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The Belimed Steam Sterilizer MST-H TOP 5000 models 9-6-9 HS1, 9-6-12 HS1, 9-6-12 HS1, 9-6-15 HS1, 9-6-15 HS2, 9-6-18 HS1, 9-6-18 HS2, GR 9-6-9 HS1, GR 9-6-12 HS1, GR 9-6-12 HS1, GR 9-6-15 HS1, GR 9-6-15 HS2, GR 9-6-18 HS1, and GR 9-6-18 HS2 are designed for the sterilization of non-porous and porous heat and moisture stable materials used in healthcare facilities.

The Belimed Steam Sterilizers MST-H TOP 5000, 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 BowieDick Test cycles.

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

Here's a breakdown of the acceptance criteria and study information for the Belimed Steam Sterilizer MST-H TOP 5000, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set:
  • Biological Performance Tests: For the "PreVac 270F 4S / 30Dry, 25 lbs wrapped instrument PCD," it states "Full cycle / 3 runs." For the "PreVac 270F 4S / 25 lbs wrapped instrument PCD," it states "Full cycle / 3 runs" and "Half cycle 2 minutes / 3 runs." This indicates a total of 9 runs for the biological performance tests (3 for the 30Dry full cycle, 3 for the 25lb full cycle, and 3 for the 25lb half cycle).
  • Physical Performance Test: The "Chamber temperature profile" test mentions "with empty chamber," but does not explicitly state the number of runs or specific sample size beyond that.
• Data Provenance: Not explicitly stated. The document refers to "non-clinical testing" and the standards it complies with (ANSI AAMI ST8:2013, ANSI/AAMI/ISO 11138-3, ANSI/AAMI/ISO 14161). This suggests the data was generated through laboratory testing, likely by the manufacturer, in accordance with these U.S. and international standards. It does not provide information about country of origin of the data beyond "Belimed AG" being in Switzerland, or if it was retrospective or prospective.

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

This information is not provided in the document. The tests performed are objective, performance-based tests against established standards for sterilization efficacy and temperature profiles. The "ground truth" here is the pass/fail criteria defined by these standards, not expert evaluation of subjective data.

4. Adjudication Method for the Test Set

This information is not applicable/not provided in the context of these objective, performance-based tests. Adjudication methods like "2+1" or "3+1" are typically used for subjective evaluations (e.g., medical image interpretation) where multiple experts assess the same data and discrepancies need to be resolved. For device performance testing against defined metrics, the results are direct measurements compared to acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiologists reading images) and would assess the impact of AI assistance on human performance. The device described is a steam sterilizer, which does not involve human interpretation in its operational performance.

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

Yes, a standalone performance study was done. The performance tests ("Biological Performance Tests" and "Physical Performance Test") evaluate the sterilizer's function itself (algorithm only, if one considers the sterilizer's programmed cycles as an algorithm). There is no "human-in-the-loop" aspect to the sterilizer's core function of sterilization during these tests.

7. The Type of Ground Truth Used

The ground truth used for the performance tests is based on defined performance standards and scientific parameters for sterilization efficacy and physical characteristics.

• For biological performance, the ground truth involves achieving a Sterility Assurance Level (SAL) of 10^-6 and a time-at-temperature (F0) of at least 12 minutes by half cycle, along with specific moisture retention percentages. These are objective, measurable outcomes derived from scientific principles of sterilization.
• For physical performance, the ground truth is the chamber temperature profile being within a specific range (+3°C / +6°F and -0°C / -0°F of the target temperature).

These are not based on expert consensus, pathology, or outcomes data in the typical medical diagnostic sense, but rather on engineering and microbiological performance standards.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a steam sterilizer, a medical device with pre-programmed cycles and physical components, not an AI or machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a device primarily involves its design, engineering, and adherence to established manufacturing and performance standards.

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

This information is not applicable/not provided for the same reasons as point 8. The "ground truth" for the development of such a device stems from engineering specifications, regulatory standards (e.g., ANSI/AAMI ST8:2013), and validated sterilization principles rather than a labeled dataset used to train an AI model.

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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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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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