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The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version. The sterilizers are equipped with Pre-vacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles.

The provided document describes the Belimed Steam Sterilizer MST-H, not an AI-powered device. Therefore, the questions related to AI-specific criteria (such as effect size of human readers with AI assistance, standalone algorithm performance, number of experts for ground truth, training set information, or a multi-reader, multi-case study) are not applicable.

The document details the acceptance criteria (performance requirements) for the steam sterilizer and summarizes the studies proving it meets these criteria through non-clinical validation.

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

The document presents performance criteria and verified results implicitly throughout the "EFFECTIVENESS" and "NONCLINICAL COMPARISON TO PREDICATE DEVICE" sections by referencing compliance with ANSI/AAMI ST8:2013 and specific outcomes. Here's a structured table:

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

The information provided does not specify a "test set" in the context of individual patient data or medical images, as this is a steam sterilizer for heat and moisture-stable materials, not a diagnostic or AI device.

Instead, the "test set" refers to the tested load configurations and biological indicator runs:

• Sample Size: Not explicitly quantified as a single number, but refers to "validation loads," "single fabric test pack," "full load fabrics," "full load instruments trays (25lbs each)," "Bowie-Dick Test Pack," and "liquids in 1000ml in vented containers" (including "3 bottles" and "full load liquids"). The number of cycles performed for each validation is not specified in detail (e.g., "All PreVac 270 cycles were verified...").
• Data Provenance: The studies were part of the device's premarket notification, implying they were conducted by or on behalf of the manufacturer (Belimed Sauter AG, based in Switzerland). The testing was done to meet U.S. FDA requirements and U.S. standards (ANSI/AAMI). The nature of the testing is prospective validation of the device's performance against established standards.

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 question is not applicable. For a steam sterilizer, "ground truth" is established by direct measurement of physical parameters (temperature, pressure, time) and the observed biological outcome (kill of biological indicators) as defined by established standards (e.g., AAMI ST8:2013). There is no "expert consensus" on diagnostic interpretations or image analysis. The "experts" involved would be microbiologists, engineers, and quality assurance personnel following standardized protocols.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human interpretive tasks (e.g., medical image reading) where disagreement among experts is possible. For a steam sterilizer, compliance is determined by objective physical and biological measurements against predefined criteria in standards.

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. The device is a steam sterilizer and does not involve human readers or AI assistance.

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

This question is not applicable. The device is a steam sterilizer, not an algorithm.

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

The "ground truth" for the steam sterilizer's performance is established by:

• Biological Indicators: Achievement of a Sterility Assurance Level (SAL) of 10⁻⁶ reduction, meaning no growth from biological indicators after exposure to the sterilization cycle. This is a direct measure of microbial inactivation.
• Physical Measurements: Verification of appropriate temperature and pressure profiles throughout the sterilization chamber during cycles, ensuring steady-state thermal conditions and proper air removal (Bowie-Dick test).
• Moisture Retention: Quantitative measurement of weight increase in test loads and visual inspection for wet spots to ensure adequate drying.
• Compliance with Standards: The ultimate "ground truth" is adherence to the specified performance requirements laid out in recognized national and international standards, primarily ANSI/AAMI ST8:2013.

8. The sample size for the training set

This question is not applicable. The device is a physical product (steam sterilizer), not a machine learning model; therefore, it does not have a "training set" in the AI sense. Its design and performance are based on engineering principles and validated through physical and biological testing.

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

This question is not applicable, as there is no "training set" for this device.

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