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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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Intended to reduce or alleviate snoring, mild to moderate Obstructive Sleep Apnea (OSA) while sleeping in adults.

DS8 consists of two trays worn on the maxilla and mandible. The device is manufactured at Slow Wave facilities using additive manufacturing, specifically on a Formlabs 3D Printer utilizing stereolithography (SLA) using biocompatible material.
The trays are designed to be an exact custom fit by a trained dental technician, using a 3Shape intraoral scanning device, or comparable intraoral scanner such as the iTero, or Cerec, registering one's full impressions of the upper teeth, lower teeth. A bite scan registration with a gap (typically 8 mm), which is a crucial design feature. The gap results from the design of the lower and upper trays. The upper and lower trays, the molars, premolars, and canines, are covered by the device. However, the lateral or central incisors are not covered, which effectively leaves eight teeth (four maxillary incisors and four mandibular incisors) uncovered. The trays are shaped like arch because the covered portion of the device is connected to each other by two palatal bands one connecting the upper left and upper tray, and the other connecting the lower tray.

Additionally, the trays are built with ramps that guide the mandible forward and downward, thus maintaining advancement, enlarging the airway, allowing more room for the tongue to migrate forward naturally. The vertical opening of the jaw is not fixed in a single position. DS8 is a traction-based mandibular repositioning device that allows nasal and/or oral breathing.

The provided text is a 510(k) Premarket Notification summary for the Slow Wave DS8 device. It evaluates the substantial equivalence of the Slow Wave DS8 to legally marketed predicate devices, specifically the Panthera D-SAD and The NightBlocks Appliance.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical testing (e.g., clinical trials or performance assessments with ground truth and expert reviews). This type of detailed study showcasing device performance against defined acceptance criteria, often seen with AI/ML-driven medical devices, is not part of this 510(k) submission.

The 510(k) process for this device relies on demonstrating substantial equivalence to existing predicate devices, meaning it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety and effectiveness. The document primarily focuses on comparing the Slow Wave DS8's features and operating principles to its predicates.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on claims of substantial equivalence rather than quantifying direct device performance against specific metrics.
2. Sample size used for the test set and the data provenance: No "test set" in the context of an AI/ML performance study is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no mention of a test set requiring expert-established ground truth.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this device is a physical intraoral device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document explicitly states:

• "Animal or Human testing: No Animal or Human testing was conducted on DS8 device." This confirms that there were no clinical studies or human/animal trials to generate performance data for this submission. The biocompatibility assessment was performed on the material itself by Formlabs, not on the finished device in biological systems for efficacy.

In summary, this 510(k) submission primarily addresses the substantial equivalence of a physical medical device (intraoral device for snoring/sleep apnea) to predicate devices based on shared intended use and technological similarities, rather than demonstrating performance against specific acceptance criteria through empirical studies with test sets, ground truth, or expert evaluations.

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