Search Results

SOMNOS ANTI-SNORING MOUTH GUARD is an over-the-counter mouthguard intended for use in adult persons 18 years of age or older as an aid for the reduction of snoring.

SOMNOS ANTI-SNORING MOUTH GUARD is comprised of a mouthguard, a spatula and a storage case. The mouthguard is a self-fitting adjustable Mandibular Advancement Device (MAD) removable intraoral anti-snoring device used to reduce nighttime snoring in adult persons 18 years of age or older. SOMNOS ANTI-SNORING MOUTH GUARD consists of two customized prefabricated single-piece trays that conform to the patient's dentition in the upper and lower jaws. The device functions as a mandibular anterior repositioner, which acts to increase the user's pharyngeal space, resulting in the improvement of the ability to exchange air during sleep. SOMNOS ANTI-SNORING MOUTH GUARD, while in situ. moves the lower jaw forward and helps reduce the likelihood of snoring. It is intended to be worn while sleeping. The supplied spatula is used to separate the SOMNOS ANTI-SNORING MOUTH GUARD. SOMNOS ANTI-SNORING MOUTH GUARD is conformable to wear, and it can be self-fitted by the 'boil and bite' method (when heated the device conforms to person's teeth) and allows slight adjustment of the anterior positioning of the jaw to the person's comfort.

SOMNOS ANTI-SNORING MOUTH GUARD is constructed of two (2) preformed and fixed single piece trays composed of Thermoplastic resin Propylene Elastomer (TPE) material, specifically Ethylene-Vinyl-Acetate for the moldable part and Polycarbonate for the rigid part of the device. The spatula and storage case are composed of 100% Polypropylene. The materials in Somnos are commonly used in other 510(k) cleared dental mouth guards for bruxism and antisnoring. The three components (mouthguard, spatula and storage case) are manufactured by injection molding. They are non-flavored and have no color additives.

SOMNOS ANTI-SNORING MOUTH GUARD is provided in one model/size, is reusable by a single individual who is at least eighteen (18) years of age and is supplied as non-sterile.

Each box of SOMNOS ANTI-SNORING MOUTH GUARD is supplied with the following items:

• . (1) Anti-snoring Mouthguard
• . (1) Spatula
• (1) Storage case ●
• (1) Instructions for Use ●

This document is a 510(k) Premarket Notification for the SOMNOS ANTI-SNORING MOUTH GUARD. It primarily demonstrates substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria for a novel device. Therefore, many of the requested fields are not directly applicable or are not explicitly stated in the provided text.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific quantitative acceptance criteria (e.g., minimum hardness values, maximum water sorption) for the functional performance tests. Instead, it states that these tests were conducted "in accordance with FDA Recognized Consensus Standard, ISO 20795-2 Dentistry - Base polymers - Part 2: Orthodontic base polymers." The implication is that the device met the requirements of this standard, but the specific numerical results and the acceptance thresholds are not detailed.

Similarly, for biocompatibility, tests were conducted "in accordance with International Standard ISO 10993-1:2009 Biological evaluation of medical devices – Part 1 Evaluation and testing within a risk management process and FDA's Guidance Document." The conclusion is that the materials are "Biocompatible" and that the tests performed "demonstrated that the SOMNOS ANTI-SNORING MOUTH GUARD is substantially equivalent to the predicate device."

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

• Sample Size for Test Set: Not explicitly stated for any of the performance or biocompatibility tests. The document refers to "the SOMNOS ANTI-SNORING MOUTH GUARD" as if referring to representative samples.
• Data Provenance: The tests are described as being "conducted on SOMNOS ANTI-SNORING MOUTH GUARD," implying laboratory testing of the manufactured device. The country of origin of the data is not specified. It is laboratory data, not patient data (retrospective or prospective).

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

Not applicable. This submission is based on engineering and biocompatibility testing against recognized standards, not on human expert evaluation for "ground truth" in clinical performance. "Ground truth" in this context would be the pass/fail criteria of the international standards.

4. Adjudication method for the test set

Not applicable, as no human expert adjudication on "ground truth" was performed. Compliance to standards is typically assessed by laboratory personnel.

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. This is not an AI/imaging device. It's a physical medical device (intraoral mouthguard). No clinical studies, let alone MRMC studies, were performed or provided.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used

The "ground truth" for the performance and biocompatibility tests is the compliance with the established international consensus standards (ISO 20795-2 and ISO 10993 series). The device had to demonstrate properties that meet the requirements outlined in these standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Ask a specific question about this device

Bright Guard is a mouth guard intended to protect against grinding and clenching. For over-the-counter use.

Bright Guard is comprised of a mouth guard, spatula and storage case. The mouth guard is an over-the-counter, flexible and moldable one-piece dental mouth guard, which is used as a barrier between teeth for individuals who grind their teeth. Bright Guard mouth guard is intended to be worn while sleeping. The mouth guard material is conformable to wear, and it can be self-fit by the 'boil and bite' method (submerging in hot water to make the material malleable to fit on the upper teeth of the oral cavity). Bright Guard mouth guard is constructed of 100% Thermoplastic resin Propylene Elastomer (TPE) material (ethylene-vinyl-acetate) [Elvax]. When heated it forms to the individual's teeth. It is non-flavored and has no color additives. Bright Guard does not contain Bisphenol A (BPA) or phthalates and is free of natural rubber latex. The spatula and storage case are composed of 100% Polypropylene. The materials in Bright Guard are used in various other 510(k) cleared dental mouth guards. The three components (mouth guard, spatula and storage case) are manufactured by injection molding. Bright Guard mouth guard Is provided in one model/size, is reusable by a single individual at least eighteen (18) years of age and is supplied as non-sterile.

The provided text is a 510(k) Summary for a medical device called "Bright Guard," a mouth guard intended to protect against grinding and clenching. It outlines the device's characteristics, its comparison to predicate devices, and the non-clinical performance data used to demonstrate substantial equivalence.

However, the provided document does not describe acceptance criteria for a study, nor does it detail a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device submission (e.g., accuracy, sensitivity, specificity, or human performance improvement with AI assistance).

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices based on material composition, functional design, intended use, and non-clinical performance tests (biocompatibility and functional tests). There is no mention of an AI algorithm, a test set for AI, ground truth establishment by experts, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text does not contain such information for an AI/ML device.

The document explicitly states:

• "There were no clinical tests performed or provided in this submission." This means no human subject studies were conducted to assess clinical efficacy or performance.
• The performance data provided relates to "functional non-clinical performance tests" (Hardness, Water Sorption and Solubility, Spatula & Mouth guard Boiling/Cooling Water Testing) and "biocompatibility assessment" (Cytotoxicity, Skin Sensitization, Oral Mucosal Irritation). These are material and safety tests, not performance metrics like accuracy, sensitivity, or human-AI reader improvement.

Based on the provided information, the device is a simple "boil and bite" mouth guard, not an AI-powered device. Therefore, the questions related to AI/ML device testing (e.g., sample size for test/training sets, experts for ground truth, MRMC studies, effect size of AI assistance) are not applicable to this submission.

Ask a specific question about this device