(100 days)
Silent Nite Sleep Appliance with the Glidewell Hinge is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 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 Silent Nite Sleep Appliance with the Glidewell Hinge is a mandibular advancement device. 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 device consists of upper and lower trays, which are fabricated using a biocompatible dual-layered thermoplastic material, and an engaging mechanism, which is the Glidewell Hinge (biocompatible medical grade stainless steel bars), and band lugs and hooks for attaching the optional orthodontic (elastic) bands, which 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 or decreased) in 0.25 mm increments up to 10 mm. The orthodontic bands accessories are used to aid in holding the mouth closed. The end result, a forward position of the jaw, is the same as the predicate, however, the method of action of the predicate device and subject device are slightly different. Silent Nite Sleep Appliance with the Glidewell Hinge's method of action is identical to the Reference device and both use orthobands. Without orthobands, the patient's mouth can open during sleep which allows the tongue to fall back into the airway. The orthobands help keep the mouth closed to avoid this. With just a slight protrusion, the orthobands can be placed on the provided hooks. More protrusion requires the orthoband to be placed on the forward hook and the band lug. The device 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 difference between the Silent Nite Sleep Appliance with the Glidewell Hinge and the Primary Predicate Silent Nite sl is the mechanism connecting the trays: The new device's stainless steel hinge allows adjustment within the mechanism, while the Predicate's adjustment requires changing the plastic connectors. This is a non-sterile device, to be used only by the single patient for whom it is custom-designed and is to be worn during sleep.
The provided text is a 510(k) Summary for a medical device called the "Silent Nite Sleep Appliance with the Glidewell Hinge." It describes the device, its intended use, and how it compares to a predicate device to establish substantial equivalence for FDA clearance.
Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them, primarily focusing on the engineering and material performance rather than clinical efficacy studies, as this is a 510(k) submission for a physical device:
Acceptance Criteria and Reported Device Performance
The acceptance criteria detailed in the document are primarily related to the device's functional integrity, fit, and material biocompatibility. Clinical efficacy (e.g., reduction in AHI) is established through the similarity to the predicate device, not through new clinical trials described here.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Assessment Method |
|---|---|---|
| Functional Attributes | Mandibular advancement function correct | - Verification testing conducted by Prismatik Dentalcraft, Inc. |
- Device design allows for advancement to be adjusted (increased or decreased) in 0.25 mm increments up to 10 mm. This indicates the function works as intended. |
| | Maximum hinge displacement (mm) correct | - Verification testing conducted by Prismatik Dentalcraft, Inc. - Specific maximum displacement (up to 10mm) is stated, implying it meets this range. |
| | Hinge placement/positioning correct | - Verification testing conducted by Prismatik Dentalcraft, Inc. |
| | Device fits and retains to the model | - Validation testing showed acceptable performance. - Customized to conform to the patient's upper and lower dentition based on clinician's prescription; models are made and used during thermoforming fabrication. |
| | Hinge is well attached to the trays | - Validation testing showed acceptable performance. |
| | Device's final finish is smooth and free of roughness or burs | - Validation testing showed acceptable performance. |
| Biocompatibility | Materials meet ISO 10993 requirements (trays) | - ISO 10993 testing performed on Thermoforming Sheet Materials (documented in Reference device K200125). - Material is safe and biocompatible for "fabrication of orthodontic and dental appliances."
- Tests include Cytotoxicity and Irritation (implied, as it matches predicate's requirements). |
| | Materials meet ISO 10993 requirements (stainless steel hinge)| - ISO 10993 testing conducted on the stainless steel hinge component:- In vitro Cytotoxicity (Part 5): Met requirements.
- Guinea Pig Maximization Sensitization (Part 10): Met requirements.
- Oral Mucosal Irritation in Hamsters: 14 days (Part 10): Met requirements.
- Test article deemed safe and biocompatible for the intended use. |
| Manufacturing Process | Verification and validation of manufacturing process | - Verification and validation performed by Prismatik Dentalcraft, Inc. - Led to acceptable performance for functional attributes and physical finish. |
| "Clinical" Equivalence | Intended uses are the same as predicate | - "To reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older." - Confirmed as same. |
| | Mechanisms of action are the same | - "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." - Confirmed as same. The minor difference in how the action is achieved (adjustability mechanism) was addressed by V&V testing. |
| | Materials for trays are the same as predicate | - "Heat-sensitive impression dual-layer material." - Confirmed as same. |
| | Manufacturing methods similar | - Confirmed as similar. |
| | Non-sterile | - Device is non-sterile. - Confirmed as same as predicate. |
| | Prescription Use Only; Single patient use, removable, reusable | - Confirmed as same. |
| | Environment of Use: In patient's home or sleep laboratory | - Confirmed as same. |
Study Details Proving Device Meets Acceptance Criteria
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify discrete sample sizes for the functional and manufacturing verification/validation tests. These types of tests typically involve testing a representative number of units from manufacturing runs.
The data provenance is from Prismatik Dentalcraft, Inc. (the manufacturer), indicating these are internal company tests, likely conducted as part of their quality management system for product development and release. The tests are prospective in the sense that they are performed on newly manufactured devices to confirm design specifications and manufacturing quality.
No specific country of origin for the data is mentioned, but the manufacturer is based in Irvine, CA (USA), implying the testing was conducted under US regulatory considerations.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This document details engineering and biocompatibility testing, not clinical studies requiring expert ground truth in the diagnostic sense. Therefore, experts in this context would be test engineers, quality control personnel, and lab technicians. Their qualifications are not specified but would be implicit in their roles within the manufacturing and testing environment (e.g., trained in verification/validation, ISO standards, good laboratory practices).
4. Adjudication Method for the Test Set:
Not applicable in the sense of clinical image review or diagnostic agreement. Adjudication would be based on objective criteria defined in the test protocols (e.g., measurement within tolerance, pass/fail result for biocompatibility tests). Deviations would be addressed through standard quality control and engineering procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No MRMC comparative effectiveness study was described or required. This is a 510(k) submission for a physical medical device, not an AI/software device that would typically involve human reader performance studies. The substantial equivalence relies on the device's design, materials, and mechanism of action being sufficiently similar to a legally marketed predicate, backed by engineering and biocompatibility testing. The predicate device's clinical effectiveness is already established.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This isn't an algorithm or AI device. The testing described is for the physical device itself.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by engineering specifications, material standards (ISO 10993), and functional design requirements. For example, the ground truth for "mandibular advancement function correct" is that the device can reliably achieve the specified 0.25 mm increments up to 10 mm. For biocompatibility, the ground truth is "met requirements of each test" according to ISO 10993.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning product that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As above, no training set is relevant for this type of device.
In summary, this 510(k) submission establishes substantial equivalence for a physical medical device based on engineering verification and validation, biocompatibility testing, and comparison of design and intended use to a predicate device, rather than clinical efficacy trials or AI/software performance studies.
§ 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.”