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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.

Specifics on the modified component:

• Surge Condition: Adaptor disconnects heater-wire for a period (up to 4 seconds) dependent on transient magnitude.
• Detection Logic: If heater-wire remains disconnected during a detection cycle, humidifier illuminates warning indicators and audibly alarms.
• Reconnection: Normal operation resumes once heater-wire is reconnected.
• Over-current Condition: Heater-wire disconnected for a fixed 4 seconds.
• Persistent Over-current: If over-current persists after reconnection, heater-wire is disconnected again, and humidifier continues to alarm.
• Risk Minimization: These actions aim to minimize risks associated with fault conditions. |
  | Maintains intended use and technological characteristics | "The modified MR850 Respiratory Humidifier is substantially equivalent to the predicate MR850 humidifier and uses the same method of control and delivery of humidity."

"The comparison of features, performance, and intended use demonstrate that the MR850 Respiratory Humidifier is at least as safe and effective for its intended purpose." |

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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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 or prevent condensation and to it 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 humidifier is a Respiratory Gas Humidifier (heated pass-over type) according to 21 CFR §868.5450. Heat is used to provide evaporated water content to dry breathing gases. Heated or unheated breathing tubes can be used to deliver the humidified gas to the patient. Heated breathing tubes increase operating efficiency and reduce excessive water and heat loss.

The MR850 has a thermoplastic enclosure with dimensions of 140 mm high × 135 mm wide × 173 mm deep, and weighs 2.8 kg. A heater plate 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 chambers, breathing circuits, electrical adapters and temperature / flow probes.

The chamber slides on to the heater plate 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 yentilator to humidifier, inspiratory limb to the patient, and expiratory limb for return to the ventilator. When used with heated breathing circuits the electrical adapter from the humidifier 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. Invasive Mode is used for patients who have bypassed upper airways, and delivers humidified gas to the patient at 37 ℃ (body temperature). Non-Invasive Mode is used for patients receiving breathing gases via a face mask, and delivers humidified gas to the patient at 31 ℃. The MR850 humidifier monitors temperature, flow parameters and equipment integrity, in order to maintain stable performance conditions. It will also notify the user of high delivered temperature, or incorrect equipment set-up conditions, and when in the invasive mode, of inadequate delivered humidity.

Here's a breakdown of the acceptance criteria and the study descriptions for the Fisher & Paykel MR850 Respiratory Humidifier, as derived from the provided document:

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the clinical verification studies (test set). It only refers to "clinical verification studies" in a general sense.

The provenance of clinical data is not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications. The "clinical verification studies" likely involved medical staff, but specific details are not provided.

4. Adjudication Method for the Test Set

The document does not mention an adjudication method for the test set.

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

The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device is a respiratory humidifier, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

The device itself is a piece of medical equipment, not an algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable in the typical sense for an AI device. The humidifier operates autonomously to deliver humidified gas, based on its internal controls and sensors, without requiring constant human intervention beyond initial setup and monitoring. The "performance" refers to the device's ability to maintain specific temperature and humidity levels.

7. Type of Ground Truth Used

The ground truth for the performance claims appears to be derived from direct measurements of the device's output (temperature, humidity, flow parameters) during operation, and likely observations of patient outcomes/comfort in clinical settings. The "clinical verification studies" would have assessed the device's ability to achieve intended physiological effects.

8. Sample Size for the Training Set

The concept of a "training set" is not explicitly applicable here, as this is a physical medical device, not an AI model that undergoes a training phase with a distinct dataset. The development process involved engineering, testing, and refinement, but not in the same way an AI model is trained.

9. How the Ground Truth for the Training Set Was Established

As explained above, a "training set" in the context of AI models is not applicable. The device's design and engineering would have been informed by established medical standards for respiratory humidification, physiological requirements for patients, and results from initial design verification and validation testing, which serve as the "ground truth" for its functional and performance characteristics.

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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 Humidifier is a Respiratory Gas Humidifier (heated pass-over type) according to 21 CFR §868.5450. Heat is used to provide 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 140 mm high × 135 mm wide × 173 mm deep, and weighs 2.8 kg. A heater plate 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 chambers, breathing circuits, electrical adaptors and temperature / flow probes.

The chamber slides on to the heater plate 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 ℃ (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, flow parameters and equipment integrity, in order to maintain stable performance conditions. It will also notify the user of high delivered temperature. inadequate delivered humidity, or incorrect equipment set-up conditions.

The provided text describes the 510(k) summary for the MR850 Respiratory Humidifier, which is a regulatory submission to the FDA. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically found in a clinical trial report.

Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not explicitly stated in this type of regulatory summary. The information provided is high-level and focused on general compliance and safety/effectiveness demonstrations.

However, I can extract the available information and indicate where details are not provided in this specific document.

Acceptance Criteria and Device Performance (Based on provided text)

The document primarily states that the MR850 Humidifier meets the requirements of various standards and demonstrates safety, effectiveness, and performance. Specific quantitative acceptance criteria or reported performance values are not detailed in a table format. Instead, the general compliance is asserted.

Detailed Study Information (Based on provided text):

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

   • Test Set Sample Size: Not specified in the provided text. The document refers to "Clinical verification studies" but does not give details about the number of patients or duration of these studies.
   • Data Provenance: Not specified explicitly. The clinical verification studies were likely conducted internally or by contracted organizations associated with Fisher & Paykel Healthcare. The context implies these are prospective clinical evaluations rather than retrospective data analysis, given they are "verification studies."

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

   • This information is not provided in the text. Clinical verification studies would typically involve medical professionals, but their number and specific qualifications (e.g., specific specialties, years of experience) are not detailed.

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

   • This information is not provided in the text. Adjudication methods are specific to studies involving expert review and interpretation, which are not directly detailed here.

4. 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:

   • This is not applicable and not mentioned in the text. The MR850 Humidifier is a physical medical device (humidifier), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to human reader performance with or without AI assistance would not be relevant.

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

   • This is not applicable in the context of an algorithm. The device itself (the humidifier) has "standalone" performance in its function as a humidifier. The document states:
     • "Non-clinical testing of the MR850 Humidifier has been carried out covering... functional verification, and performance capacity and accuracy."
     • "Clinical verification studies on the MR850 Humidifier demonstrated the safety, effectiveness and performance of the device."
     • This implies the device was tested for its inherent performance without continuous human intervention during operation, as would be expected for a medical device.

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

   • For the "Clinical verification studies," the ground truth for effectiveness would likely be based on:
     • Measured temperature and humidity levels: Comparing device output to established physiological requirements for humidified respiratory gases (e.g., 37 °C for intubated mode, 31 °C for mask mode).
     • Patient outcomes/physiological parameters: Assessing patient comfort, respiratory status, or prevention of airway irritation/desiccation.
   • For safety, ground truth would involve:
     • Adverse event reporting: Observing for any patient harm or device malfunction.
     • Compliance with electrical/thermal safety standards: Measured against documented safety limits.
   • The document mentions "performance capacity and accuracy" in non-clinical tests, suggesting quantitative measurements against specifications.

7. The sample size for the training set:

   • This information is not provided in the text. The MR850 is a hardware device with embedded control algorithms (e.g., PID algorithm). The "training set" concept is typically relevant for machine learning models, which are not the primary focus of this device's regulatory review. If "training" refers to iterative design and testing during development, the specific size of data used in such iterations is not documented here.

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

   • This information is not provided and is generally not applicable in the context of a traditional hardware humidifier's regulatory summary. The device's "ground truth" (i.e., correct operational parameters) would be based on established medical and engineering principles, physiological requirements for respiration, and relevant international standards. The PID algorithm would be tuned based on engineering control theory and empirical testing to achieve desired temperature and humidity outputs.

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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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