," the ground truth would likely be defined by expected system behavior or documented requirements. For the primary function of reading biological indicators, the inherent ground truth would be the actual viability of the microorganisms within the biological indicator, often determined by traditional microbiological culture methods (which are not mentioned here as part of a performance study).

8. The Sample Size for the Training Set:

• Not applicable. The device is an incubator and reader for biological indicators, not an AI/ML device that requires a training set in the conventional sense.

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

• Not applicable. As the device is not an AI/ML device with a training set, this information is not relevant or provided.

In summary, the provided FDA 510(k) letter and summary focus on demonstrating substantial equivalence to a legally marketed predicate device (Celerity Incubator) and passing internal regression testing. It does not present detailed performance studies with specific statistical metrics (e.g., accuracy, sensitivity, specificity) for the device's core function of interpreting biological indicators, nor does it discuss clinical studies, human readers, or AI algorithms in the context of diagnostic performance.

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The Celerity 20 STEAM Biological Indicator for IUSS is used for monitoring and qualification testing of the following steam sterilization cycles: Gravity 270°F (132°C) 3 minutes Gravity 270°F (132°C) 10 minutes Gravity 275°F (135°C) 3 minutes Gravity 275°F (135°C) 10 minutes.

When used in conjunction with the Celerity STEAM Incubator provides a fluorescent result within 20 minutes.

The product is intended to monitor the critical parameters of steam sterilization cycles described in the indications for use by producing an optical change (signal) that is detected by the STERIS proprietary reader, Celerity 20 Steam Incubator in 20 minutes to confirm the viability of the biological indicator at the end of a steam sterilization process. The product consists of a biological organism known to be resistant to steam (Geobacillus stearothermophilus) and a defined nutrient media. A reporter enzyme, which is produced by the native organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

The provided text describes the Celerity 20 Steam Biological Indicator for IUSS, a Class II medical device used for monitoring and qualification testing of steam sterilization cycles. The document is a 510(k) Premarket Notification from the FDA, indicating a submission for substantial equivalency to a legally marketed predicate device.

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

Acceptance Criteria and Reported Device Performance

The core of the device's validation is presented in "Table 5-2. Summary of Non-clinical Testing" on page 7.

Study Details:

Based on the provided document, the study is a non-clinical performance testing of a biological indicator (BI) to demonstrate its efficacy in monitoring steam sterilization cycles. This is not a human clinical trial involving patients.

1. Sample Size used for the test set and the data provenance:

   • Sample Size: The document does not explicitly state the numerical sample sizes for each test (e.g., number of BIs tested for RIT, viable spore population, etc.). It only provides "PASS" or quantitative results (e.g., survival times).
   • Data Provenance: The data is generated from non-clinical laboratory testing performed by STERIS Corporation. The document does not specify the country of origin of the data beyond STERIS being a US-based company with manufacturing facilities listed in Mentor, Ohio. The studies are prospective in nature, as they involve performing new tests to evaluate the device.

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

   • This question is not applicable in the context of this device. The ground truth for a biological indicator is typically established by physical and microbiological testing against established standards (e.g., ISO, FDA guidance) and the known resistance of the Geobacillus stearothermophilus spores to steam sterilization. It does not involve human experts judging images or patient outcomes. The "ground truth" for each test is the defined acceptance criterion (e.g., specific spore population count, survival time, kill time).

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

   • None. Adjudication methods like 2+1 or 3+1 are used in studies where human readers (e.g., radiologists) interpret data or images, and their interpretations are compared and resolved by consensus. This is a non-clinical laboratory study evaluating a physical device's performance against predefined technical specifications.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human interpretation is involved. This document describes a biological indicator, which is a physical device used to confirm sterilization, not an AI or diagnostic tool that assists human interpretation.

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

   • Yes, a form of "standalone" performance was effectively done. The tests summarized in Table 5-2 evaluate the device's intrinsic performance (e.g., spore population, resistance, incubation time accuracy) as a standalone product. The device itself (the biological indicator with its integrated media and "reporter enzyme") produces the fluorescent result, which is then read by the Celerity STEAM Incubator. The incubator provides the final "fluorescent result within 20 minutes," which is an automated, objective output based on the biochemical reaction within the BI. There is no human interpretation of the BI's "result" other than observing the presence or absence of fluorescence from the incubator.

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

   • The ground truth is established by physical and microbiological standards and controlled laboratory conditions.
     • For viable spore population and resistance (D-values): Ground truth is based on established microbiological methods (e.g., dilution plating, plate counts) to quantify spore numbers and then exposing them to precisely controlled steam conditions to determine their resistance, in line with ISO and FDA guidance for BIs.
     • For Reduced Incubation Time (RIT): The ground truth is the "conventional incubation time of 7 days," meaning the BI is incubated for 7 days to definitively confirm growth or no growth, and this result is compared to the 20-minute fluorescent reading.
     • For Survival Time and Simulated Use: The ground truth is the presence or absence of viable spores after exposure to defined steam sterilization parameters (abbreviated cycle for growth, full cycle for kill) confirmed by subsequent incubation.

7. The sample size for the training set:

   • Not applicable/Not specified in this document. This document describes the performance testing for regulatory submission (510(k)). For a traditional medical device (like this biological indicator), there isn't typically a "training set" in the machine learning sense. Device development and optimization prior to this stage would involve extensive internal R&D, but the data presented here is from verification and validation testing, not a training set for an AI model.

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

   • Not applicable. As explained above, there's no "training set" in the AI sense for this type of device. The specifications and performance thresholds for biological indicators are established through scientific principles of microbiology, sterilization efficacy, and adherence to international standards (e.g., ISO 11138 series) and regulatory guidance from bodies like the FDA.

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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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