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The Sleepnet MoJo™ Full Face Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O for the treatment of adult obstructive sleep apnea.

The mask is intended for single patient use and reuse in the home or hospital/institutional environment. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.

The Sleepnet MoJo™ Full Face Mask is an externally placed mask covering the nose and mouth of the patient. It provides a seal such that positive pressure from a positive pressure source is directed to the patient's nose and mouth when either or both are open. It is held in place with an adjustable headgear. It may be cleaned with mild detergent, such as Ivory® dishwasher liquid, in water. The cleaning process requires limited disassembly.

The mask consists of a molded flexible polyvinylchloride shell with a soft, resilient polyurethane encased silicone gel skin-contacting seal that conforms to the patient's facial features. The polvvinylchloride shell contains a malleable metal insert that allows the user to adjust the entire perimeter of the facial seal in any configuration.

The mask connects to a conventional air delivery hose between the mask and the positive airwav pressure source via a standard 22 mm polycarbonate elbow/swivel/valve assembly. The elbow/swivel/valve assembly attaches to the front of the mask with a polycarbonate split "c" clip.

The air delivery system consists of a 22mm polycarbonate swivel connector for 22mm tubing. The built in vent ports are located on the elbow/swivel/valve assembly to provide a continuous air leak to prevent rebreathing of deadspace CO2, direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent ports also allow the patient to exhale normally and do not interfere with the other performance requirements of the device. The vent ports may be visually checked for obstruction prior to use. The elbow/swivel/valve assembly also includes a built in Anti-Asphyxia Valve which allows the patient to continue to breathe fresh air in the event of positive air pressure device failure or output deterioration, or delivery hose kinking/obstruction.

An optional polypropylene adapter sold separately as an accessory may be used to connect to a pressure measurement or oxygen delivering device.

The Sleepnet MoJo™ Full Face Mask assembly will be packaged along with an instructions for use sheet in a standard poly bag.

The Sleepnet MoJo™ headgear is available in a variety of sizes to fit a broad range of facial structures, and attaches to the mask via slots contained within the shell.

The provided text is a 510(k) summary for a medical device called the "Sleepnet MoJo™ Full Face Mask". This document is a regulatory submission to the FDA for market clearance, not a scientific study report. Therefore, it does not contain the detailed information required to fill out a table of acceptance criteria, device performance, or study specifics like sample sizes, ground truth establishment, or expert qualifications as typically found in clinical trials or performance studies.

The document primarily focuses on demonstrating "substantial equivalence" to a predicate device based on technological characteristics and tests performed. It does not describe a clinical study designed to prove specific performance metrics against pre-defined acceptance criteria with the rigor of a clinical trial.

Here's what can be extracted and what cannot:

• Acceptance Criteria & Device Performance: The document states, "Tests performed on the Sleepnet MoJo™ Full Face Mask demonstrate substantial equivalence to the predicate device listed above." However, it does not list specific acceptance criteria (e.g., "leakage rate must be

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