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SNOR LOCK is indicated for use for adults 18 years and above as an aid in the reduction of snoring during hours of sleep.

The SNOR LOCK is an oral appliance comprised of an upper and lower tray constructed in one piece. The trays engage with the maxillary and mandibular dentition and the device maintains an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion.

The provided text is a 510(k) summary for the medical device "SNOR LOCK." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific performance acceptance criteria for its intended clinical use (reduction of snoring).

Therefore, I cannot create the requested table of acceptance criteria and reported device performance from the provided text. The document describes non-clinical testing performed to ensure safety and basic functionality and compares the device's characteristics to a predicate device, but it does not include a clinical study with defined acceptance criteria for snoring reduction.

Here's why I cannot fulfill all parts of your request based on the provided text, and what information is available:

Information NOT Available in the Provided Text:

• A table of acceptance criteria and the reported device performance for snoring reduction: The document does not describe a clinical study measuring the effectiveness of SNOR LOCK in reducing snoring against specific, quantifiable acceptance criteria. It focuses on demonstrating equivalence to a predicate device.
• Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) for a clinical effectiveness study: No such clinical effectiveness study is detailed.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such clinical effectiveness study is described.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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. This device is an anti-snoring intraoral device, not an AI-assisted diagnostic tool.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical effectiveness study: Not applicable.
• The sample size for the training set, and how the ground truth for the training set was established for a clinical effectiveness study: Not applicable.

Information Available related to "Acceptance Criteria" implicitly for demonstrating device safety and basic functionality:

The document mentions Non-Clinical Testing with "preset test criteria." These are primarily for biocompatibility and material safety, not clinical efficacy in reducing snoring.

• 1. A table of acceptance criteria and the reported device performance (for non-clinical testing):

• 2. Sample sized used for the test set and the data provenance: Not explicitly stated for each non-clinical test, but "test articles" were used. Data provenance generally refers to the testing institution's method for these non-clinical tests.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable for non-clinical lab tests.
• 4. Adjudication method: Not applicable for non-clinical lab tests.
• 5. MRMC comparative effectiveness study: Not applicable.
• 6. Standalone performance: The non-clinical tests assess the device's inherent properties and performance against specified standards, which can be seen as "standalone" from human interaction in a clinical setting.
• 7. The type of ground truth used:
  • For Biocompatibility: Established international standards (ISO 10993 series) define the ground truth for toxicity, genotoxicity, sensitization, etc.
  • For Physical/Chemical Properties: Internal methods and referenced standards for appearance, dimension, weight, pH, etc.
• 8. The sample size for the training set: Not applicable; this device does not use an AI/ML training set.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a medical device (SNOR LOCK) through non-clinical testing and comparison to a predicate device, rather than a report on a clinical study proving specific performance acceptance criteria for snoring reduction.

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