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The Belimed Steam Sterilizer TOP 5000, model 5-5-9, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).

The Belimed Steam Sterilizer TOP5000 model 5-5-9 is available as a single door prevacuum or a double door prevacuum version.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 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 4 -- 8.

The smaller Chamber size incorporates additional flexibility, in comparison to Series 4 -8, and allows to operate the sterilizer in an economical way.

Motorized or manually operated vertical door movement leads to an optimal compact design, and allows the operation of the sterilizer, where space is limited.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is offered in the following size configurations:

21″x 21″ x 38″ (535 mm x 535 mm x 965 mm) Single Door, Prevacuum 21"x 21″ x 38″ (535 mm x 535 mm x 965 mm) Double Door, Prevacuum

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 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.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 are factory equipped with cycles which has been tested in accordance with AAMI/ANSI ST-8:2001 under defined load conditions.

The provided document is a 510(k) Special Summary for a medical device called the "Belimed Steam Sterilizer TOP 5000 Model 5-5-9." This document focuses on demonstrating the substantial equivalence of the new model to a predicate device (Belimed Steam Sterilizer TOP 5000 Series 4-8) by highlighting minor modifications and verifying that the device still meets established sterilization standards.

However, the document does not describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the way one would typically define these terms for an AI/ML medical device.

Instead, the "effectiveness" section describes the validation of sterilization cycles based on industry standards, ensuring the sterilizer functions as intended for its core purpose. The "acceptance criteria" here refer to achieving specific sterility assurance levels and performance metrics outlined in these standards, rather than the performance of an AI algorithm with metrics like sensitivity or specificity.

Therefore, many of the requested fields are not applicable to the information provided in this regulatory submission for a steam sterilizer.

Here's an attempt to address the request based on the available information, noting where information is not relevant or not present:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The device in question, the Belimed Steam Sterilizer TOP 5000 Model 5-5-9, is a steam sterilizer and not an AI/ML-driven device. As such, the "acceptance criteria" and "study" described in the document relate to the validation of its physical sterilization capabilities against established industry standards rather than the performance of an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

• Demonstrated a sterility assurance level (SAL) of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle.
• Moisture retention: less than 3% increase in pre-sterilization test pack weight.
• Exhibited no wet spots. |
  | PREVAC cycles (Full Load Instrument Trays) acc. AAMI/ANSI-ST8:2001 Section 5.5.4 | - Qualified according to section 5.5.4 of ANSI/AAMI-ST8:2001.
• Demonstrated a SAL of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle.
• Moisture retention: less than 20% increase in pre-sterilization weight of the towel.
• Exhibited no wet spots on the outer wrapper. |
  | FLASH cycles (Unwrapped Instrument Tray) acc. AAMI/ANSI-ST8:2001 Section 5.5.5.1 and ANSI/AAMI ST37:1996 Section 7.7.3 | - Qualified according to the specified sections.
• Demonstrated a SAL of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle.
• Exhibited no wet spots. |
  | LIQUID cycles (Three 1'000 ml flasks) acc. AAMI/ANSI-ST8:2001 Section 5.5.3 | - Qualified according to section 5.5.3.5.
• Demonstrated a SAL of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle.
• Water loss: not exceeding 50 ml.
• Automatic sealing of the flask closure.
• Temperature of 121°C achieved and maintained in the liquid for at least 12 minutes. |
  | Bowie-Dick (BD) cycle acc. AAMI/ANSI-ST8 Section 5.6 | - Verified using the Bowie-Dick Test Pack.
• Demonstrated a uniform color change throughout the test sheet. |
  | Software Validation | - Performed according to FDA's moderate level of concern recommendations in "Guidance for the Content for Pre-market Submissions for Software Contained in Medical Devices (May 2005)".
• The technology includes microprocessor controller safeguards that abort the cycle and provide signals/warnings for unmet conditions or malfunctions. |
  | Safety and Performance Requirements | - Designed, constructed, and tested to meet UL 61010A-1:2002, UL 61010A-2-041:2002, CSA C22.2 No. 1010-1 (IEC61010-1.2001), and ASME Section VIII, Division 1 for unfired pressure vessels: 2004. |

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

• Test Set Description: The "test set" in this context refers to the defined load conditions and biological indicators used during the validation experiments.
• Sample Size: The document does not explicitly state the number of validation runs or specific biological indicators used for each cycle. It mentions using a "fabric test pack," "full load instruments trays," "unwrapped instrument tray," and "three 1'000 ml flasks."
• Data Provenance: The studies were conducted by SAUTER AG to validate its sterilization cycles using recommended practices, standards, and guidelines developed by organizations such as AAMI. The origin is Switzerland (Sauter AG). The studies are inherently "prospective" in the sense that they were conducted to validate the new device.

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

• Not Applicable. The "ground truth" for a sterilizer is defined by scientific principles of sterilization (e.g., complete kill of biological indicators, achieving specific F₀ values, temperature profiles) and adherence to recognized industry standards (like AAMI/ANSI ST-8:2001). This doesn't involve human expert consensus in the way an AI/ML diagnosis would.

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

• Not Applicable. Adjudication methods like 2+1 are used for reconciling expert disagreements in AI/ML model ground truth establishment. This is not relevant for a sterilizer validation.

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 steam sterilizer, not a device involving human readers or AI assistance in interpretation.

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

• Partially Applicable (in a different sense): The device (sterilizer) operates in a standalone manner according to its programmed cycles. Its "performance" is assessed directly against the physical and biological outcomes of sterilization, without human intervention in the sterilization process itself once initiated. The software validation was done independently against FDA guidance, representing an assessment of the algorithm (software logic) on its own.

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

• The ground truth for the sterilizer's effectiveness is established through:
  • Biological Indicators: Demonstrated complete kill of biological indicators.
  • Physical Parameters: Achievement of specific time-at-temperature sufficient to produce a required F₀ (e.g., F₀ of at least 12 by ½ cycle).
  • Moisture Retention: Specific limits for moisture increase (e.g.,

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