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The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring.

The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring. The STZ advances and holds the lower jaw forward during sleep which enlarges and stiffens the airway to alleviate or reduce snoring. The STZ attaches to both upper and lower teeth which maintains a properly opened airway. The STZ utilizes a biocompatible thermoplastic mouthpiece material to treat snoring. The raw material is ethylene-vinyl acetate (EVA). The STZ uses the common boil and bite technique familiar to athletes who heat and mold their mouth guard to fit their teeth. In this process the user softens the mouthpiece in hot water according to detailed directions provided with packaging. The user bites into the softened plastic and compresses the softened material to their teeth and gums while holding the jaw slightly forward until the material cools and stiffens. After cooling, the device maintains its shape and is used to hold the jaw open and forward during sleep to alleviate or reduce snoring.

The provided document is a 510(k) Premarket Notification from the FDA regarding the "SleepTight Mouthpiece STZ." This document primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a clinical study or performance data like those typically found in a clinical trial report for AI/machine learning devices.

Therefore, this document does not contain the information requested in your prompt regarding acceptance criteria and the detailed study that proves the device meets those criteria.

The document states:

• "Additional non-clinical testing was not performed for this submission as the performance of the STZ is identical to the previously cleared primary predicate STM." (Page 7)
• "The STZ, Substantial equivalence is based on non-clinical data as it relates to the historical use of cleared intraoral devices that reposition the jaw forward to alleviate or reduce snoring and to historical and ongoing documented scientific research confirming mandibular advancement devices to treat snoring." (Page 7)
• "Since the materials and methods of manufacture of the STZ are identical to the materials utilized in the STM K132506 predicate, no additional biocompatibility testing is provided. The STZ and STM are identical in terms of biocompatibility." (Page 8)

The core argument for clearance is that the SleepTight Mouthpiece STZ is technologically identical to a previously cleared prescription device (STM) and functionally similar to other cleared over-the-counter (OTC) devices (SnoreRx, ZQuiet), with the key difference being an update to labeling and inclusion of a "STOPBang" questionnaire to make it suitable for OTC use. The FDA's review in this context is about confirming this substantial equivalence, not evaluating new performance data from a dedicated clinical study against pre-defined acceptance criteria as would be done for a novel AI/ML device.

Therefore, it is impossible to extract the requested information from the provided text. The prompt's questions pertain to a type of study and data not present in this 510(k) submission.

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Snorer's Friend is an intra-oral mandibular advancement device used during sleep to reduce snoring and treat mild to moderate Obstructive Sleep Apnea (OSA) in adults.

The 'Snorer's Friend' is an intra-oral mandibular advancement device used during sleep to reduce snoring by advancing the lower jaw and thereby minimizing air obstruction and turbulence. It advances the lower jaw and tongue forward so the airway will remain open during sleep. The device is fitted to the patient by, or under the direction of, physicians (e.g., ENT doctors, sleep lab doctors or dentists) or their trained medical staff by immersing it in boiling water for approximately 17 seconds. Once removed from the hot water, it is very gently rotated to allow excess water to run off. Snorer's Friend is custom fitted to the upper and lower teeth, in a similar fashion to an athletic mouth guard. When boiled, the material softens which allows the device to be molded to the shape of the patient's teeth. To prepare for the fitting, the spatula provided is used to place the device in boiled water for 17 seconds. Holding the mouth of the patient open and the lower jaw forward, the physician or their trained medical staff places the device in the mouth and the patient bites down firmly. The device is then placed in cold water. The Snorer's Friend is simple to fit and does not require impressions or lab-fabrication. As such, it is a more economical and timesaving alternative to more costly labfabricated mandibular advancement devices. Snorer's Friend intra-oral mandibular advancement devices are only to be fitted/re-fitted by, or under the direction of, physicians (e.g., ENT doctors, sleep lab doctors or dentists) or their trained medical staff. The patient should undergo a comprehensive oral health assessment by a dentist before the device is fitted to the patient. The maximum mandibular advancement to be performed with this device is 5 mm.

This document describes the Snorer's Friend, an intra-oral mandibular advancement device, and its substantial equivalence to a predicate device. It does not contain information about an AI-based device, nor details of acceptance criteria or a study proving that an "AI-device" meets those criteria. Therefore, most of the requested information cannot be extracted.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SomnoGuard) for a traditional medical device (Snorer's Friend), not an AI-enabled one. As such, information regarding acceptance criteria, studies for AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable or present in this document.

However, some relevant information regarding the device and its comparison to the predicate is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the context of measurable performance metrics typically associated with AI devices (e.g., sensitivity, specificity, AUC). Instead, substantial equivalence is based on similar intended use, design, technology, materials, and performance characteristics compared to a predicate device.

The table below summarizes the comparison presented between the Snorer's Friend and its predicate, which implicitly serves as the "performance" benchmark for establishing equivalence.

2. Sample size used for the test set and the data provenance:

• Not applicable as this is not an AI-device study. The equivalence is based on design and material comparisons, not a clinical "test set" in the context of an AI algorithm.
• The document states: "Snorer's Friend has similar design, technology, and indications for use as the predicate SomnoGuard and therefore Section 8 - Clinical Data is not applicable."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is not an AI-device study requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) 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:

• No, this was not done as it is not an AI-enabled device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• No, this was not done as it is not an AI-enabled device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not applicable. For this type of device, "ground truth" would relate to its physical properties, biocompatibility, and user-fitting success, which are addressed through design verification and validation activities and comparison to the predicate.

8. The sample size for the training set:

• Not applicable as this is not an AI-device study.

9. How the ground truth for the training set was established:

• Not applicable as this is not an AI-device study.

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