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The Cloud9® System is indicated for use by adults to reduce or eliminate simple snoring. The Cloud9® System maintains a continuous, positive low-pressure in the airway. The device is designed for prescription home use.

Device Description

The Cloud9® System is a device for delivery of low levels of continuous positive airway pressure (CPAP) that can be used by people who wish to reduce or eliminate their snoring. lts main components include the airflow unit (AFU) and custom nasal mask interface, called the NiteCap™. The Cloud9® System delivers CPAP at low pressures ranging from 2 to 4 cmH₂O, via a nasal interface. The blower generating the airstream is controlled continuously based on pressure measurements at the nasal interface to maintain the pressure at the nose of the user constant ("CPAP"). Its performance is similar to currently used CPAP devices.

AI/ML Overview

The provided text describes the Cloud9® System, a medical device intended to reduce or eliminate simple snoring, and details a clinical study conducted to evaluate its safety and efficacy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

Study Endpoint / Acceptance Criteria	Reported Device Performance	Conclusion
Primary Endpoint: Reduction in the number of all snores or reduction in loud snores as percent of sleep time with the device (Visits #2 and #3). Success Criteria: 50% reduction in all snores OR at least a 90% reduction in loud snores as a percent of sleep time.	There was an average of 86% reduction in loud snoring and 67% reduction in all snoring. This meets the success criteria of "greater than 50% reduction in all snores."	The Cloud9 System is effective for its indication to reduce or eliminate simple snoring. The primary endpoint was met with a greater than 50% reduction in all snores.
Secondary Endpoint: Reduction in overall nightly noise exposure below the WHO limit of 45 dBA. Success Criteria: 50% reduction in snoring time > 45 dBA.	Loud snoring was reduced from 34% of sleep time to 5% of sleep time with the Cloud9™. The total time spent in loud snoring was reduced from 148 minutes to 18 minutes, which is a greater than 50% reduction.	The Cloud9 System is effective for its indication to reduce or eliminate simple snoring. The secondary endpoint was met with a greater than 50% reduction in snoring time ≥ 45 dBA (loud snoring).
Safety Endpoint: No adverse events (nasal or skin irritation, epistaxis, and sleep disruption) noted.	No adverse events occurred during this study.	The safety endpoint was met.

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

Sample Size: A total of 24 subjects were evaluated.
Data Provenance: The study was a prospective, interventional study. The country of origin of the data is not specified in the provided text.

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

The text indicates that snoring and sleep parameters were assessed by PSG (Polysomnography). PSG is a medical test that records various physiological signals during sleep, often interpreted by trained sleep specialists or pulmonologists. However, the exact number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated in this document.

4. Adjudication Method for the Test Set

The text describes that the study used PSG for baseline assessment and device evaluation. However, it does not specify an adjudication method (e.g., 2+1, 3+1, none) for the test set interpretation beyond stating that PSG was used.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

This document describes a clinical study evaluating the Cloud9® System's effectiveness in reducing snoring, with subjects serving as their own controls (comparing baseline to device use). It does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. The device itself is a Continuous Positive Airway Pressure (CPAP) system, not an AI-powered diagnostic or assistive tool for human interpretation.

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

The Cloud9® System is a hardware device (CPAP system) that delivers positive airway pressure. It's not an AI algorithm in the context of diagnostic image analysis or similar applications where standalone algorithm performance would be relevant. Therefore, a standalone algorithm performance study, as typically understood in AI/ML medical devices, was not performed or relevant in this context. The study evaluates the device's physiological effect on snoring.

7. The Type of Ground Truth Used

The ground truth for the test set endpoints (reduction in snores, reduction in loud snoring time) was established using Polysomnography (PSG) measurements for snoring and sleep parameters. This can be considered objective physiological measurement data, rather than expert consensus, pathology, or direct outcomes data (though snoring reduction is an outcome).

8. The Sample Size for the Training Set

The document describes a clinical study with 24 subjects for evaluating the device's efficacy. It does not mention a separate "training set" for an algorithm or AI model. The Cloud9® System is a mechanical device, not a machine learning model that requires a training set.

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

As there is no mention of a "training set" or an AI/ML component requiring such a set, this question is not applicable based on the provided text.

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