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The Fisher & Paykel MR810 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 system.

The MR810 System is intended for both non-invasive therapies. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through non-invasive or invasive ventilation is beneficial to prevent drying of the patient airways.

The MR810 System is for use for adult and pediatric patients requiring a flow range ≥5 L/min.

The MR810 System is designed for use in hospitals, long term care facilities and homes under the prescription of a qualified medical professional.

The Fisher & Paykel MR810 System is intended to heat and humidify breathing gases and therefore meets the definition of a respiratory gas humidifier in accordance with 21 CFR §868.5450 and the FDA guidance document Heated Humidifier Review Guide.

The MR810 System consists of the following components:

• . MR810 Respiratory Humidifier;
• . Accessories:
  • Breathing circuit (e.g. 900MR810 Adult Single Limb Circuit, 900MR810E o Adult Dual Limb Circuit); and
  • Humidification chamber (e.g. MR370 reusable humidification chamber). O

The MR810 respiratory humidifier is an electrically-powered heat controller which utilizes a microprocessor with embedded software to control the heating elements.

Unconditioned (i.e. cold, dry) gases are delivered to the MR810 System from a gas source (e.g. ventilator) via the dryline component of the breathing circuit. The unconditioned gases are transported to the humidification chamber where they are heated and humidified.

The heated and humidified gases then travel down the inspiratory limb of the breathing circuit. The inspiratory limb of the 900MR810/900MR810E breathing circuits is electrically heated by means of a heaterwire in order to maintain the temperature of the gases. The heater wire is powered by the MR810 respiratory humidifier via a built-in heaterwire adaptor.

When a return flow of expired gases from the patient to the gas source is required, the expired gases are transported via the expiratory limb of the breathing circuit. In other cases, the expired gases from the patient are exhaled into the environment, as per normal, unassisted breathing.

The device described is named "MR810 System", which is a respiratory gas humidifier. This report details the acceptance criteria and the study that proves the device meets those criteria for its expanded indications for use.

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance:

The document describes "bench testing" without specifying a particular sample size (e.g., number of devices tested). The data provenance is not explicitly stated in terms of country of origin of data or retrospective/prospective in the provided text. However, the manufacturer is Fisher & Paykel Healthcare Ltd, based in New Zealand.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

This information is not provided. The study relies on adherence to international standards (ISO and IEC) and internal performance bench testing rather than expert-established ground truths in a clinical context for the device's performance.

4. Adjudication method for the test set:

Not applicable, as the compliance is determined by adherence to established international standards and engineering performance testing, not by expert adjudication of clinical outcomes.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a respiratory gas humidifier, and its assessment focuses on engineering performance and safety standards, not on human interpretation of outputs that would typically be involved in an MRMC study.

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

Yes, the testing described is effectively "standalone" performance testing of the device itself (the MR810 System) against engineering and safety standards. This is done without human interpretation of results in a clinical setting as a primary outcome.

7. The type of ground truth used:

The ground truth used is established international engineering and safety standards for medical electrical equipment and respiratory humidifiers (ISO 8185, IEC 60601-1, IEC 60601-1-2). The device's performance is compared against the requirements specified in these standards. For the expanded invasive applications, the ground truth is simply that "the system is suitable for use for invasive applications" as verified by performance bench testing.

8. The sample size for the training set:

Not applicable. The MR810 System is a hardware device with embedded software controlling heating elements, not an AI/Machine Learning algorithm that typically requires a "training set" for model development. The "performance bench testing" mentioned refers to engineering validation rather than data-driven machine learning models.

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

Not applicable, as there is no "training set" for this type of device and its verification process.

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