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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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