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Use the BCR-30-min BI™ and the RBIP-ST30™ together for monitoring performance of gravity displacement steam sterilization cycles of 30 minutes at 250°F (121°C). The BCR-30-min BI™ in conjunction with the RBIP-ST30™ provides final fluorescence results in 30 minutes.

The BCR-30-min BI™ is designed to be used with its readout accessory, the RBIP-ST30™ robotic processor, for validating and challenging performance of gravity displacement steam sterilization cycles at 250°F (121°C). The BCR-30-min BI™ consists of a strip (6.0 x 60 mm) of filter paper (Whatman GF/A) inoculated in the center with about 106 living spores of Geobacillus stearothermophilus ATCC No. 7953. The strip is packaged in a #30 blue glassine pouch (1 x 3 inch). The BCR-30-min BI™ should be placed in the center of the load or in the most difficult to sterilize area.

In the RBIP-ST30™, the spores of the BCR-30-min BI™ are first converted into Fspores™ and then they are incubated for 30 min at 55±2°C to allow germination of living Fspores™. The device utilizes the fact that F-spores™ are not fluorescent per se but produce intense fluorescence when germinated. Accordingly, the RBIP-ST30™ detects failure of a steam sterilization cycle when significant fluorescence is present. The RBIP-ST30™ is designed to automatically process the BCR-30-min BI™ to obtain a fluorescence reading within 30 minutes.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BCR-30-min BI™ and RBIP-ST30™ Readout Accessory.

1. Table of Acceptance Criteria and Reported Device Performance

Summary of the Study and How the Device Meets Acceptance Criteria:

The study aims to demonstrate substantial equivalence of the BCR-30-min BI™ and RBIP-ST30™ Readout Accessory to legally marketed predicate devices. The acceptance criteria are largely defined by the performance characteristics of the predicate devices and relevant industry standards/guidance.

The device meets the acceptance criteria by showing comparable performance in critical areas such as spore population, resistance characteristics (D-Value, Z-Value, Survival Time, Kill Time), and alignment with established incubation protocols. Specifically, the new device achieves a fluorescence result in 30 minutes with greater than 97% correlation to the 7-day visual readout, which is a significant improvement in readout time compared to the predicate's 180 minutes, while still meeting the required performance standard. The readout accessory also demonstrates equivalent function and safety based on its intended use, incubation temperature, detection method, and compliance with safety and EMC standards.

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

• Sample Size for BCR-30-min BI™: Performance was determined using three (3) separate spore lots from independent spore cultures. The specific number of individual BI units tested per lot is not explicitly stated but implied to be sufficient for determining D-value, Z-value, survival, and kill times.
• Data Provenance: The document does not specify the country of origin. It indicates the study followed FDA guidance and international standards (ANSI/AAMI/ISO). It is a retrospective analysis in the sense that it compares to established predicate device data and standards, but the testing of the new device itself would have been prospective to generate the new data for submission.

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

This type of device (biological indicator for sterilization) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The "ground truth" here is objective: whether the spores are killed by sterilization or not, which is determined by their subsequent growth (or lack thereof) after incubation. Therefore, the concept of "number of experts" and their "qualifications" for ground truth establishment is not directly applicable in this context. The ground truth for biological indicators is based on the biological viability of the spores when subjected to defined sterilization parameters and subsequent incubation.

4. Adjudication Method for the Test Set

Not applicable for this type of device. The outcome (fluorescence or lack thereof, and correlation to 7-day visual readout) is an objective, measurable endpoint based on biological processes, not subjective human assessment requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic or screening devices where human readers interpret medical images or data, and an AI system may assist or replace them.
• The device in question is a biological indicator and a readout accessory for monitoring sterilization, not a diagnostic tool for human interpretation.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done for the device elements. The "Summary of a Comparative Validation of the BCR-30-min BI™" and subsequent sections detailing the RBIP-ST30™'s characteristics describe the performance of the biological indicator and its readout accessory in isolation as parts of the system.
• The performance of the BI was tested against industry standards and guidance, and the readout accessory's functionality was detailed. The entire system (BI + readout accessory) then provides the final result automatically. The "algorithm" here is the automated processing and fluorescence detection by the RBIP-ST30™, which is performed "standalone" without human intervention for result interpretation.

7. Type of Ground Truth Used

The ground truth used is primarily biological viability/non-viability of the Geobacillus stearothermophilus spores after exposure to sterilization conditions. This is directly assessed by:

• Delayed Growth (7-day visual readout): The conventional method, where lack of growth after 7 days indicates successful sterilization (spores killed). The new device's rapid fluorescence result is correlated to this established 7-day method.
• Resistance Characteristics: Objective measurements like D-value, Z-value, survival time, and kill time, which are universally accepted metrics for BI performance.

8. Sample Size for the Training Set

• The document does not explicitly mention a distinct "training set" sample size. This suggests that a machine learning model, which typically requires a separate training set, may not be the primary component of this device.
• The device's function is based on detecting fluorescence as an indicator of spore germination. This is likely based on established biochemical principles and calibrated thresholds, rather than being "trained" on a large dataset of results. Thus, the concept of a "training set" in the context of predictive algorithms is not directly applicable here. The development would involve robust calibration and validation rather than a training/test split.

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

• Since a distinct "training set" in the machine learning sense is not described, the ground truth establishment method for such a set is also not applicable or described.
• The "ground truth" for calibrating the device would be the known sterilization outcome (spore kill or survival) determined by traditional microbiological methods (e.g., 7-day visual growth after exposure to calibrated sterilization cycles with known efficacy). The device's fluorescence detection system would then be calibrated to correlate with these known outcomes.

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