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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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The Celerity 20 Steam Biological Indicator is used for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization cycles:

• · Dynamic Air Removal 270°F (132°C) 4 minutes
• · Dynamic Air Removal 275°F (135°C) 3 minutes
• · Gravity 250°F (121°C) 30 minutes
• · Gravity 270°F (132°C) 15 minutes.
  When used in conjunction with the Celerity™ Steam Incubator, the 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 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.

Here's an analysis of the provided information to answer your questions about acceptance criteria and the study that proves the device meets them:

Device: Celerity 20 Steam Biological Indicator

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

Based on the document, only one performance test is explicitly mentioned with an acceptance criterion and conclusion:

The document also lists several technical characteristics for the Celerity 20 Steam Biological Indicator (modified) and compares them to the predicate device. While these aren't explicitly stated as "acceptance criteria" in the same way as the "Simulated Use" test, they represent performance parameters that the device is expected to meet and does meet, often being "Identical" to the predicate.

For completeness, here's a combined table including those technical characteristics as implicit acceptance criteria if one assumes they must match the predicate:

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

The document does not explicitly state the sample size used for the "Simulated Use" test or any other specific test. It also does not provide information about the data provenance (e.g., country of origin, retrospective or prospective nature).

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)

This type of information is not applicable to a biological indicator device. The "ground truth" for a biological indicator is determined by the presence or absence of microbial growth, which is an objective biological outcome rather than an expert interpretation.

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

Not applicable. As noted above, the determination of microbial growth is objective, not requiring human adjudication.

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. This device is a biological indicator, not an AI-assisted diagnostic tool requiring human reader studies.

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

Not applicable. This device is a biological indicator, not an algorithm. Its performance is inherent to its biological and chemical properties. The Celerity™ Steam Incubator provides an automated fluorescent result, which could be considered a "standalone" reading, but it's not an AI algorithm.

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

The ground truth used for relevant tests (like viability, resistance, survival, kill time, and simulated use) is based on the presence or absence of microbial growth (Geobacillus stearothermophilus), which is an objective biological outcome. This is determined through standard microbiological techniques.

8. The sample size for the training set

Not applicable. This device is a biological indicator, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

Not applicable. No training set is involved for this type of device.

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The Celerity 20 Steam Biological Indicator is used for routine monitoring, qualification testing, load monitoring and product testing of the following steam sterilization cycles:

• Dynamic Air Removal 270°F (132°C) 4 minutes
• Dynamic Air Removal 275°F (135°C) 3 minutes
• Gravity 250°F (121°C) 30 minutes
• Gravity 270°F (132°C) 15 minutes.
  When used in conjunction with the Celerity™ Steam Incubator, the 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 and its performance testing to demonstrate substantial equivalence to a predicate device. Here's a breakdown of the requested 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 specific "sample size" for each test set in numerical terms (e.g., number of biological indicators tested for RIT). It generally refers to "performance testing" and implicitly describes the methodologies rather than raw counts.

• Data Provenance: The studies were conducted by STERIS Corporation, the manufacturer, as part of their premarket notification to the FDA. The nature of the tests (e.g., RIT, Resistance, Survival/Kill Time, Simulated Use) implies controlled laboratory and simulated clinical environments rather than human patient data from a specific country. Therefore, it's not applicable in the same way as a clinical trial. It's a prospective evaluation of the device's technical performance.

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

This information is not provided because the device is a biological indicator for sterilization processes, not a diagnostic device requiring expert interpretation of results. The "ground truth" (e.g., whether sterilization occurred, spore viability) is determined by the inherent biological and chemical properties of the indicator and reference standards (e.g., ISO 11138-3, FDA guidance) rather than subjective expert consensus.

4. Adjudication Method for the Test Set

Not applicable for this type of device. The results are objective (fluorescence detected by an automated reader, growth/no growth, D-value calculation, etc.) and adhere to predetermined technical criteria. There is no subjective interpretation requiring adjudication among experts.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to evaluate the impact of AI on their performance. The CELERITY 20 Steam Biological Indicator is an automated indicator with no direct human-in-the-loop performance component in the diagnostic sense.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies described are essentially "standalone" performance evaluations of the device. The device itself, in conjunction with its specific incubator, provides a fluorescent result. The tests (RIT, Viable spore population, Resistance, etc.) evaluate the intrinsic performance of the biological indicator and its detection system without human interpretation as a primary outcome. The "algorithm" here refers to the biological and chemical reaction, and the automated detection by the Celerity™ Steam Incubator.

7. The Type of Ground Truth Used

The ground truth is established through:

• Biological and Chemical Standards: The viability of Geobacillus stearothermophilus spores and their resistance to steam are well-established biological principles and standards.
• International Standards: References to ISO 11138-3 are frequently made for resistance, survival, and kill time requirements.
• FDA Guidance: The RIT testing specifically refers to FDA's requirements.
• Reference Methods: The "conventional incubation time of 7 days" serves as a reference for establishing the accuracy of the reduced incubation time.
• Controlled Sterilization Cycles: For tests like "Simulated Use," the ground truth is predefined by subjecting the indicators to known "abbreviated" (fail) and "full" (pass) sterilization cycles.

8. The Sample Size for the Training Set

This information is not provided. Biological indicators, unlike AI algorithms for image analysis, do not typically undergo a "training set" development in the machine learning sense. Their performance is based on established biological and physical principles, manufacturing consistency, and validation against known standards.

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

As there is no "training set" in the context of an AI algorithm, this question is not applicable. The device's inherent design and manufacturing process are developed to meet the established biological and regulatory standards, which serve as the "ground truth" for its intended function.

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