(172 days)
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."
| Test Category | Acceptance Criteria (Implied from Standard/Guidance) | Reported Device Performance Summary (Implicit) |
|---|---|---|
| Functional Performance Tests: | ||
| Hardness | Conforms to ISO 20795-2 | Performed in accordance with ISO 20795-2. Outcomes are "acceptable" and support substantial equivalence. |
| Water Sorption | Conforms to ISO 20795-2 | Performed in accordance with ISO 20795-2. Outcomes are "acceptable" and support substantial equivalence. |
| Water Solubility | Conforms to ISO 20795-2 | Performed in accordance with ISO 20795-2. Outcomes are "acceptable" and support substantial equivalence. |
| Spatula & Mouth guard Boiling/Cooling Water Testing | Conforms to ISO 20795-2 | Performed in accordance with ISO 20795-2. Outcomes are "acceptable" and support substantial equivalence. |
| Flexural Strength | Conforms to ISO 20795-2 | Performed in accordance with ISO 20795-2. Outcomes are "acceptable" and support substantial equivalence. |
| Flexural Modulus | Conforms to ISO 20795-2 | Performed in accordance with ISO 20795-2. Outcomes are "acceptable" and support substantial equivalence. |
| Fracture Toughness | Conforms to ISO 20795-2 | Performed in accordance with ISO 20795-2. Outcomes are "acceptable" and support substantial equivalence. |
| Optical Microscopy (OM) | Conforms to ISO 20795-2 | Performed in accordance with ISO 20795-2. Outcomes are "acceptable" and support substantial equivalence. |
| Biocompatibility Tests: | ||
| In Vitro Cytotoxicity | Conforms to ISO 10993-5 | Performed in accordance with ISO 10993-5. Device declared "Biocompatible" and supports substantial equivalence. |
| Skin Sensitization (0.9% Sodium Chloride) | Conforms to ISO 10993-10 | Performed in accordance with ISO 10993-10. Device declared "Biocompatible" and supports substantial equivalence. |
| Skin Sensitization (Sesame Oil) | Conforms to ISO 10993-10 | Performed in accordance with ISO 10993-10. Device declared "Biocompatible" and supports substantial equivalence. |
| Oral Mucosal Irritation (0.9% Sodium Chloride) | Conforms to ISO 10993-10 | Performed in accordance with ISO 10993-10. Device declared "Biocompatible" and supports substantial equivalence. |
| Oral Mucosal Irritation (Sesame Oil) | Conforms to ISO 10993-10 | Performed in accordance with ISO 10993-10. Device declared "Biocompatible" and supports substantial equivalence. |
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.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”