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The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment in a hot water bath at 160° - 170° F for 30 minutes.

The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are used for the cleaning and high-level disinfection of reusable and disposable breathing circuit parts used in Respiratory Therapy and Anesthesia. Pasteurization kills pathogenic vegetative bacteria and viruses by immersion in water at 160° - 170° F for 30 minutes. Full immersion pasteurization has been identified by the Centers for Disease Control as suitable for high-level disinfection of all parts not used subcutaneously.

The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are identical systems with the exception of the heater capacity. The Pasteurmatic 3000 has three 3,000 watt heaters for a system capacity of 9,000 watts. The Pasteurmatic 3500 has three 5,000 watt heaters for a system capacity of 15,000 watts to allow more rapid heating of the water during the pasteurization cycle when used as a combined washerpasteurizer.

Both systems rotate stainless steel baskets of tubes and parts vertically in a stainless steel tank during both washing and pasteurizing. This forces water through the full length of the tubes and drives out all the air bubbles.

The provided text describes the Olympic Pasteurmatic 3000 and 3500, medical washer-disinfectors, and their substantial equivalence to a predicate device. However, it does not contain a detailed study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, I cannot provide the requested information in the specified format from the provided text. The document states: "Tests were performed to demonstrate that the performance of the Pasteurmatic 3000 and Pasteurmatic 3500 meet or exceed that of the predicate device," but it does not elaborate on what those tests were, what the acceptance criteria for those tests were, or what the reported performance was.

Missing Information:

• Detailed Acceptance Criteria and Performance Table: The document does not specify quantitative acceptance criteria for cleaning or high-level disinfection effectiveness (e.g., specific log reduction of microorganisms, cleanliness metrics). It only states the intended use involves "killing vegetative bacteria and viruses in a hot water bath at 160°-170°F for 30 minutes."
• Sample Size and Data Provenance: No information on sample sizes for test sets or data provenance (country, retrospective/prospective).
• Ground Truth Establishment (Experts, Adjudication, Qualifications): No mention of experts, ground truth establishment methods, or adjudication. This kind of information is typically relevant for interpretative devices (e.g., AI in radiology), not for a physical disinfection device.
• MRMC Comparative Effectiveness Study: No such study is mentioned as the device is a physical disinfector, not an AI-assisted diagnostic tool.
• Standalone Performance Study: No detailed standalone performance study is explicitly described with results. The statement "Tests were performed to demonstrate that the performance... meet or exceed that of the predicate device" implies such tests were done, but the details are absent.
• Type of Ground Truth: Not applicable in the context of the provided information about this device.
• Training Set Information: Not applicable as this is a physical device, not an AI/machine learning model.

Given the nature of the device (medical washer-disinfector) and the content of the 510(k) summary, the standard format for reporting AI/diagnostic device studies does not directly apply here. The 510(k) pathway primarily relies on demonstrating substantial equivalence to an already legally marketed device (the predicate device) through functional and performance comparisons, rather than extensive de novo clinical trials with specific statistical endpoints often seen for novel diagnostic or AI devices.

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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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