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The aura CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30kg) with Obstructive Sleep Apnea.

The aura CPAP System provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. During obstructive sleep apnea, the airway collapses. When interfaced with a CPAP Mask or CPAP Patient Interface the aura CPAP System provides a constant pressure of 4 to 20 cmH2O above the ambient atmospheric pressure to patient's nasal airway. This constant pressure supports retaining an open airway during sleep.

The aura CPAP System has four significant components:

• 1. CPAP Blower,
• 2. Optional Humidifier,
• 3. Optional Battery Pack, and
• 4. Patient Interface.

The provided document describes the AEIOMed aura CPAP System, a device intended for the treatment of obstructive sleep apnea. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically expected for a detailed scientific or clinical study.

Instead, the document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. The "Summary of Safety and Effectiveness" section and the FDA letter confirm this.

Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, detailed ground truth methods, training set details) are not available in this specific document, as those are generally associated with more extensive clinical trials or performance studies that were likely not required for a 510(k) submission based on substantial equivalence and laboratory testing.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not explicitly stated/Provided. The document refers to "Laboratory and standards compliance" but does not detail a clinical test set with human subjects. The evaluation for 510(k) substantial equivalence often relies on bench testing, electrical safety, and biocompatibility rather than extensive clinical studies if the technology is well-established and has predicate devices.
• Data Provenance: Not specified, but given it's a US company seeking FDA clearance, any supporting data would likely adhere to US regulatory standards.

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

• Not applicable/Provided. This type of detail is absent because the submission focuses on substantial equivalence and laboratory testing, not a clinical study requiring expert ground truth for interpretation of outcomes.

4. Adjudication method for the test set

• Not applicable/Provided. No clinical test set with adjudicated outcomes is described.

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. This is not an AI-assisted device. It's a medical device (CPAP system) for delivering continuous positive airway pressure. Therefore, an MRMC study related to AI assistance is irrelevant.

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

• Not applicable. This question pertains to algorithmic performance, which is not relevant to a mechanical CPAP device.

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

• Not applicable. For this type of device and submission, the "ground truth" would be related to engineering specifications, safety standards, and performance characteristics demonstrated through bench testing, rather than clinical outcomes or diagnoses. The device's ability to maintain a prescribed pressure and operate safely and effectively as designed would be the focus.

8. The sample size for the training set

• Not applicable/Provided. There is no indication of a "training set" in the context of machine learning or AI, as this is a mechanical medical device.

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

• Not applicable/Provided. As above, no training set or machine learning components are mentioned.

In summary: The document is a 510(k) clearance summary, which primarily aims to demonstrate substantial equivalence to existing devices through appropriate testing (likely bench testing and compliance with relevant standards) rather than extensive de novo clinical trials with human subjects and expert adjudication of outcomes. Therefore, much of the requested information related to clinical study design and performance metrics against specific, numerically defined acceptance criteria is not present here. The main "acceptance criterion" presented is substantial equivalence, which the FDA concurred with.

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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.

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.

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:

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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