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The Fisher & Paykel Healthcare MR850 Humidifier is a Respiratory Gas Humidifier as per 73 BTT, 21 CFR §868.5450. It is intended to add moisture to and warm breathing gases for administration to a patient.

The MR850 is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation, positive pressure breathing assistance or general medical gases.

Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. Heat is used to increase the water output of the humidifier. Heated breathing tubes are also utilized in order to increase operating efficiency and reduce excessive water and heat loss.

The MR850 Humidifier is a Respiratory Gas Humidifier (heated passover type) according to 21 CFR 8868,5450. Heat is used to provide an evaporated water content to dry breathing gases. Heated breathing tubes are also utilized in order to increase operating efficiency and reduce excessive water and heat loss.

The MR850 has a thermoplastic enclosure with dimensions of 140mm high × 135mm wide × 173mm deep, and weighs 2.8kg. A heaterplate is positioned in the top of the unit, where the enclosure rim and finger guard allow a humidification chamber to be added. Temperature probe and heater wire connection sockets are on the right side of the unit. A serial data interface port is located in the underside of the unit, with a mounting bracket at the back of the device.

The unit controls and displays are located on the front panel. Controls consist of power, operating mode and alarm mute buttons. A setup / alarm display indicates if a part of the equipment is incorrectly installed, or type of alarm condition occurring.

Accessories for the MR850 Humidification chamidification chambers, breathing circuits, electrical adaptors and temperature / flow probes.

The chamber slides on to the heaterplate and contains the water supply for adding humidity to breathing gases. The breathing circuit transports gases to the patient, and includes sections for connection from ventilator to humidifier, inspiratory limb to the patient, and expiratory limb for return to the ventilator. Heated wires in the inspiratory and expiratory limbs prevent condensation. The electrical adaptor supplies power to the heated wires. The temperature / flow probe has sensors at the chamber and patient airway ends of the inspiratory section for heater control.

The MR850 Humidifier has two operating modes. Intubated Mode is used for patients who have bypassed upper airways, and delivers humidified gas to the patient at 37°C (body temperature). Mask Mode is used for patients receiving breathing gases via a face mask, and delivers humidified gas to the patient at 31°C. The MR850 Humidifier monitors temperature and flow parameters, and equipment integrity, in order to maintain stable performance conditions and notify the user of high delivered temperature, inadequate delivered humidity, or incorrect equipment set-up conditions.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fisher & Paykel MR850 Respiratory Humidifier, formatted as requested.

Acceptance Criteria and Device Performance Study for Fisher & Paykel MR850 Respiratory Humidifier

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): Not explicitly stated in the provided document. The document mentions "clinical verification studies" but does not give specific numbers for patients or cases.
• Data Provenance: Not explicitly stated. The manufacturer is based in New Zealand (Fisher & Paykel Electronics Limited, Auckland, New Zealand), but the location of the clinical verification studies is not specified. It refers to "international and USA medical electrical equipment standards," implying adherence to global standards rather than specifying study location. It is likely prospective as it refers to "clinical verification studies" performed on the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not provided in the document. The studies mentioned are focused on the device's functional performance and safety, not on diagnostic accuracy requiring expert interpretation of results to establish ground truth in the context of, for example, medical imaging.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable / not provided. The clinical verification studies for this humidifier would involve direct measurement of temperature, humidity, and observation of patient tolerance/device interaction, rather than subjective interpretation requiring an adjudication process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks, typically involving AI algorithms. The MR850 is a medical device for humidification, and its performance is assessed against technical specifications and physiological outcomes rather than human reader improvement with AI assistance.

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

• Yes, implicitly. The non-clinical tests (mechanical, electrical, thermal safety, environmental, EMC, functional verification, performance capacity, accuracy) assess the device's standalone performance without human intervention, ensuring it meets technical and safety standards. The "clinical verification studies" also demonstrated the device's ability to "provide required temperature and humidification output" and "had reduced susceptibility to user error factors," indicating its intrinsic performance characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the MR850's performance is based on:
  • Direct physical measurements: Temperature (37°C for intubated, 31°C for mask mode), humidity output, and flow parameters.
  • Compliance with established standards: IEC 60601-1, IEC 60601-1-2, UL 2601-1, mechanical/electrical/environmental testing requirements of the 1993 FDA Reviewer Guidance, ISO 8185, and ASTM F1690.
  • Observed clinical outcomes: "successful use of the humidifier and its ability to provide effective humidity levels," "low level of user intervention and had reduced susceptibility to user error factors," and "did not introduce further hazards to user or patient."

8. The sample size for the training set

• This information is not applicable / not provided. This device is a physical medical device, not an AI algorithm that requires a "training set" in the machine learning sense. Its design and development would involve engineering and testing phases, not data-driven training.

9. How the ground truth for the training set was established

• This information is not applicable / not provided for the same reason as point 8.

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