(32 days)
Silent Nite Sleep Appliance with the Glidewell Hinge is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older. It is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.
The subject device, Silent Nite® Sleep Appliance with the Glidewell Hinge™, is a mandibular advancement device (MAD). It holds the mandible in a protrusive position to increase the patient's ability to exchange air and decrease air turbulence, thus improving airflow during sleep.
The subject device, Silent Nite® Sleep Appliance with the Glidewell Hinge™, consists of upper and lower trays, and an engaging mechanism made of stainless-steel, which is the Glidewell hinge. Optional orthodontic (elastic) bands are provided as accessories. The trays consist of a soft polyurethane inner layer that provides patient comfort and a hard polyester outer layer for durability. The hinge is adjustable by turning an inner adjustment screw with a hex driver, enabling the amount of mandibular advancement prescribed by the clinician. The design allows for the advancement of the mandible to be adjusted (increased) in 0.25 mm increments up to 10 mm.
The subject device, Silent Nite® Sleep Appliance with the Glidewell Hinge™, is customized to conform to the patient's upper and lower dentition based on the clinician's prescription. Upon receipt of the prescription, models for the trays are made and used during the thermoforming fabrication of the upper and lower trays.
The provided text describes the 510(k) summary for the "Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report with acceptance criteria and performance data for a novel device. As such, several of the requested categories are not applicable or not explicitly stated in the provided text.
Here is the information that can be extracted and a note on what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum and incremental adjustment for the hinge | The device allows for advancement of the mandible in 0.25 mm increments up to 10 mm. Specific performance not quantified against a target value, but stated as a feature. |
| Retention strength of the hinge | Not explicitly quantified. "Retention strength of the hinge" was a test conducted. |
| Laser weld inspection | Not explicitly quantified. "Laser weld inspection" was a test conducted. |
| Telescopic rod movement test | Not explicitly quantified. "Telescopic rod movement test" was a test conducted. |
| Hinge placement/positioning is correct | Met: Test samples ensured this criterion was met. |
| Device fits and retains to the model | Met: Test samples ensured this criterion was met. |
| Hinge is attached well to the trays | Met: Test samples ensured this criterion was met. |
| Device's final finish is smooth and free of roughness or burs | Met: Test samples ensured this criterion was met. |
Note: The document states that the results of verification activities "confirmed that the design of the subject device, meet all the predetermined criteria according to the design specifications." However, the specific quantitative acceptance criteria (e.g., minimum retention strength in Newtons) and the corresponding quantitative performance values are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document mentions "test samples were made using the standard fabrication process," but does not provide the number of units tested for each verification activity.
- Data Provenance: Not explicitly stated. The tests were "conducted by Prismatik Dentalcraft, Inc." It is assumed to be internal testing. The data is likely retrospective pertaining to the design and manufacturing processes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the verification tests were for design specifications (e.g., mechanical functionality, fit, finish), not for clinical diagnostic accuracy or efficacy requiring expert ground truth establishment in the traditional sense of a clinical study.
4. Adjudication method for the test set
- Not applicable for the type of design verification tests performed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No, a MRMC comparative effectiveness study was not gedaan. The study described is a design verification study, not a clinical efficacy study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical intraoral appliance, not an algorithm or software. The "standalone" concept refers to AI performance, which is not relevant here.
7. The type of ground truth used
- The "ground truth" for the design verification tests was based on predetermined design specifications (e.g., specific dimensions, functional requirements, material properties, quality control standards). For example, the device either did or did not achieve the 0.25mm incremental adjustment, or the hinge either passed or failed the laser weld inspection according to predefined criteria.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML model 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.”