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

The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI 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.

The provided document describes the STERIS Celerity Incubator, a device designed to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization.

Here's an analysis of the acceptance criteria and study information:

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 size used for the test set of biological indicators in the "Qualification Testing with intended Biological Indicators". It mentions "intended Biological Indicators for both Steam and Vaporized Hydrogen Peroxide Celerity Biological Indicators." No specific numbers are provided for these tests.

The data provenance (e.g., country of origin, retrospective or prospective) is not specified.

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

The document does not mention the use of human experts or their qualifications for establishing ground truth for the biological indicator testing. The ground truth appears to be based on a "7-day grow out" method, which is a laboratory standard for sterility verification rather than expert human interpretation.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned, as the validation process does not involve expert interpretation or subjective assessment that would require such a method.

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

No MRMC comparative effectiveness study was done. This type of study is typically performed for AI-powered diagnostic devices where human readers interpret medical images or data. The Celerity Incubator is an automated device for reading biological indicators.

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

Yes, a standalone study was performed. The "Qualification Testing with intended Biological Indicators" directly evaluates the automated fluorescent read of the device against a 7-day grow out method. This demonstrates the device's algorithmic performance in identifying viable organisms without human intervention in the result interpretation.

7. Type of Ground Truth Used

The type of ground truth used for the "Qualification Testing with intended Biological Indicators" is 7-day grow out. This is a standard microbiological method to determine if a sterilization process has been successful by attempting to culture any surviving microorganisms over a 7-day period.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This is because the Celerity Incubator is not an AI/machine learning model that requires a "training set" in the traditional sense. It's an automated device performing a specific detection function based on established scientific principles (fluorescence of enzymatic activity).

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

As there is no mention of a training set or an AI/machine learning model, the concept of establishing ground truth for a training set is not applicable to this device as described. The device's functionality relies on physical and chemical reactions and subsequent detection, rather than learning from a dataset.

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Use the Celerity HP Incubator to incubate and automatically read Celerity 20 HP Biological Indicators at 57 °C for a fluorescent result within 20 minutes.

Celerity HP Incubator (Incubator) is an incubator/reader designed for use specifically with the Celerity 20 HP Biological Indicator (BI). The incubator/reader provides a constant temperature range to allow for activation and outgrowth of Geobacillus stearothermophilus which is detected by an enzyme that cleaves the a substrate leading to production of a fluorescent moiety. The presence of an increasing fluorescence signal due to increasing concentrations of this fluorescent moiety in the BI is detected by the incubator/reader and indicates the presence of viable test microorganisms.

The provided text describes the acceptance criteria and the summary of performance testing for the Celerity HP Incubator (K190297). The information pertains to the device's adherence to safety and electromagnetic compatibility standards, and the proper function of its features, rather than a study involving human readers or a training set for an AI algorithm.

Here's a breakdown of the requested information based on the provided text:

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 a "test set" in the context of data or images, as this is a device for incubating and reading biological indicators. The performance tests are described as non-clinical and relate to the device's electrical safety, EMC, and functional aspects. No data provenance (country of origin, retrospective/prospective) is applicable or provided for this type of device 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 applicable. The "ground truth" for this device relates to established engineering and safety standards (UL, IEC, FCC) and the functional operation of the incubator and its indicators. These are validated through standard technical testing, not expert consensus on medical images or pathology.

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

This information is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or review of data (e.g., medical imaging), which is not the nature of the testing described for this device.

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:

No MRMC comparative effectiveness study was done, as this device (Celerity HP Incubator) is an automated incubator/reader for biological indicators, not an AI-assisted diagnostic tool that involves human readers interpreting medical cases.

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

The device described is inherently a standalone system. It automatically reads Celerity 20 HP Biological Indicators for a fluorescent result. The performance study refers to the device's ability to conform to electrical, safety, and functional standards, which are evaluated autonomously against set criteria. The "algorithm" in this context is the internal logic and detection mechanism of the incubator to determine a positive or negative result from the biological indicator.

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

The "ground truth" for this device's performance tests are established international and national safety and electromagnetic compatibility standards (UL, IEC, FCC), as well as the functional specifications for the device's alarms, LEDs, and print outputs. A "PASS" conclusion indicates conformity with these predefined technical criteria. The performance testing also implies the accurate detection of fluorescence produced by the biological indicator, which is a chemical/biological truth based on microbial growth.

8. The sample size for the training set:

This information is not applicable. The device is not an AI algorithm that undergoes training on a dataset. Its functionality is based on direct physical and chemical detection principles.

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

This information is not applicable, as there is no AI 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 11140-5:2007 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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