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The Miele G 7881 Dental Thermal Disinfector is intended to clean and high-level disinfect heat stable reusable dental instruments and accessories using a thermal process. The cycle parameters for high-level disinfection are 93℃ for 10 minutes. The Miele G7881 Dental Thermal Disinfector also has the following cleaning and high-level disinfection cycles:

The G7881 Dental Thermal Disinfector is a washer/disinfector for aqueous cleaning and simultaneous thermal disinfection of dental instruments and accessories. It operates with three spray arms on three different levels. A powerful circulation pump moves 2.8 gallons of water at a rate of 105 gallons/minute. The specially designed jets on the spray arms spray the water onto the wash load at a low pressure (About 13 psi) to prevent any goods from being washed off the racks.

The complete unit is made of electro-polished stainless steel, the exterior is additionally powder coated. The unit is equipped with a microcomputer control. An integrated water softener ensures consistently high water quality; the steam condenser comes standard and minimizes contaminated aerosols and odor affecting the environment.

Acceptance Criteria and Device Performance for Miele G7881 Dental Thermal Disinfector

Based on the provided 510(k) summary, the device is a Miele G7881 Dental Thermal Disinfector, and the review focuses on its "high-level disinfection" capabilities. The crucial point is that the regulatory submission states that the cycle parameters for high-level disinfection have not been changed from the legally marketed predicate device (Miele G7781 Dental Thermal Disinfector, K950518), and therefore, additional testing was not deemed necessary for these specific parameters.

However, the document does refer to prior studies that support the predicate device's performance.

Here's the breakdown of the information requested:

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: Not explicitly stated for this submission (G7881). The document indicates that since the high-level disinfection cycle parameters were not changed from the predicate device (G7781), additional testing for these parameters was not necessary. The 6-log reduction performance refers to studies conducted for the predicate device (K950518). Information regarding the specific sample size of microorganisms or instruments used in those prior studies is not provided in this document.
• Data Provenance: The document states that "additional testing was done in accordance with German Health Authority guidelines Federal Health Report 1980:23:364-35-65." This suggests the efficacy studies, including the log reduction data, may have originated from Germany and were likely prospective studies designed to validate the disinfection parameters according to those guidelines. (Retrospective vs. Prospective is not explicitly stated, but efficacy studies for device clearance are typically prospective.)

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

This information is not provided in the document. Efficacy studies for disinfection devices typically rely on objective laboratory methods (e.g., culturing microorganisms before and after treatment) rather than expert consensus on subjective assessments.

4. Adjudication Method for the Test Set

This information is not applicable to the type of efficacy testing described (microbiological log reduction). Adjudication methods like "2+1" are typically used for subjectively assessed endpoints (e.g., imaging interpretation).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is not relevant for a device like a thermal disinfector, which performs a physical or chemical process. MRMC studies are typically used to assess the effectiveness of diagnostic tools where human interpretation of data is involved (e.g., radiologists reading images).

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

Yes, in essence. The performance claims are based on the device's ability to achieve specific physical parameters (temperature and time) and its resulting microbiological reduction, independent of human intervention during the disinfection cycle. The device's efficacy is measured intrinsically, not through human interaction with an algorithm.

7. The Type of Ground Truth Used

• Microbiological Efficacy: The primary ground truth for the "high-level disinfection" claim is direct microbiological testing demonstrating a 6-log reduction of an appropriate myco bacterium species. This is an objective, quantitative measure of microbial inactivation.
• Cleaning Efficacy: The claim that it "cleans instruments contaminated with blood, extremely well" implies visual inspection and possibly other objective assessments of residual soil, though specific methods are not detailed.

8. The Sample Size for the Training Set

This information is not provided as the Miele G7881 Dental Thermal Disinfector is not an AI/ML-based device that would typically have a "training set" in the context of machine learning. Its performance is based on engineered physical parameters and validated through microbiological testing.

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

This question is not applicable as the device does not employ machine learning or AI that would require a "training set" with established ground truth in the conventional sense. The "ground truth" for its function (disinfection efficacy) is established through laboratory validation of its physical processes and their biological outcomes.

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