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

The heated-wire breathing circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of humidified inspired gas, to reduce condensation. They are accessories for the Fisher & Paykel Healthcare MR850 Respiratory Gas Humidifier. The RT130 is used for flow rates between 0.3 and 4 L/min, and the RT131 is for flow rates greater than 4 L/min, for neonatal patients.

The MR850 Respiratory Humidifier is designed to condition the ventilatory gases for patients requiring assisted breathing, by raising the water vapor content and temperature of the gases delivered to patients.

It consists of an electrically powered heat controller, utilizing a microprocessor with embedded software, to control a heating element that transfers heat to the water in a chamber. Breathing tubes enable the humidified gas to be transported to the patient. Depending on the chosen configuration, these tubes may be electrically heated, by means of a heater-wire placed internally to the tubes, to minimize the loss of humidity. An electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit and incorporates protection circuitry to prevent voltage and current transients on the heater-wire.

Temperature probes in the gas path provide feedback on temperature and flow of the gas to regulate temperature and humidity to the patient.

The provided text describes a 510(k) summary for the Fisher & Paykel Healthcare MR850 Respiratory Humidifier. The focus of the submission is on a modification to the electrical adaptor for the heated breathing circuit, specifically the incorporation of surge and over-current protection circuitry. The main objective of the regulatory submission is to demonstrate substantial equivalence to the predicate device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics in a tabular format as you might expect for a new device's primary performance claims. Instead, it relies on the concept of substantial equivalence to a predicate device.

Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the primary acceptance criterion is often demonstrating "substantial equivalence" to a legally marketed predicate device. This means the new device is as safe and effective as the predicate, either by having the same technological characteristics and intended use, or by having different technological characteristics but no new questions of safety and effectiveness, and demonstrating that it is as safe and effective as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify a "sample size" in terms of patient data or clinical cases for the tests. The testing described is non-clinical and focuses on the device's electrical and functional performance as compared to the predicate.
• Data Provenance: The testing was conducted by Fisher & Paykel Healthcare Limited. Given the company's location (New Zealand) and the regulatory submission to the FDA, it is likely the testing was conducted in New Zealand or under their direct supervision. The tests are described as non-clinical tests, which typically involve laboratory or bench testing rather than human subject data. The data is retrospective in the sense that it compares the new device's performance against an existing predicate device's established performance, rather than a new prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• This information is not provided in the document. For non-clinical, bench-level performance, the "ground truth" would likely be defined by engineering specifications, safety standards, and the performance characteristics of the predicate device. Expertise would come from the device's design and testing engineers, rather than medical experts establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set:

• This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, where there might be disagreement among reviewers regarding a diagnosis or outcome. Since the described tests are non-clinical and focus on electrical and functional performance, such adjudication methods are not relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing comparing the modified device to its predicate for performance and safety. It does not involve human readers interpreting data or a study to determine how human readers improve with or without AI assistance. The device is a respiratory humidifier, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

• No, a standalone (algorithm only) performance study was not done. This concept primarily applies to AI/ML algorithms. The MR850 Respiratory Humidifier is a physical medical device with embedded software for control, but it is not an AI diagnostic algorithm in the sense that would require a standalone performance study. The performance described relates to the device's functional operation (e.g., surge protection, alarming mechanisms).

7. Type of Ground Truth Used:

• The "ground truth" for the non-clinical tests would have been established by engineering specifications, safety standards (e.g., electrical safety standards, medical device specific standards), and the known performance characteristics of the predicate device. For example, the ground truth for surge protection would be successful disconnection of power within specified parameters during a simulated surge event, as defined by engineering design and relevant electrical safety standards.

8. Sample Size for the Training Set:

• This information is not applicable and not provided. "Training set" refers to data used to train AI/ML models. The MR850 is a hardware device with embedded control software; it does not involve machine learning in the conventional sense that would require a training set. The embedded software's logic is typically programmed based on design specifications and engineering principles, not "trained" on data.

9. How the Ground Truth for the Training Set was Established:

• This information is not applicable and not provided for the same reasons as (8). The functional parameters and control logic for the humidifier's software are based on engineering design, medical requirements for humidification, and safety considerations, rather than ground truth established for an AI training set.

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