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AquinOx is designed for use to add moisture to and to warm breathing gases for administration to a patient.

The AquinOx Humidifier is a single patient use device. The device attaches to a compressed air or oxygen source. The input air or oxygen is warmed and humidified before leaving the device. AquinOx attaches to the P20000 heater manufactured by Pegasus Research Corporation and is compatible with multiple commercially available water bottles.

The provided text describes the AquinOx Humidifier and its 510(k) submission. However, it explicitly states that no clinical studies were necessary to demonstrate the device's safety, effectiveness, and performance. Therefore, a comprehensive set of acceptance criteria and a study proving device performance against those criteria, as typically seen in clinical trials or performance studies involving efficacy endpoints, are not present in this document.

Instead, the submission relies on non-clinical studies (thermal safety, environmental, and functional performance) and a claim of substantial equivalence to predicate devices. This means the acceptance criteria are implicitly met by demonstrating that the AquinOx performs similarly to already-approved devices, rather than establishing de novo performance benchmarks.

Below is an attempt to address your request based on the information provided, acknowledging the limitations for a full response:

1. Table of Acceptance Criteria and Reported Device Performance

As no specific quantitative acceptance criteria or detailed performance results from a clinical study are provided, this table is based on the general statements made in the submission.

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

• Test Set Sample Size: Not applicable, as no clinical test set involving human subjects was used for performance evaluation in the context of efficacy or diagnostic accuracy. The "test set" would refer to the units tested in non-clinical lab studies. The document does not specify the number of units tested.
• Data Provenance: Not applicable in the context of patient data. The "data" comes from engineering and lab testing of the device itself.

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

• This is not applicable as there was no clinical test set requiring expert-established ground truth. The "ground truth" for the non-clinical tests would be defined by engineering specifications and standards.

4. Adjudication Method for the Test Set

• Not applicable as there was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device does not involve human interpretation of outputs that would benefit from such a study (e.g., medical imaging AI).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This concept is not directly applicable. The AquinOx is a medical device, not an AI algorithm. Its performance is inherent to its physical operation, not a software algorithm that can be evaluated in "standalone" mode. The non-clinical studies implicitly evaluate its "standalone" physical performance.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical studies would be defined by engineering specifications, established physical principles, and relevant industry/regulatory standards for humidifier performance (e.g., temperature and humidity output accuracy, safety limits). There is no "expert consensus," "pathology," or "outcomes data" ground truth referenced, as no clinical study was performed.

8. The Sample Size for the Training Set

• Not applicable. The AquinOx Humidifier is not an AI/ML device that requires a training set. Its design and validation rely on engineering principles, materials science, and testing, not data-driven model training.

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

• Not applicable, as there is no training set for this type of device.

Summary of Study (Based on Provided Text):

The submission for the AquinOx Humidifier did not include, nor did FDA require, clinical studies. The "studies" performed were non-clinical, focusing on thermal safety, environmental performance, and functional performance. The device's acceptance was based on demonstrating substantial equivalence to two legally marketed predicate devices by confirming that it uses similar technology and performs similarly in terms of safety and intended function. The ground truth for these non-clinical tests would have been engineering specifications and safety standards rather than clinical outcomes or expert consensus.

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