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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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