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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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