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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 text describes the Celerity Incubator, a Class II medical device, and its performance testing to demonstrate substantial equivalence to a predicate device. This device is designed to incubate and automatically read STERIS Celerity Biological Indicators for sterilization processes.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each test (e.g., how many biological indicators were tested for the Qualification Testing or how many barcodes were tested for recognition).

• Data Provenance: The document generally refers to "performance testing" conducted by STERIS Corporation for their 510(k) submission. It does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would typically be prospective, conducted under controlled laboratory conditions to demonstrate performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide details on the number of experts used or their qualifications for establishing ground truth, as the ground truth appears to be based on physical biological indicator growth ("7-day grow out") rather than expert review of complex images or data.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for the biological indicator test is the physical 7-day grow out, which is an objective measure, not a subjective interpretation requiring adjudication among experts.

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

Not applicable. The Celerity Incubator is a device that automates the reading of biological indicators, not an AI system assisting human readers with interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone Performance (Algorithm Only)

Yes, the testing described appears to be a standalone performance evaluation of the Celerity Incubator's ability to accurately read biological indicators, without human intervention in the reading process itself. The incubator performs the incubation and optical reading automatically.

7. Type of Ground Truth Used

The primary ground truth for the "Qualification Testing with intended Biological Indicators" is 7-day grow out of the biological indicators. This is an objective measure where biological indicators are incubated for a standard 7-day period to definitively determine if microbial growth occurred, which signifies a sterilization failure. The fluorescent reading from the Celerity Incubator is then compared against this established 7-day grow out result. For "Software Validation" and "Recognition of additional barcodes," the ground truth would be based on the intended functional specifications and correct barcode decoding, respectively.

8. Sample Size for the Training Set

Not applicable. This device is an automated incubator and reader, not an AI/ML device that requires a "training set" in the context of machine learning model development. Its function relies on established physical and optical principles for detecting fluorescence, not on learning from a large dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this device in the context of AI/ML.

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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.

Here's an analysis of the provided text regarding the Celerity Incubator's acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample size used for the "Qualification Testing with intended Biological Indicators" which is the most relevant performance test described. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. The acceptance criterion mentions "7-day grow out per FDA guidance," implying a standard microbiological method for determining growth, which typically doesn't involve "experts" in the sense of clinical reviewers.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. The "7-day grow out" is a definitive biological outcome, not typically subject to adjudication in the same way clinical image reviews might be.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is an incubator for biological indicators, not a diagnostic imaging or AI-assisted diagnostic tool that would typically involve human readers.

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

Yes, a standalone performance test was done, referred to as "Qualification Testing with intended Biological Indicators." This test assesses the device's ability to accurately detect fluorescence in biological indicators, which is an automated process without human interpretation in the results pathway. The "human factors" test evaluates user interaction, but the core performance related to detecting BI growth is standalone.

7. The Type of Ground Truth Used

The type of ground truth used for the "Qualification Testing with intended Biological Indicators" is biological growth/non-growth, as determined by a "7-day grow out" method. This is a functional, objective ground truth based on the viability of microorganisms.

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. This is because the Celerity Incubator is a hardware device with embedded software for interpreting biological indicator results based on a known biochemical reaction (fluorescence). It doesn't appear to be an AI/machine learning model in the typical sense that would require a separate training set for algorithm development.

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

As there is no mention of a traditional training set for an AI/ML algorithm, the concept of establishing ground truth for a training set in this context is not applicable or described in the document. The device's operation is based on established principles of fluorescence detection for biological activity, rather than learning from a dataset.

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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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