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The Midas Flowmeter is intended for use as a continuous flow conscious sedation system to deliver a mixture of nitrous oxide and oxygen gases to a patient. When used with the electronic automatic vacuum switch (eAVS), the Midas Flowmeter is used to control the scavenging of waste analgesic gas.

The Midas Flowmeter is used within a healthcare environment during a nitrous oxide (N20)/oxygen (O2) conscious sedation system. The device is a digitally controlled, software driven, continuous flow device that precisely meters nitrous oxide and oxygen medical gases and delivers gas mixtures to a conscious, spontaneously breathing patient. The Midas Flowmeter uses electronic mechanisms to control the flowrate and mixture percentage of gases delivered to a patient. The optional eAVS is an accessory to the Midas Flowmeter. It is used within the nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The eAVS connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The eAVS is specifically designed to work with the Midas Flowmeter and all functionality control of the eAVS has been integrated into the user interface of the Midas Flowmeter.

The provided document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence of a new medical device to existing predicate devices. It primarily discusses comparisons of technical characteristics and compliance with recognized standards.

Crucially, this document does NOT contain explicit acceptance criteria tables or a detailed study report that proves the device meets specific performance metrics in a clinical or simulated environment with ground truth from experts, as would be expected for an AI/ML powered device.

The document states:

• "The characteristics of the Midas Flowmeter and optional eAVS do not require clinical investigation due to safety and efficacy being supported by non-clinical testing performed."
• "The verification and validation testing of the Midas Flowmeter and optional eAVS was found to be acceptable and supports the claims of substantial equivalence."

This indicates that the device's performance was evaluated through bench testing and compliance with recognized consensus standards, rather than a clinical study involving human readers or expert-established ground truth for a test set.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or the type of ground truth used, because such a study (as described in the prompt) was not performed or detailed in this 510(k) submission.

The document focuses on:

• Comparison of Technical Characteristics: Showing the Midas Flowmeter and eAVS are similar in function, intended use, and technology to predicate devices (FlowStar Touch Digital Mixer Flowmeter and Nitronox Scavenger Plus).
• Compliance with Standards: Listing various IEC, ISO, AAMI, and ASTM standards that the device was tested against to demonstrate safety and performance (e.g., IEC 60601-1 for basic safety, ISO 11195 for gas mixers).
• Non-clinical Performance Data (Bench Testing): A bulleted list of "performance bench testing" categories like "Gas Flow Rate Adjustment," "Touchscreen Display," "Accuracies and Faults," and "Life Testing." However, it does not provide the specific acceptance criteria for these tests nor the detailed results in a quantitative manner as requested. It simply states that "The results of the testing demonstrated that the Midas Flowmeter and optional eAVS met all of the acceptance criteria for functional, operational, and performance characteristics..."

In summary, none of the specific elements required to answer your prompt (e.g., table of acceptance criteria with reported performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details) are present in this 510(k) document because the device is a hardware system (a gas mixer) and was cleared based on non-clinical bench testing and adherence to recognized standards, not clinical performance studies with AI/ML components involving human expert review or data-driven ground truth.

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