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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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