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The CELERITY Biological Indicator is used for routine monitoring, and qualification of the Non Lumen, Flexible, Lumen and Fast Non Lumen Cycles of the V-PRO 1, 1 Plus, maX, 60 and maX 2 Low Temperature Sterilizers in healthcare facilities.

When used in conjunction with the VERIFY CELERITY 20 HP Incubator, the CELERITY 20 HP Biological Indicator provides a fluorescent result within 20 minutes.

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, CELERITY 20 HP Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

The provided document is a 510(k) premarket notification for a medical device called the CELERITY 20 HP Biological Indicator. This device is a sterilization process indicator and, as such, there is no AI/Algorithm component to its function. Therefore, several of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, how training ground truth was established, effect size of human readers with/without AI) are not applicable to this type of device.

Here's the relevant information that can be extracted:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document does not specify the exact number of biological indicators (BIs) used in the "Simulated Use" test. However, it implicitly refers to a "worst-case cycle with a worst-case load," which suggests a controlled laboratory setting.
• Data Provenance: The study appears to be a laboratory-based performance study conducted by STERIS Corporation (Mentor, OH, USA), as indicated by the "Summary of Nonclinical Tests." It is prospective in nature as it involves testing the device's performance under specified conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is a physical biological indicator, not an AI/algorithm-driven device requiring expert interpretation of results for ground truth. The "ground truth" is the known sterility condition of the sterilization cycle.

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

Not applicable. The result of a biological indicator is typically a clear "growth" or "no growth" binary outcome, observed directly by laboratory personnel following established protocols.

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

Not applicable, as this device is a biological indicator, not an AI system.

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

Not applicable, as this device is a biological indicator, not an AI system. The device itself (the biological indicator and its incubator) provides a standalone result (fluorescent signal within 20 minutes) without human-in-the-loop interpretation beyond reading the incubator's output.

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

The ground truth for this device's performance is the known sterility or non-sterility of the sterilization cycle. This is established through controlled laboratory conditions where cycles are designed to either sterilize completely or to represent a "worst-case" scenario that should prevent complete inactivation of the BI. The "no growth of BI" result is then compared against this known condition.

8. The sample size for the training set

Not applicable, as this device does not use an AI/algorithm that requires a training set.

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

Not applicable, as this device does not use an AI/algorithm that requires a training set.

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