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F&P 820 System Humidifier Base:

The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.

This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.

The F&P 820 System is designed for adult and pediatric patients (excluding neonate), requiring a flow range ≥ 5 L/min. It is designed for use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.

F&P 820A10 Breathing Tubes:

The F&P 820 series breathing tubes are an accessory to the F&P 820 System and are compatible with F&P 820 series humidifiers.

The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.

This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.

This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.

F&P MR325 Humidification Chamber:

The MR325 humidification chamber is an accessory to the F&P 820 System and is compatible with F&P 820 series humidifiers.

The F&P 820 System is intended to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases when using a continuous or intermittent ventilator system or a continuous gas flow.

This system is intended for both noninvasive and invasive therapies. The addition of heat and humidity to the supply of cold and dry respiratory gases provided through noninvasive ventilation is beneficial to prevent drying of the patient's airways.

This system is designed for adult and pediatric (excluding neonate) use in hospitals, long term care facilities and homes, under the prescription of qualified medical professionals.

The Fisher & Paykel 820 Humidification (also referred to as F&P 820 System) is designed to provide respiratory humidification by providing heat, humidity, and delivering respiratory gases to patients.

The F&P 820 System is a revision of the predicate device platform, the Fisher & Paykel MR810 Respiratory Humidifier (K143646).

The provided text is a 510(k) Summary for the F&P 820 Humidification System. It describes the device, its intended use, comparison with predicate devices, and the non-clinical testing performed to demonstrate substantial equivalence.

However, the information requested in your prompt regarding acceptance criteria and a study that proves the device meets the acceptance criteria with specific details like sample size, expert ground truth establishment, adjudication methods, MRMC studies, and separate training/test sets with their ground truth establishment for an AI/ML powered device is not present in this document.

This document pertains to a traditional medical device (a respiratory humidifier system), not an AI/ML-powered diagnostic or therapeutic device. Therefore, the detailed acceptance criteria and study design elements typically associated with AI/ML device validation (like sensitivity, specificity, AUC, human reader improvement with AI assistance, sample sizes for training/test sets, and expert consensus for ground truth) are not applicable to this submission and are consequently not described.

The "Performance Data" section (Section VII) focuses on demonstrating compliance with relevant international standards for medical devices (e.g., electrical safety, EMC, biocompatibility, software verification/validation, human factors, and bench/performance testing for humidification output, thermal overshoot, resistance to flow, etc.). These are the "acceptance criteria" for this type of device, and the summary states that the device "meets the applicable requirements" and "demonstrates an appropriate profile."

To directly answer your prompt, based only on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" in the format of a table as you might expect for an AI/ML study (e.g., minimum sensitivity). Instead, it states that the device was tested to "applicable requirements" of various standards, and the performance described is primarily via comparison to the predicate device in Table 1, where the subject device's performance characteristics are presented as meeting or being equivalent to those of the predicate and relevant standards.

Here's an extraction of relevant performance characteristics from Table 1, framed as criteria and performance. Note: These are not explicit "acceptance criteria" numbers as you would see for predictive models, but rather technical specifications and compliance claims.

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