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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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