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The DaSoft Advanced Dental Appliance is indicated to reduce snoring in adult patients age 18 years or older.

The DaSoft Advanced Dental Appliance, previously cleared under K172991, repositions the tongue and related tissues anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence; a causative factor in snoring. The device is manufactured using medical grade ethylene vinyl acetate (EVA) polymer, which is a material that has a "generally recognized as safe" (GRAS) designation from FDA.

The provided text is a 510(k) summary for the Advanced Dental Appliance, an anti-snoring device. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices based on:

• Intended Use: Reducing snoring in adult patients aged 18 or older.
• Mechanism of Action: Repositioning the tongue and related tissues anteriorly to increase pharyngeal space, reduce resistance, and decrease turbulent airflow.
• Technological Characteristics: Similar design, materials (medical grade ethylene vinyl acetate (EVA) polymer), and functionality (boil-and-bite method for customization).
• Nonclinical Testing: Material property testing (flexural modulus and strength, stress and strain at break, water absorption) on the tray material, meeting device specifications.
• Biocompatibility Testing: Cytotoxicity, irritation, and sensitization tests according to ISO 10993, showing the device is biocompatible.
• Usability Testing: A study following FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices," demonstrating that OTC consumers can appropriately prepare, fit, and adjust the device.

Since the document is a 510(k) summary for a Class II device (Intraoral device for snoring, 21 CFR 872.5570), the primary approach for market clearance is demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a detailed clinical study with specific acceptance criteria as might be seen for novel or higher-risk devices.

Therefore, I cannot provide the requested information such as a table of acceptance criteria, device performance relative to those criteria, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance, as this type of information is not present in the provided text.

The "study" mentioned is the usability study, which focused on user comprehension and ability to use the device, not on its clinical efficacy in reducing snoring, or a comparison to specific performance metrics for snoring reduction.

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