Search Results

NOA SLEEP APNEA AND SNORING DEVICE is a mandibular advance device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.

The NOA Sleep Apnea and Snoring Device is a customized prescription intraoral mandibular advancement device for snoring and obstructive sleep apnea intended for single-patient use by those who are 18 years or older. The device consists of CAD/CAM fabricated maxillary and mandibular splints connected by symmetrical, twin-mated posts that are customizable to allow lateral jaw movement as well as jaw opening. The series of one or more mandibular splints, and one or more maxillary splints to be exchanged with other splints in the series according to the prescriber, to titrate protrusive jaw movement according to patient comfort and needs. The described mandibular advancement is intended to reduce snoring and mild to moderate obstructive sleep apnea by holding the mandible and base of tongue forward during sleep, to provide increased pharyngeal space to improve the patient's ability to exchange air and decrease air turbulence. The NOA Sleep Apnea and Snoring Device does not have any additional adjustment mechanisms to modify or maintain the mandibular position such as pistons, straps, repositioning elastics or screws, eliminating the need for utilizing external controlling components such as keys, screwdrivers or ligature ties. The NOA device is designed with lateral fins called cam and follower. Contact between the cam and the follower prevents any mandibular retrusion even with the opening of the mouth. The device design is configured according to the patient's specific dental arch, to maximize tongue space and to allow open, close and laterality movements during wear. These movements can be personalized by the doctor. Furthermore, the doctor can change the height of the cam in the prescription to limit the maximum mouth opening during wear. Orthoapnea NOA device designs can be Standard or Customized. A Standard device is designed with standard height in the lateral cams among all lower splints. If the practitioner provides a measurement of the antero-posterior mobility (Maximum retrusion), a Customized device is designed decreasing the height of the cam according to the degree of advancement. increases, the ability to open the mouth without mandibular retrusion decreases, making the cam shorter. The following additional device design features can be customized when ordering the prescription device: Advance regulation/titration sequence, Lateral movement, Device opening limit, Frontal opening of the device.

The provided document is a 510(k) summary for a medical device called "NOA Sleep Apnea and Snoring Device." It outlines the device's technical characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.

Crucially, this document does not contain any information about an AI/ML-based device or a study involving human readers or AI assistance. The device described is a physical intraoral mandibular advancement device. Therefore, the requested information regarding acceptance criteria, performance metrics, sample sizes for AI/ML models, expert ground truth establishment, MRMC studies, and standalone algorithm performance cannot be extracted from this document.

The document explicitly states:

• "No clinical testing was performed." (Page 6, Section E)
• "Non-clinical testing was used to support the determination of substantial equivalence." (Page 6, Section E)

Therefore, I cannot fulfill the request as it pertains to an AI/ML device and its validation. The document describes a traditional medical device (mandibular appliance) and its clearance process based on non-clinical bench testing and comparison to existing predicate devices.

Ask a specific question about this device