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The Belimed Steam Sterilizer MST-V 3-3-6 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities ... The Belimed Steam Sterilizer MST-V 3-3-6 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).

The Belimed Steam Sterlilzers MST-V 3-3-6 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer Model 5-5-9. The small chamber size incorporates flexibility, and allows operating the sterilizers in the limited space conditions. The Belimed Steam Sterilizer MST-V 3-3-6 is designed to be used for the thermal sterilization of porous and non-porous, heat and moisture stabile materials in the healthcare facilities. Depending of the chosen cycle materials as different as textiles, unwrapped or wrapped instrument trays can be sterilized. The Belimed Steam Sterilizer MST-V 3-3-6 is factory equipped with cycles which have been tested in accordance with AAMI/ANS ST8:2008 under defined load conditions. The predicate device with a chamber volume 73 I has been validated previously.

The provided 510(k) summary describes a steam sterilizer, a device that does not typically involve AI/ML technology, human readers, or image interpretation. Therefore, many of the requested categories in your prompt are not applicable to this type of device submission.

However, I can extract the acceptance criteria and the summary of the studies performed to demonstrate the device meets these criteria.

1. Table of Acceptance Criteria and Reported Device Performance

• Empty Chamber Testing (PreVac, PreVac Flash, Gravity cycles): Demonstrated the sterilizer's capability to provide steady-state thermal conditions and sterility assurance level within the chamber corresponding to predicted tooling (Section 5.4.2.5 of ANSI/AAMI ST8).
• PreVac Cycles with Fabric Test Pack: Achieved a sterility assurance level of at least 10⁻⁶ through time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle, moisture retention of less than 3% increase in pre-sterilization test pack weight, and exhibited no wet spots (Section 5.5.2.5 ANSI/AAMI ST8).
• PreVac Cycles with Full Load Instruments Trays: Achieved a sterility assurance level of at least 10⁻⁶ through time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle, moisture retention of less than 20% increase in pre-sterilization weight, and exhibited no wet spots on the outer wrapper (Section 5.5.4 of ANSI/AAMI ST8).
• Flash Cycles (Unwrapped or Single Wrapped Instrument Trays): Achieved a sterility assurance level of at least 10⁻⁶ through time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle (Section 5.5.5.2 AAMI/ANSI ST8:2008 and ANSI/AAMI ST79:2006 section 10.7).
• Gravity Cycles (Unwrapped Instrument Tray): Achieved a sterility assurance level of at least 10⁻⁶ through time-at-temperature sufficient to produce an Fo of at least 12 minutes by half cycle (Section 5.5.5.1 AAMI/ANSI ST8:2008). |
  | Bowie-Dick Test Pack Performance: Attainment of a uniform color change throughout the test sheet and the normal minimum pressure phase (Section 5.6 of AAMI/ANSI ST8). | Achieved: The Bowie-Dick Test cycle was verified, attaining the required color change throughout the test sheet and normal minimum pressure phase, and exposure temperature within 70 seconds (Section 5.6 of AAMI/ANSI ST8). |
  | Software Validation: Performed according to FDA's moderate level of concern recommendations. | Achieved: Software validation for cycle operation was performed according to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 2005)" recommendations. |
  | Safety and Performance Requirements: Compliance with relevant safety standards (UL 61010-1:2005, IEC EN 61010-2-040:2005, IEC EN 60601-1-2:2001 +A1:2006, IEC EN 62304:2006, ASME Section VIII, Division 1, EN ISO 14971:2007). | Achieved: The device has been designed, constructed, and tested to meet the mentioned safety and performance requirements. |
  | Quality Management System: Certified according to ISO 9001 and ISO 13485. | Achieved: Belimed has a certified quality management system according to ISO 9001 and ISO 13485. |

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

• Sample Size: The document does not specify a numerical sample size for the "test set" in terms of number of sterilizer cycles or biological indicator runs. Instead, it refers to qualification studies conducted "as described in" various sections of the AAMI/ANSI ST8:2008 and ST79:2006 standards. These standards typically outline the protocols for validation, which involve performing a sufficient number of cycles to demonstrate reproducibility and efficacy.
• Data Provenance: The studies were conducted by Belimed Sauter AG, likely at their facilities in Switzerland (given the submitter's address). The data is presumably prospective, as it describes verification studies performed specifically for this device model. The regulatory standards (AAMI/ANSI) are international, though the submission is for the US market.

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

• This information is not applicable. The "ground truth" for a steam sterilizer's performance is objective - the complete kill of biological indicators and the achievement of a specific Sterility Assurance Level (SAL) confirmed through laboratory testing and physical measurements (e.g., temperature, pressure, time). It does not involve expert interpretation or consensus in the context of medical imaging or diagnostic devices.

4. Adjudication Method for the Test Set

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or expert reviewers, typically in diagnostic studies. The evaluation of a sterilizer's performance is based on quantifiable physical and biological outcomes, not subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC or comparative effectiveness study involving human readers with or without AI assistance was done. This type of study is irrelevant for a steam sterilizer device.

6. Standalone (Algorithm Only) Performance

• No standalone algorithm performance study was done. This device is a physical sterilizer, not an AI algorithm. Its "performance" is its ability to effectively sterilize materials, not to produce diagnostic outputs. While it does have "software validation," this refers to the control system's proper functioning, not a diagnostic algorithm.

7. Type of Ground Truth Used

• The ground truth used for validating the sterilizer's performance is:
  • Biological Indicators: Complete kill of robust test organisms (e.g., bacterial spores like Geobacillus stearothermophilus) used in biological indicator preparations.
  • Physical Parameters: Achievement and maintenance of specific temperature, pressure, and time conditions within the sterilizer chamber.
  • Chemical Indicators: Proper color changes or responses of chemical indicators and Bowie-Dick test packs.
  • Moisture Retention: Measurement of moisture content in test packs post-sterilization.
  • These are objective, measurable outcomes in accordance with established sterilization standards (AAMI/ANSI).

8. Sample Size for the Training Set

• This device does not involve a "training set" in the context of AI/ML. The sterilizer's design and factory-programmed cycles are developed based on engineering principles and established sterilization science, not by training a model on a dataset. The "validation" performed is more akin to verification and performance testing against predetermined standards.

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

• Not applicable, as there is no "training set" for this device. The physical and biological ground truths described in point 7 are used for validation and verification, not for training a machine learning model.

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The Belimed Steam Sterilizer TOP 5000, Series 8, model 6-0-12 is designed for sterilization of nonporous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 Series 8, model 6-0-12, is equipped with the following factoryprogrammed Sterilization cycles and values (Tables 1-3).

The Belimed Steam Sterilizer TOP 5000 Series 8 is intended for use in hospital and health care facilities.

The provided document describes a medical device (Belimed Steam Sterilizer TOP 5000 Series 8) and its validation, rather than an AI-powered medical device. Therefore, several of the requested categories (e.g., sample size for AI test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable.

However, I can extract the acceptance criteria and the study results that demonstrate the device's effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for sterilizers are based on achieving a sterility assurance level (SAL) of at least 10⁻⁶ and specific physical parameters. The reported performance indicates that the device met these criteria through various validation studies aligned with AAMI/ANSI-ST8:2001.

The study that proves the device meets the acceptance criteria is detailed under the "Effectiveness" section of the 510(k) summary. Belimed Sauter AG validated its sterilization cycles by recommended practices, standards, and guidelines developed by various independent organizations, specifically the Association for the Advancement of Medical Instrumentation (AAMI).

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

• Sample Size: The document does not specify a numerical sample size for the test sets (e.g., number of fabric packs, instrument trays, or liquid flasks tested). It describes testing using "fabric test packs," "full load instrument trays," "unwrapped instrument tray," and "three 1000 ml flasks." The implication is that these tests were conducted sufficiently to meet the AAMI/ANSI-ST8:2001 requirements.
• Data Provenance: The studies were conducted by Belimed Sauter AG, the manufacturer, as part of their pre-market submission to the FDA. The country of origin for the data is not explicitly stated, but Belimed Sauter AG is identified as Belimed, Inc.'s US Agent, and the device is intended for use in "hospital and health care facilities" (presumably in the US, given the FDA filing). The studies are prospective in nature, as they are qualification/validation tests performed to demonstrate the device's effectiveness before market release.

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)

Not applicable. The ground truth for sterilizer effectiveness is established through objective physical and microbiological measurements (e.g., F₀ values, temperature logs, biological indicators, moisture retention, color change on test sheets) against predefined standards, not through expert human interpretation in the sense of image analysis or diagnostic assessment.

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

Not applicable. As described above, the validation is based on objective measurements against engineering and microbiological standards, rather than human expert adjudication.

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

Not applicable. This is a sterilizer, not an AI-powered diagnostic device involving human readers.

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

This question is not directly applicable in the context of a sterilizer. However, the entirety of the sterilization validation study can be considered "standalone" performance in that it demonstrates the device's ability to sterilize materials independently, according to its programmed cycles, without human intervention during the active sterilization process itself. The "algorithm" here refers to the pre-programmed sterilization cycles and control software.

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

The ground truth used for sterilizer validation is objective and based on established scientific principles and industry standards for sterilization. This includes:

• Microbiological Confirmation: Achieving a Sterility Assurance Level (SAL) of at least 10⁻⁶, often inferred from F₀ values (which relate to the equivalent time at a reference temperature required to kill a population of microorganisms).
• Physical Parameters: Verification of specific temperature, pressure, and time profiles within the sterilizer chamber and load.
• Biological Indicators: Although not explicitly detailed for every test, biological indicators are typically used to confirm the kill of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) for SAL determination.
• Chemical Indicators: Color changes on chemical indicators (like the Bowie-Dick test) demonstrate uniform steam penetration.
• Moisture Retention: Quantitative measurement of moisture remaining on sterilized items to ensure effective drying.

These are quantitative, empirical measures derived from standard testing methodologies rather than subjective expert consensus or pathology.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set" in the AI sense. The device's design and factory-programmed cycles were developed through engineering and scientific principles, not by training on a dataset.

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

Not applicable, as there is no "training set" for this type of device. The "ground truth" for the device's design and operation reflects established scientific principles of sterilization and adherence to relevant industry standards (e.g., AAMI/ANSI-ST8:2001).

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The Belimed Steam Sterilizer TOP 5000, series 24, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizers TOP 5000 Series 24 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer TOP 5000 series 9 - 18.

The larger chamber size (higher chamber) incorporates additional flexibility, and allows operating the sterilizers in an economical way (less floor space required).

The Belimed Steam Sterilizer TOP 5000 Series 24 is designed to be used for the terminal Sterilization of porous and non porous, heat and moisture stabile materials in the healthcare facilities.

Depending of the chosen cycle materials as different as textiles, glassware, unwrapped or wrapped instrument trays with single or multiple instruments may be sterilized.

The provided document describes the Belimed Steam Sterilizer TOP 5000 Series 24, a Class II medical device, and its acceptance criteria as documented in a 510(k) premarket notification. The device is a "Steam Sterilizer" regulated under 21 CFR 880.6880, product code FLE.

The submission focuses on demonstrating substantial equivalence to predicate devices (Belimed Steam Sterilizer TOP 5000 Series 9-18, K021223, and Series 4-8, K033538). The primary modifications from the predicate device are a larger chamber size, increased vacuum-pump power to accommodate the larger volume, and improved functionality (inherited from Series 4-8).

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Belimed Steam Sterilizer TOP 5000 Series 24 are based on its ability to achieve sterility assurance levels (SAL) and meet specific performance characteristics as outlined in recognized standards. The study demonstrates that the sterilizer performs as intended by meeting these criteria across various cycles and load types.

• FLASH cycles: Demonstrated a sterility assurance level of at least 10^-6 through achievement of a time-at-temperature sufficient to produce an F0 of at least 12 by half cycle.
• LIQUID cycles: Demonstrated a sterility assurance level of at least 10^-6 through achievement of a time-at-temperature sufficient to produce an F0 of at least 12 by half cycle. |
  | Moisture Retention (PREVAC - Fabric) | Moisture retention of less than 3% increase in pre-sterilization test pack weight, and no wet spots. | Achieved moisture retention of less than 3% increase in pre-sterilization test pack weight, and exhibited no wet spots (for PREVAC cycles verified using the fabric test pack). |
  | Moisture Retention (PREVAC - Instruments) | Moisture retention of less than 20% increase in pre-sterilization weight of the towel, and no wet spots on the outer wrapper. | Achieved moisture retention of less than 20% increase in pre-sterilization weight of the towel, and exhibited no wet spots on the outer wrapper (for PREVAC cycles verified using full load instrument trays). |
  | Wet Spots (FLASH cycles) | No wet spots. | Exhibited no wet spots (for FLASH cycles). |
  | Water Loss (LIQUID cycles) | Water loss not exceeding 50 ml. | Achieved a water loss not exceeding 50 ml (for LIQUID cycles). |
  | Temperature Maintenance (LIQUID cycles)| Automatic temperature of 121°C achieved and maintained in the center of the liquid for at least 12 minutes. | Automatic temperature of 121°C was achieved and maintained in the center of the liquid for at least 12 minutes (for LIQUID cycles). |
  | Bowie-Dick Test Pack | Uniform color change throughout the test sheet. | Demonstrated a uniform color change throughout the test sheet (for Bowie-Dick Test Pack verification). |

Study Proving Device Meets Acceptance Criteria

The study was a nonclinical comparison and validation study against recognized consensus standards.

2. Sample size used for the test set and data provenance:

   • The document implies that the "test set" consisted of various sterilization cycles and load types (e.g., fabric test pack, full load instrument trays, unwrapped instrument trays, 1000 ml flasks of liquid) run within the Belimed Steam Sterilizer TOP 5000 Series 24.
   • The sample size for each test (e.g., number of runs for each cycle type) is not explicitly stated but is implicit in the "validation" process.
   • The data provenance is prospective internal validation data performed by Belimed Sauter AG. The validation was conducted in accordance with AAMI/ANSI ST-8:2001 and ANSI/AAMI ST37:1996. The document does not specify the country of origin of the data, but the manufacturer is based in Switzerland.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

   • The document does not mention the direct involvement of human experts to establish a "ground truth" for individual test runs in the way typical for AI/diagnostic devices. The acceptance criteria themselves, derived from AAMI/ANSI standards, serve as the "ground truth."
   • The "qualifications" of expertise are integrated into the standards themselves, which are developed by organizations like AAMI, comprising experts in sterilization science and practice.

4. Adjudication method for the test set:

   • There was no explicit adjudication method described for individual test results beyond direct comparison to the criteria in the AAMI/ANSI standards. Each test run's performance (e.g., F0 value, moisture retention, wet spots, color change) was measured and directly compared against the established numerical or qualitative thresholds defined by the standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done. This device is a sterilizer, not a diagnostic imaging device involving human readers or AI assistance.

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

   • This is not applicable as the device is a physical sterilizer. The performance evaluated is the sterilizer's function itself, which is inherently "standalone" in its operation relative to the sterilization process. Software validation was performed for the microprocessor controller, but this refers to the control system of the sterilizer, not a standalone diagnostic algorithm.

7. The type of ground truth used:

   • The ground truth used is performance against established industry standards and recommended practices regarding sterilization efficacy. Specifically, the "complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10^-6 reduction." This is often backed by microbiological testing (biological indicators) and physical measurements (temperature, pressure, time, F0 values, moisture, Bowie-Dick test results).

8. The sample size for the training set:

   • This concept is not applicable to this type of device. There isn't a "training set" in the context of an AI/machine learning model. The sterilizer's design and operating parameters are developed through engineering and adherence to established principles, not iterative machine learning from a dataset.

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

   • This question is not applicable for the reasons stated in point 8.

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