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The Slow Wave DS8 is indicated for the treatment of sleep bruxism and as an aid in the treatment of associated tension/migraine type headaches in adults over the age of 18.

The Slow Wave DS8 is an intraoral appliance designed to safeguard teeth and restorations from the impacts of bruxism forces. It is a patient-specific device that consists of two trays worn on the maxilla and mandible conforming to the upper or lower teeth. This device acts as a physical divide between upper and lower tooth surfaces, preventing damage induced by bruxism activities such as grinding and clenching. Additionally, it eases discomfort associated with muscle tension and headaches. Multiple tray designs are available for this purpose, each offering distinct levels of functionality and suitability based on the patient's requirements. The device is manufactured using additive manufacturing, specifically on a Formlabs 3D Printer utilizing stereolithography (SLA) using biocompatible material.

The provided document does not contain information about acceptance criteria for device performance or any study conducted to prove the device meets such criteria.

The document is a 510(k) premarket notification for the Slow Wave DS8 device, which is an intraoral appliance indicated for the treatment of sleep bruxism and associated tension/migraine type headaches. The core of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific quantitative acceptance criteria through clinical studies.

The document explicitly states in section 1.8.1 "Clinical Studies": "Clinical testing was not necessary for the demonstration of substantial equivalence." This means there was no study conducted to measure and report device performance against acceptance criteria.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance.
• Sample size for the test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results of a standalone algorithm performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document focuses on comparing the Slow Wave DS8 to a predicate device (Luco Hybrid OSA Appliance K160477) and reference devices (Formlabs Dental LT Clear V2 K222061 and Slow Wave DS8 K191320) based on characteristics like classification, product code, indications for use, prescription status, target population, use of device, principle of operation, features, material properties, materials, manufacturing method, and sterility. The "Performance Data" section (1.8) only states that "Performance requirements were determined through an assessment of the physical properties of the device," implying engineering or material testing, not clinical performance data against specific acceptance criteria relevant to the device's therapeutic claims.

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