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The STERIS Eagle Century Steam Sterilizer is designed for efficient, sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities.

The AMSCO brand Eagle Century Steam Sterilizer is a Class II medical device as defined by 21 CFR §880.6880. The Eagle Century Steam Sterilizer is a sliding door sterilizer, offered in either a prevacuum or gravity configuration, intended for the terminal sterilization of heat and moisture-stabile materials.

The STERIS Eagle Century Steam Sterilizer is a Class II medical device used for the terminal sterilization of heat and moisture-stabile materials.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for sterilization is achieving a Sterility Assurance Level (SAL) of less than 10^-6 (probability of less than one chance out of one million of a non-sterile indicator). The device's performance is reported by demonstrating complete kill of biological indicators and verifying this SAL.

A summary of the device's performance against its intended cycles and loads is provided in the tables below. These tables represent the reported performance as validated by STERIS.

Prevacuum Configuration - Performance Summary

Gravity Configuration - Performance Summary

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 a specific "sample size" for the test set in terms of number of sterilization cycles or tests performed. However, it does refer to "Validation Studies" which imply testing was conducted.

The data provenance is presented as internal validation studies conducted by STERIS Corporation to comply with U.S. standards (AAMI-ST8 and AAMI-ST37). This suggests the data is retrospective as it has been collected and analyzed for submission. The country of origin for the data is implicitly the United States, given the reference to U.S. standards and the company's location.

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)

The document does not specify the number or qualifications of individual experts. However, it states that STERIS "validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI)." This indicates that the "ground truth" (the definition of effective sterilization) is established by widely recognized industry standards and guidance, rather than by a specific panel of individual experts for this particular submission.

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

The document does not describe an adjudication method for the test set. The validation process relies on meeting established benchmarks (complete kill of biological indicators and SAL < 10^-6) as defined by AAMI standards, rather than expert consensus on individual test results.

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

This question is not applicable to the provided document. The device is a steam sterilizer, not an AI-assisted diagnostic or imaging tool involving "human readers" or "cases" in the medical imaging sense. The study described is a device validation study, not a comparative effectiveness study involving human interpretation with and without AI.

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

This question is not directly applicable in the typical sense of "standalone AI performance." However, the validation studies described are effectively "standalone" in the context of the sterilizer's function. The sterilizer operates autonomously through its programmed cycles. Its performance is evaluated based on its ability to achieve sterility without human intervention in the sterilization process itself (beyond loading, selecting cycles, and maintenance). The "algorithm" here refers to the device's internal control system that executes the sterilization cycles. The validation studies demonstrate the efficacy of these programmed cycles.

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

The ground truth for the validation studies is based on:

• Biological Indicators: Demonstrated complete kill of biological indicators (which contain highly resistant bacterial spores).
• Sterility Assurance Level (SAL): Verification of an SAL of less than 10^-6.
• Compliance with Standards: Adherence to recommended practices, standards, and guidelines established by organizations like AAMI (e.g., AAMI-ST8 for hospital sterilizers, AAMI-ST37 for flash sterilization). These standards themselves are derived from extensive scientific research and expert consensus within the field of sterilization.

8. The sample size for the training set

This question is not applicable. The device is a physical steam sterilizer, not a machine learning or AI model that requires a "training set" of data in the computational sense. The design and engineering of the sterilizer would be based on scientific principles and engineering specs, not iterative training on data.

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

This question is not applicable for the same reasons as #8. There is no "training set" for a steam sterilizer in the context of machine learning. The "ground truth" for the device's design and operation principles would be established through established scientific and engineering principles for steam sterilization, regulatory requirements, and industry standards.

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