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The Aura™ CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.

Device Description

The Aura™ CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP. The Aura™ CPAP Patient Interface has three significant components: 1) Headgear Assembly, 2) Nasal Seal Assembly, and 3) Tubing and Adjustment Assembly. The Headgear Assembly holds the device Tubing and Adjustment Assembly, and the Nasal Seal Assembly in place on the user's head. The Headgear Assembly is adjustable by the user. The Nasal Seal Assembly is made from a silicone material which connects to the Tubing and Adjustment Assembly. The Nasal Seal Assembly provides the airflow pathway to the user's nasal openings. The Tubing and Adjustment Assembly connects to the CPAP System. The Tubing and Adjustment Assembly passes the constant air pressure of the CPAP System to the Nasal Seal Assembly. The Tubing and Adjustment Assembly allows the positioning of the Nasal Seal Assembly for the comfort of the user. The Tubing and Adjustment Assembly allows for the positions of the Nasal Seal Assembly in both dimensions: away from the face and in the vertical direction.

AI/ML Overview

This document is a 510(k) premarket notification for the Aura™ CPAP Patient Interface. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes. Therefore, many of the requested elements (e.g., sample sizes, expert qualifications, MRMC studies, training set details) are not explicitly present in the provided text.

Based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Reported Device Performance (Implied)
Intended Use Equivalence	The Aura™ CPAP Patient Interface functions as an accessory to CPAP devices for treating Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy, which is consistent with the intended use of the predicate devices.
Technological Equivalence	The device has three significant components (Headgear, Nasal Seal, Tubing/Adjustment Assembly) which are functionally equivalent to components found in similar nasal CPAP masks.
Safety and Effectiveness	Laboratory testing and compliance with standards were provided. No new questions of safety or effectiveness are raised compared to predicate devices. (Specific performance metrics are not detailed).
Material Equivalence	The Nasal Seal Assembly is made from silicone material, which is a common and accepted material for such devices. (Performance details not provided explicitly).

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

Sample Size: Not explicitly stated. The document refers to "Laboratory and standards compliance" being provided, suggesting a bench study or testing against recognized standards rather than a clinical human test set with a specific sample size.
Data Provenance: Not explicitly stated, given the nature of the submission focusing on substantial equivalence based on technical specifications and standards compliance, rather than a clinical trial.

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

Not applicable/Not mentioned. Ground truth in the context of device performance for substantial equivalence is typically established through engineering specifications, material testing, and compliance with industry standards, not by expert consensus on clinical cases in the way an AI diagnostic algorithm might be evaluated.

4. Adjudication method for the test set:

Not applicable/Not mentioned. Adjudication methods are relevant for clinical studies involving human interpretation or challenging diagnoses, which is not the primary focus of this 510(k) submission.

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 device is a physical medical accessory (CPAP mask), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

The ground truth in this context is based on engineering specifications, material properties, laboratory testing against recognized standards (e.g., biocompatibility, pressure performance, leak rates for CPAP masks), and functional equivalence to legally marketed predicate devices. It does not involve expert consensus on clinical cases or pathology reports in the manner of a diagnostic device.

8. The sample size for the training set:

Not applicable. Training sets are relevant for machine learning algorithms. This device is a physical medical accessory.

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

Not applicable. As this is not an algorithm, there is no training set or ground truth established in that manner.

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