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The Prosomnus [CA] Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

The DentiTrac® micro-recorder is completely embedded into the Prosomnus [CA] Sleep and Snore appliance. The micro-recorder is intended to measure patient compliance to the oral appliance therapy in combination with the DentiTrac® System.

The Prosomnus [CA] Sleep and Snore device consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate sleep apnea by holding the mandible forward during sleep. providing increased pharyngeal space. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the Prosomnus [CA] Sleep and Snore device series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions up to 11mm to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The Prosomnus [CA] Sleep and Snore device twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear.

This submission adds the option for an embedded screw that allows for smaller discreet movements of the mandible in between the lower arch advancements. The inclusion of the embedded screw does not change the intended use, impact the operating principles nor impact the fundamental scientific principles of the device as established by the predicate device K133683, the MicrO2 OSA device. The same principles of operation to move the mandible forward are used to increase pharyngeal space and maximize the tongue space.

The Prosomnus [CA] Sleep and Snore device includes an optional Micro-recorder to monitor patient compliance.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in relation to an AI algorithm or its effectiveness in reducing snoring and sleep apnea.

The document is a 510(k) premarket notification for the Prosomnus [CA] Sleep and Snore Device and the Prosomnus [CA] Sleep and Snore Device with Micro-recorder. The purpose of this notification is to demonstrate substantial equivalence to previously cleared predicate devices, not to prove direct clinical efficacy or performance against defined acceptance criteria in a clinical study.

The "Substantial Equivalence" sections (pages 5 and 9) describe the basis for deeming the devices substantially equivalent to their predicates. This equivalence is primarily based on:

• Identical Indications for Use: Both the predicate and the subject devices are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
• Technological Characteristics: The operating principles, materials, manufacturing process (digital milling), and mechanism to move the mandible forward are considered similar.
• In Vitro Testing: The document mentions "Compression and Shear Torsion Testing" and "Package and Distribution Testing" as data relied upon to determine substantial equivalence. These are mechanical and packaging tests, not clinical performance studies related to snoring or OSA reduction.

Therefore, I cannot provide the requested information as it is not present in the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance for clinical outcomes.
2. Sample size for a test set for clinical performance or its provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method.
5. Multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human readers with/without AI assistance.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used for clinical efficacy (e.g., expert consensus, pathology, outcomes data).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The "studies" mentioned are in vitro technical tests for mechanical integrity and packaging, not clinical performance studies in humans.

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