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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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