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The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.

The Belimed Steam Sterilizers MST-H, models 9-6-9, 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 available in a carriage loader and a ground loader (GR) version.

The sterilizers are equipped with Prevacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles.

The Belimed Steam Sterilizers TOP 5000 are equipped with the following predefined cycles (Table 2):

The provided text describes the Belimed Steam Sterilizer MST-H TOP 5000 and its equivalency to a predicate device, focusing on non-clinical performance and a summary of performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the sterilizer are demonstrated by meeting the requirements of ANSI/AAMI ST8:2013. The reported device performance is described for specific cycles.

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

The document does not explicitly state the specific "sample size" in terms of number of sterilization cycles or tests performed for the verification studies. It mentions that the sterilizer was "validated to meet the requirements of ANSI/AAMI ST8:2013." The data provenance is implied to be from the manufacturer's own internal testing ("Belimed validates its sterilization cycles... Prior to release, Belimed Steam Sterilizer MST-H were validated..."). It is a retrospective summary of testing that has already occurred. The country of origin of the data is not specified directly, but the manufacturer (Belimed AG) is based in Switzerland and has a U.S. agent.

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

This information is not provided in the document. The "ground truth" for a steam sterilizer's performance is typically established through adherence to recognized consensus standards like ANSI/AAMI ST8:2013, which outline methodologies for testing and defining effective sterilization. The document does not describe a process involving human expert review of test results for ground truth establishment beyond meeting the standard's requirements.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the testing is for steam sterilizer efficacy, it's unlikely to involve traditional adjudication methods like 2+1 or 3+1 typically used for diagnostic AI devices. The "adjudication" would be based on whether the physical and biological indicators used in the validation tests meet the pass criteria defined by the relevant standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a steam sterilizer, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC comparative effectiveness study is not relevant to its evaluation.

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

The performance described is inherently standalone in terms of the device's function. The "device performance" refers to the sterilizer's ability to sterilize materials according to pre-programmed cycles and validated parameters, without human intervention in the sterilization process itself (beyond loading and selecting the cycle). The validation studies assess the sterilizer's function alone against the defined standards.

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

The ground truth used for assessing the sterilizer's performance is based on scientific and engineering principles, and adherence to recognized consensus standards. Specifically, the ground truth for sterilization efficacy is established by:

• Sterility Assurance Level (SAL) of at least 10^-6: A microbiological standard indicating a probability of one in a million chance of a non-sterile unit.
• Time-at-temperature sufficient to produce an F0 of at least 12 minutes: A measure of the lethality of the steam sterilization process.
• Moisture retention of less than 20% increase in pre-sterilization weight of the towel: A physical parameter indicating effective drying.
• Absence of wet spots on the outer wrapper: A visual indicator of effective drying.

These are objective, measurable criteria defined by standards like ANSI/AAMI ST8:2013 and verified through physical and biological indicator testing.

8. The Sample Size for the Training Set

Not applicable. This device is a traditional medical device (steam sterilizer), not an AI/ML-based device that requires a "training set" in the context of machine learning. The "training" for such a device would refer to its design and engineering to meet specific operational parameters, not data-driven learning.

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

Not applicable. As stated above, this device does not utilize a training set in the AI/ML sense.

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