(194 days)
The REST EAZY Appliance is intended for use in adult patients for the reduction of snoring and mild to moderate obstructive sleep apnea. The REST EAZY Appliance is worn while sleeping to support the lower jaw in a forward position as prescribed by the dentist. The appliance is removable by the patient.
The proposed REST EAZY Appliance device consists of an upper and lower acrylic splint, custom fabricated to the patient's teeth. The splints are connected to each other via the REST EAZY adjustable Herbst style mechanism that orients the jaw in a predetermined relationship. These devices function as a mandibular repositioner, which increases the pharyngeal space. An enlarged pharyngeal space assists the patient with improved air exchange. The device is custom fit for each patient, as prescribed by the dentist.
The provided text is a 510(k) Summary for the REST EAZY Appliance. It focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data as would be found for complex AI/ML-driven devices. Therefore, much of the requested information regarding acceptance criteria, performance metrics, and clinical study details (like sample size for test sets, expert qualifications, and adjudication methods) is not applicable or not available in this specific document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present specific quantitative acceptance criteria or performance metrics in a table format for the device's efficacy in reducing snoring or treating obstructive sleep apnea. Instead, it relies on demonstrating substantial equivalence to an already cleared predicate device (Specialty Appliance Works, Inc.'s Acrylic Splint Herbst Appliance).
The reported "performance" is implicitly tied to this substantial equivalence; the new device is expected to perform similarly to the predicate.
| Acceptance Criteria Category | Acceptance Criteria (from predicate equivalence) | Reported Device Performance (by equivalence) |
|---|---|---|
| Intended Use | Reduction of snoring and mild to moderate obstructive sleep apnea in adult patients. Support lower jaw in forward position while sleeping. Removable by patient. | Same as predicate. |
| Technological Characteristics | Matching fundamental scientific technology, design, and materials of the predicate device. | Device consists of customized maxillary and mandibular form-fitting arches with an adjustable Herbst-style mechanism to support jaw movement. Materials are stainless steel (304 or 316) and dental acrylic (Variflex®). |
| Biocompatibility | No new materials, materials established as biocompatible for permanent external communicating (mucosa) contact. | Utilizes stainless steel and dental acrylic, identical to predicate. Biocompatibility established for Variflex (K033632). |
| Physical Properties | Similar physical properties as the Variflex material used in the predicate. | Testing conducted on Variflex (K033632) material for ultimate tensile strength, Young's modulus, hardness (Shore D), water sorption, and water solubility. (Specific values not provided in this summary). |
| Safety/Risk | Risks are identified and addressed through contraindications, warnings, precautions, and instructions for use, similar to the predicate. | Risk analysis performed; no significant new risks identified beyond those associated with mandibular advancement devices (e.g., TMJ soreness, soft tissue soreness, dentition complications). |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission is based on demonstrating substantial equivalence through comparison of technological characteristics and materials to a predicate device, not through a new clinical performance study. The data provenance mentioned refers to the biocompatibility and physical properties of the materials, which were established through prior testing of a cleared component (Variflex K033632).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new clinical "test set" requiring expert ground truth establishment for diagnostic performance is described in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. As no clinical test set requiring expert adjudication for ground truth is described.
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-assisted device. The device is a physical intraoral appliance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this type of 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the FDA's prior clearance of the predicate device based on its established safety and effectiveness. The performance of the new device is inferred to be similar due to its substantially equivalent characteristics.
8. The sample size for the training set:
- Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not a machine learning device.
§ 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.”