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The Attune Sleep Apnea System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.

The Attune Sleep Apnea System consists of three (3) main components: a small electronic bedside console, a soft polymer mouthpiece, and a flexible polymer tube that connects the mouthpiece to the console. A mouthpiece holder is provided for mouthpiece storage and use during weekly system cleaning.

The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.

Console: The console generates a gentle negative pressure, collects excess saliva, records patient use time, and monitors pressure. The console is provided with a power cord, which connects to a standard electrical outlet. An optional laboratory console is available for use in a sleep laboratory. The laboratory console includes wires that extend from the console. The wires connect to the sleep laboratory's polysomnography (PSG) system, allowing the sleep technicians to view the console's pressure on the same monitor as the other PSG channels.

Mouthpiece: The mouthpiece is provided in ten (10) discrete sizes. Sleep technicians use a bite wax to obtain an impression of each patient's teeth and a sizing template to determine the best mouthpiece size.

Tubing: The tubing connects to the console by screwing into the console base and to the mouthpiece with luer connectors.

Use: The patient connects the system and places the mouthpiece in his or her mouth. The mouthpiece is worn during sleep. The console generates a gentle, negative pressure, which is delivered through the mouthpiece into the oral cavity and holds the tongue and soft palate out of the airway.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "Clinical Success was prospectively defined as AHI reduction of > 50% and treated AHI < 20." The reported device performance for these criteria is intertwined within the "Clinical Success" rate.

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

• Sample Size for Test Set: 63 subjects in the Primary Endpoint Cohort.
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the study was described as a "multi-center" trial, suggesting it likely took place across several locations, possibly within the United States given the FDA submission.
  • Retrospective or Prospective: Prospective. The study is described as "a four-week, multi-center, prospective, open label, randomized first-night order of control vs. treatment, single-arm trial."

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

This information is not provided in the document. The text does not detail how the AHI (Apnea-Hypopnea Index) measurements were established or adjudicated for the clinical trial, nor does it mention the involvement or qualifications of experts for this purpose.

4. Adjudication Method for the Test Set

This information is not provided in the document. The text does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the clinical trial results.

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

This information is not applicable/not provided. The device described is the "Attune Sleep Apnea System," which is an intraoral device for treating sleep apnea, not an AI or imaging diagnostic tool that would typically involve human readers or MRMC studies.

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

This information is not applicable/not provided. The device is a physical intraoral system, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used

The ground truth used for assessing the device's effectiveness was based on physiological measurements of sleep apnea, specifically:

• AHI reduction of > 50%
• Treated AHI < 20

These measurements are standard metrics derived from polysomnography (PSG) studies, which are considered the gold standard for diagnosing and assessing the severity of sleep apnea. The document mentions "polysomnography (PSG) system" in relation to the laboratory console, implying PSG was the method for collecting relevant data.

8. The Sample Size for the Training Set

This information is not explicitly provided as this type of device (physical medical device) typically undergoes traditional clinical trials, not machine learning model training. The concept of a "training set" in the context of AI/ML is not directly relevant here. However, the document does mention "two feasibility studies" that preceded the pivotal trial.

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

As with point 8, the concept of a "training set" and its ground truth establishment in an AI/ML context is not directly applicable. For the clinical trials, the "ground truth" (i.e., the actual AHI values) would have been established through standard clinical diagnostic procedures, likely polysomnography, as accepted in sleep medicine.

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