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The System 2S Steam Sterilizer is designed for efficient, point-of-use sterilization of nonporous and porous, heat and moisture-stabile materials used in outpatient surgery, ambulatory care and urgent care centers. The System 2S Steam Sterilizer is available in one configuration: Prevacuum 16"diameter x 26"length chamber size.

The System 2S Steam Sterilizer is equipped with the following factory-programmed set sterilization cycles and cycle values:

*250°F Cycle can be adjusted from factory-set value of 15 minutes dry time to 30 minutes dry time for instrument trays.

** 270°F Cycle can be adjusted from factory-set value of 30 minutes dry time to 5 minutes dry time for single fabric pack.

The System 2S Steam Sterilizer is a Class II medical device as defined by 21 CFR Part 880.6880. The System 2S Steam Sterilizer is a sliding door sterilizer intended for the terminal sterilization of surgical instruments, various hospital utensils and other surgical materials and supplies to be used for human diagnostic or therapeutic procedures.

The System 2S Steam Sterilizer cycle descriptions are as follows:

• FLASH Cycle is provided for quick turnaround processing of nonporous goods (e.g. dropped instruments) at 270°F (132°C) for 3 minutes sterilize and 1 minute dry;
• GRAVITY Cycle is provided for the sterilization of heat and moisture stabile goods at 250°F (121°C) for 30 minutes sterilize and 15 minutes dry;
• PREVAC Cycle is provided for the sterilization of heat and moisture stabile goods at 270°F (132°C) for 4 minutes sterilize and 30 minutes dry;
• EXPRESS Cycle is offered for rapid processing of single-wrapped instrument trays at 270°F (132°C) for 4 minutes sterilize and 3 minutes dry;
• DART (Bowie-Dick Test) Cycle is provided for verification of effective removal of residual air in the chamber and load during testing. This cycle is pre-programmed and fixed; and
• LEAK Test Cycle is provided for verification of door seal and piping system integrity and is pre-programmed and fixed.

Here's an analysis of the provided text regarding the STERIS System 2S Steam Sterilizer, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in terms of a specific number of independent tests or loads. Instead, it discusses the general approach to validation.

• Sample Size: The text mentions "worst-case loads" and "qualification studies." However, it does not quantify the specific number of test cycles, biological indicators, or different load configurations used during these studies.
• Data Provenance: The studies were conducted by STERIS as part of the development and qualification testing of the System 2S Steam Sterilizer. This implies the data is prospective (generated specifically for the purpose of validating this device) and originates from the STERIS manufacturing facility in Erie, Pennsylvania, which is registered with and regulated by the FDA and certified to ISO 9001.

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

This information is not explicitly provided in the document.

The document states that STERIS "qualifies its recommended sterilization cycles through the application of rigorous performance standards and recommended practices developed by various independent organizations." While this implies expertise, it doesn't detail the involvement of specific experts in establishing the ground truth for this particular device's test set. The performance standards (AAMI, ASME, UL, CSA) themselves were developed by expert committees within those organizations.

4. Adjudication Method for the Test Set

This information is not provided in the document. The document describes a technical evaluation of sterilizer efficacy based on biological indicator kill rates and physical parameter monitoring, rather than a process requiring human adjudication of subjective outcomes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical decision support systems where human readers interpret data, and the effect of AI on their performance is measured. The STERIS System 2S Steam Sterilizer is a medical device for sterilization, not a diagnostic or interpretive AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The concept of "standalone performance" for this device type would refer to the sterilizer's ability to achieve sterilization without external human intervention during the cycle itself, assuming the operator correctly loads the device and selects the appropriate cycle beforehand.

In this context, the entire study of the sterilizer's performance is inherently a standalone performance assessment of the device's function. The effectiveness (killing Bacillus stearothermophilus spores and achieving SAL < 10^-6) is measured directly from the device's output given specific inputs (defined cycles, worst-case loads). Human involvement is in setting up the test, but the performance measured is that of the machine.

7. The Type of Ground Truth Used

The primary ground truth used for effectiveness is:

• Biological Indicators: Specifically, the complete kill of Bacillus stearothermophilus spores. This is a direct biological measure of sterilization efficacy.
• Sterility Assurance Level (SAL): Defined as less than 10^-6, which is a quantitative measure of the probability of a single viable microorganism remaining after sterilization.
• Compliance with Standards: Meeting the requirements of AAMI-ST8 and AAMI-ST37, which are established industry standards for steam sterilization.

For safety, the ground truth is compliance with various national and international safety and pressure vessel codes (UL, CSA, ASME, California Seismic, CRN).

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a traditional mechanical and electrical medical device, not an AI/machine learning system that requires a "training set" in the computational sense. The "training" for such a device is its engineering design, manufacturing processes, and adherence to established physical and biological principles of sterilization.

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

This question is not applicable as there is no "training set" in the context of an AI/ML algorithm. The "ground truth" for the device's design and operation principles are based on well-established scientific principles of moist heat sterilization, industry best practices, and international standards (e.g., AAMI, ASME) that have been developed and refined over many years by experts in sterilization and engineering.

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