(118 days)
The Dorsal Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
The Dorsal Appliance is comprised of upper and lower customized acrylic splints for the treatment of mild to moderate sleep apnea. The upper splint comprises bilateral turnbuckle adjustment mechanisms. The device aims to improve the patient's air exchange thereby reducing snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible.
This document is a 510(k) premarket notification for the Dorsal Appliance, an intraoral device intended for the reduction of nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The submission argues for substantial equivalence to a predicate device, the Acrylic Herbst Appliance.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the document, there are no explicit "acceptance criteria" defined in terms of specific performance metrics or thresholds for the target device (Dorsal Appliance). Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Acrylic Herbst Appliance) through a comparison of technological characteristics, materials, and intended use. The performance "reported" is primarily a statement that the materials and fabrication processes are identical to the predicate device, implying similar performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: | The Dorsal Appliance has the "same intended use" as the predicate: "The reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA)." |
| Technological Characteristics Equivalence (no new safety/effectiveness questions): | The "fundamental scientific technology... is the same" as the predicate. "Each of the design features is common to the predicate." |
| Material Equivalence: | "The materials and fabrication processes used in the manufacture of the subject device are identical to the materials and fabrication processes used in the manufacture of the predicate device." Materials: medical grade polymethylmethacrylate (acrylic splints) and stainless steel (adjustment screw mechanism). |
| Biocompatibility: | "Because material biocompatibility was accepted for the predicate and because there are no differences in manufacturing which could affect biocompatibility, additional biocompatibility testing was not supplied in support of this clearance." |
| Physical Properties: | "Data regarding performance testing of the device material was provided." "Because the identical material is used for both the subject and predicate devices, these performance results support the finding of substantial equivalence. The results included general properties (water solubility and absorption) and physical properties (tensile and flexural strength, and elastic modulus)." (Specific numerical values for these properties are not provided in the excerpt.) |
| Risk Mitigation: | "A risk analysis was performed... The risks identified in the guidance (e.g., intraoral gingival, palatal, or dental soreness; TMJ Dysfunction Syndrome; obstruction of oral breathing and loosening or flaring of lower anterior teeth or general tooth movement) and those detected by the risk analysis were mitigated though the use of biocompatible materials identical to those used in the predicate and the use of appropriate labeling." |
| Differences addressed: | The only differences noted are the "type of advancement mechanism used" (turnbuckle for the subject device vs. telescopic for the primary predicate) and the "adjustable range" (5mm for the subject device vs. 5.5mm for the primary predicate). These differences are argued not to raise new safety and effectiveness questions, as the turnbuckle mechanism is used in other similar intra-oral devices (reference predicate Dorsal Appliance, K103076) and the adjustable range falls within limits of other similar predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not applicable. The document explicitly states: "Clinical testing of the subject device was not used in support of clearance." This was a substantial equivalence submission based on non-clinical data (material properties, design comparison, risk analysis) relative to a predicate device.
- Data provenance: Not applicable, as there was no clinical test set. The data presented relates to material properties and comparative design analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no clinical test set requiring ground truth establishment by experts for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set was used.
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 device is a mechanical intraoral appliance, not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a clinical test set. The "ground truth" for the substantial equivalence argument relies on the established safety and effectiveness of the predicate device (Acrylic Herbst Appliance, K113126) and the materials used, as well as regulatory guidance for this device class.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning system that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/machine learning system.
§ 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.”