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The Serena Sleep Night Guard/Occlusal Appliance is a removable medical device that is fitted to the patient's mouth and is intended to protect teeth and restorations against the forces of bruxism and alleviate temporomandibular joint, jaw, and muscle and tension headache pains.

The Serena Sleep Night Guard/Occlusal Appliance is a custom-made intraoral device used for protecting teeth and restorations against the forces of bruxism and alleviating temporomandibular joint, jaw, and muscle and tension headache pains.

The provided text is an FDA 510(k) summary for the Serena Sleep Night Guard, a medical device. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based diagnostic or prognostic system.

The submission is for a physical medical device (a night guard), and the "performance testing" section refers to bench testing for physical properties like flexural strength, water sorption, and durability, and states that no clinical testing was deemed necessary due to the similarity to the predicate device.

Therefore, I cannot extract the information required to answer your prompt from the provided text, as it specifically asks for details related to AI/algorithm performance and clinical validation studies common in the context of AI-driven medical devices.

Here's why and what's missing:

• Acceptance Criteria for AI Performance: The document does not mention any AI, algorithms, or software intended for diagnostic or prognostic purposes. Thus, there are no acceptance criteria related to sensitivity, specificity, AUC, or other metrics typically used for assessing AI performance in a clinical setting.
• Study Proving Device Meets Criteria: Since there's no AI component, there's no study described that evaluates AI performance against clinical outcomes or expert labels. The document explicitly states "no Clinical Testing were deemed necessary."
• Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC, Standalone Performance, Type of Ground Truth, Training Set Size/Ground Truth: All these points are relevant to the validation of AI/ML models in medical devices. As the Serena Sleep Night Guard is a physical device analogous to a 3D-printed appliance, these concepts do not apply to its regulatory submission as described.

In summary, the provided document is a 510(k) for a physical medical device and does not contain the information required to address your prompt about AI/algorithm acceptance criteria and validation studies.

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