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When used in NIV mode:
The Airvo 3 NV provides non-invasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lb/30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.

When used in High Flow mode:
The Airvo 3 NIV is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 NVV provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals.

The Airvo 3 NIV provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 NIV is not intended to provide total ventilatory requirements and is not intended for use during field transport.

AirSpiral NIV tube and chamber kit (900PT573):
For use with noninvasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lbs./30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support.

The subject device, F&P Airvo 3 NIV is a respiratory support device for the delivery of High Flow and NIV (Non-Invasive Ventilation) therapy intended to treat spontaneously breathing patients who would benefit from receiving High Flow or respiratory pressure support. The Airvo 3 NIV is NOT to be used for life-supporting or life-sustaining purposes.

The Airvo 3 NIV is a non-implantable, prescription-only device, provided in a non-sterile state, and intended to be used by healthcare professionals, namely respiratory therapists, doctors and nurses in hospitals. When used in High Flow mode, the Airvo 3 NIV delivers gas at flow rates of between 2-70 L/min. The Airvo 3 NIV also has three non-invasive ventilation therapy modes: CPAP, Bi-Level S/T and Bi-Level PCV.

The AirSpiral NIV Tube and Chamber Kit is a single limb circuit kit designed for use with the Airvo 3 NIV device, for non- ventilator dependent, spontaneously breathing adult patients with respiratory insufficiency.

The provided text is a 510(k) Summary for the F&P Airvo 3 NIV device. It focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this document as it does not describe an AI/ML device or a study of its clinical performance against specific acceptance criteria for such an algorithm.

However, I can extract information related to performance testing from the "PERFORMANCE DATA VII." section, which includes "Bench / Performance Testing."

Here's an attempt to answer your request based on the provided document, noting the limitations due to the nature of the submission:

Acceptance Criteria and Study for F&P Airvo 3 NIV (K233643)

The F&P Airvo 3 NIV is a respiratory support device and not an AI/ML driven diagnostic or therapeutic device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical testing performed to establish substantial equivalence to predicate devices and ensure general safety and effectiveness in line with recognized medical device standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance testing conducted but does not explicitly state numerical acceptance criteria or reported device performance values in a table format. Instead, it states that the testing "demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device" and that "The testing demonstrated the appropriate biocompatibility profile for the device" and "The system complies with ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014 and AIM Standard 7351731 Rev. 3.00 2017-02-23" as well as "Alarms testing was performed in accordance with ANSI AAMI IEC 60601-1-8:2006 and A1:2012." For reprocessing, "The acceptance criteria and endpoints used are based on the following standard: AAMI TIR30:2011". For comparative performance, it states "Comparative performance testing was performed to demonstrate substantial equivalence."

Given the information, a table with specific numerical acceptance criteria and performance values cannot be fully populated as requested for items like blending accuracy, flow rate accuracy, etc. The document implies compliance with relevant standards as the "acceptance criteria."

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

• Not applicable for an AI/ML context. This device is hardware with embedded software, thus performance testing involves engineering verification and validation, not a test set of patient data for an algorithm. The testing described focuses on functional aspects of the device, not an algorithm's performance on a dataset.

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

• Not applicable for an AI/ML context. Ground truth, in the sense of clinical expert assessment of data, is not mentioned in relation to the device's technical performance testing.

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

• Not applicable for an AI/ML context. This type of adjudication is relevant for resolving discrepancies in expert interpretations of clinical data, which is not described here.

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:

• Not applicable. This device is not an AI-assisted tool for human readers.

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

• Not applicable. This device does not feature a standalone algorithm performing a diagnostic or therapeutic task.

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

• For engineering and performance testing described (electrical safety, EMC, flow rate accuracy, etc.), the "ground truth" would be established physical and engineering principles, international standards, and measurements from calibrated reference instruments. It is not clinical "ground truth" as typically defined for AI/ML performance.

8. The sample size for the training set:

• Not applicable. There is no mention of an AI/ML training set. Software verification and validation refer to standard software engineering practices.

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

• Not applicable. There is no mention of an AI/ML training set or its associated ground truth establishment.

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The myAirvo 3 is for the treatment of spontaneously breathing patients, infant to adult, who would benefit from receiving high flow warmed and humidified respiratory gases. This includes patients who have had upper airways bypassed. The flow may be from 2 - 60 L/min depending on the patient interface. The myAirvo 3 is for patients in homes and long-term care facilities.

The F&P myAirvo 3 device is a heated humidifier flow source. The subject device is intended to treat spontaneously breathing patients, pediatrics and adults, who would benefit from receiving high flow, warmed and humidified entrained air and oxygen (if required).

The F&P myAirvo 3 is comprised of two main connected functional units: the blower and the humidifier.

The blower is a motorized fan assembly that provides air flow. The fan speed is directly related to the delivered flow and it is controlled by the software. The blower assembly output connects directly to a humidification chamber at the front of the device.

The second functional unit of the F&P myAirvo 3 device is a heated Passover humidifier. The water is contained in a humidification chamber positioned on a heater plate at the front of the unit. The gas is warmed and humidified in the chamber to the dew point set temperature, transported through the heated breathing tube and delivered to the patient through the selected interface.

This document is a 510(k) Summary for the F&P myAirvo 3, a respiratory humidifier. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not contain acceptance criteria or study data related to the performance of an AI/ML powered device. The provided text primarily focuses on comparative claims against a predicate device and adherence to various safety and performance standards relevant to a medical device's physical and functional specifications.

Therefore, I cannot extract information about acceptance criteria or a study proving an AI/ML device meets them from this document. The questions posed in the prompt (regarding AI/ML performance, sample sizes, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the content provided, as it describes a traditional medical device (a respiratory humidifier) and not an AI/ML algorithm.

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Indications for use - AIRVO nebulizer adapter:

When used with a nebulizer:

The nebulizer adapter is a medical device accessory for single-patient use to facilitate aerosolization of Albuterol sulfate for inhalation to adult patients receiving high-flow humidified breathing gases via tracheostomy patient interface. Intended for use by healthcare professionals in hospitals or long-term care facilities.

When used without a nebulizer:

For use in hospitals and long-term care facilities, for the delivery of humidified respiratory gases to patients via nasal, tracheostomy and mask interfaces.

The Airvo Nebulizer Adapter (hereafter named "nebulizer adapter") is a single use accessory device designed to facilitate aerosolization of a physician-prescribed solution for inhalation to patients receiving high flow humidified breathing gases. The nebulizer adapter is a prescription-only accessory device, provided in a non-sterile state.

The nebulizer adapter is kitted with the AirSpiral tube and MR290 humidification chamber cleared in K162553, to be used in conjunction with Airvo series humidifiers (K131895) along with patient interfaces cleared in K162553.

The device is labelled for use with Salbutamol/ Albuterol only.

Here's a breakdown of the acceptance criteria and study information for the Airvo Nebulizer Adapter, based on the provided FDA 510(k) summary:

This device is a nebulizer adapter, not an AI-powered diagnostic device, so many of the requested categories (like MRMC study, expert qualifications for ground truth, AI improvement effect size, standalone algorithm performance, or training set details) are not applicable. The "ground truth" for this type of medical device largely pertains to its physical and functional performance against established medical device standards and the predicate device, rather than a diagnostic label.

Acceptance Criteria and Reported Device Performance

Device Name: Airvo Nebulizer Adapter
Predicate Device: Aeroneb Solo Nebulizer System / Aeroneb Solo Adapter (K133360)

Study Details

Given this is a 510(k) for a medical device accessory and not an AI/CADe/CADx device, the study information requested regarding human readers, AI assistance, ground truth experts, and training sets is not directly applicable in the context of this submission. The "studies" were primarily non-clinical, benchtop performance, and engineering tests to demonstrate substantial equivalence to the predicate device and compliance with relevant standards.

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify exact sample sizes for each non-clinical test (e.g., number of nebulizer adapters tested for respirable dose, number of cycles for shelf life, etc.). The provenance would be the manufacturing site laboratory in New Zealand, and the data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not Applicable. For this type of device, "ground truth" is established by adherence to recognized national and international consensus standards (e.g., ASTM, ISO), engineering specifications, and comparative testing against a legally marketed predicate. The "experts" are the engineers and medical device professionals who design and execute these tests and evaluate the results against the defined criteria. Their qualifications would involve expertise in medical device engineering, respiratory therapy, and regulatory affairs.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not Applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple human readers for diagnostic truth-finding in image-based AI studies. This is a non-clinical device performance study. Test results are typically reviewed and approved by internal quality and regulatory personnel.

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:
Not Applicable. This is a physical medical device, not an AI-powered diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not Applicable. This is a physical medical device, not an algorithm. The "standalone" performance would be its mechanical and functional characteristics as tested on a benchtop.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on:

• Adherence to recognized national and international consensus standards: (e.g., ISO 80601-2-74 for respiratory humidifying equipment, ISO 10993 for biocompatibility, ISO 18562 for breathing gas pathways).
• Performance specifications and engineering requirements: The device's ability to reliably deliver the specified respirable dose and MMAD, maintain pressure, prevent condensate buildup, and ensure component integrity.
• Direct comparative testing against a legally marketed predicate device: Demonstrating that the subject device's performance is equivalent to or better than the predicate's performance in critical aspects (e.g., respirable dose, MMAD).

8. The sample size for the training set:
Not Applicable. This device is not an AI model, so there is no "training set."

9. How the ground truth for the training set was established:
Not Applicable.

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