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The DaSoft Advanced Dental Appliance is an intraoral device designed to be worn during sleep to reduce snoring. The device includes a manually adjustable tongue sleeve to position the tongue and surrounding tissues forward in order to increase the patient's pharyngeal space, improving the ability to exchange air and decreases air turbulence. The device is manufactured using only medical grade ethylene vinyl acetate (EVA) polymer.

AI/ML Overview

The provided text describes the DaSoft Advanced Dental Appliance, an intraoral device intended to reduce snoring. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria related to its clinical efficacy.

Therefore, the information requested regarding acceptance criteria, device performance, sample size, ground truth, expert opinions, and comparative effectiveness studies for the device's efficacy in reducing snoring is not available in the provided document. The document primarily focuses on biocompatibility and material properties as part of its non-clinical testing to establish substantial equivalence.

Here's a breakdown of what can be extracted and what is missing:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Biocompatibility/Material Testing: (Implicit from ISO standards)
  - Cytotoxicity: Material should not be cytotoxic.
  - Irritation: Material should not cause irritation.
  - Sensitization: Material should not cause sensitization.
  - Tensile Properties: Tested per ISO 527-1,2:2012.
  - Flexural Properties: Tested per ISO 178:2010/Amd.1:2013.
  - Water Absorption Properties: Tested per ISO 62:2008.
- Reported Device Performance (for Biocompatibility/Material Testing):
  - The DaSoft Advanced Dental Appliance material (EVA) was concluded to be biocompatible per ISO 10993 (cytotoxicity, irritation, and sensitization).
  - Tensile properties, flexural properties, and water absorption properties were tested as per the specified ISO standards.
  - Specific values or numerical results of these tests (e.g., tensile strength, flexural modulus, water absorption percentage) are not provided in this summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available for clinical efficacy in this document.
- For biocompatibility/material testing, sample sizes are typically determined by the specific ISO standard, but the specific numbers are not stated in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/available for clinical efficacy in this document. The biocompatibility testing relies on standardized laboratory methods rather than expert interpretation of clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/available for clinical efficacy in this document.
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:
- No, this is not an AI-assisted device, and no MRMC study is mentioned for its clinical efficacy.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available for clinical efficacy in this document.
- For biocompatibility/material testing, the ground truth is established by adherence to ISO standards and laboratory-derived results.
The sample size for the training set:
- Not applicable/available. This is not a machine learning device, and no clinical training set is mentioned.
How the ground truth for the training set was established:
- Not applicable/available.

Summary of available information from the document:

The 510(k) summary focuses on demonstrating that the DaSoft Advanced Dental Appliance is substantially equivalent to existing predicate devices (MPowRx K081965 and SnoreRx K112205), particularly in terms of:

Classification and Product Code: Class II, 21 CFR 872.5570, LRK (same as predicates).
Intended Use: Intraoral device for snoring (same as predicates).
Indications for Use: To reduce snoring in adult patients aged 18 years or older (no differences from predicates).
Mode of Action: Although the device uses a tongue sleeve while one predicate uses tongue retention by suction and the other mandibular repositioning, the document states the "Mechanism of action for snoring reduction is equivalent."
Materials: Medical grade Ethylene vinyl acetate (EVA) polymer. This is justified as commonly used in dental and consumer products, with biocompatibility tested per ISO 10993.
Design: Custom fitted intraoral device. Justified as efficacious (based on predicate equivalence) and materials characterized as substantially equivalent.
Sterility: Non-sterile (same as predicates).
Biocompatibility: Tested per ISO 10993 and concluded to be biocompatible (cytotoxicity, irritation, sensitization).
Performance Testing (Non-Clinical): Tested for tensile properties (ISO 527-1,2:2012), flexural properties (ISO 178:2010/Amd.1:2013), and water absorption properties (ISO 62:2008).

The document does not provide details of clinical studies or trials demonstrating the efficacy of the DaSoft Advanced Dental Appliance in reducing snoring against specific acceptance criteria. Its clearance is based on substantial equivalence, which often means demonstrating that device characteristics (design, materials, intended use, mode of action, performance) are sufficiently similar to a legally marketed predicate device that no new questions of safety or effectiveness are raised.

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