(88 days)
The Acrylic Splint Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea. The Acrylic Splint Herbst Appliance 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 Acrylic Splint Herbst Appliance consists of an upper and lower acrylic splint custom fabricated to the teeth. These full arch splints are connected to each other by the Herbst mechanism which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of motion while the jaws are orientated in the biting relationship dictated by the positioning of the Herbst mechanism as it connects to the respective arch splints.
The functional relationship built into the appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion of the mandible in relation to the maxilla. This forward repositioning, which is temporary while the appliance is being used, increases the pharyngeal space which assists the patient with improved air exchange.
The prescribing dentist determines the exact repositioning of the lower bite via a wax construction bite obtained from the patient in the clinic. The dentist is also able to fine tune the jaw positioning clinically as needed by altering the Herbst mechanism and/or adjusting the acrylic portions of the appliance.
The provided text is a 510(k) summary for the Acrylic Splint Herbst Appliance. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as one might find for a novel or entirely different technology.
Therefore, the document does not contain the information requested in the prompt regarding specific acceptance criteria, a study proving device performance against those criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document primarily states:
- Intended Use: "The Acrylic Splint Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea."
- Substantial Equivalence: Claims substantial equivalence to the Removable Acrylic Herbst by Allesee Orthodontic Appliances (K070327) based on "the same intended use and technological characteristics."
- Risk Mitigation: Describes the design features to address potential risks like oral soreness, TMD concerns, obstruction of oral breathing, and tooth movement, as identified in the Class II Special Controls Guidance Document.
In summary, the provided text does not contain a study demonstrating device performance against specific acceptance criteria. Its purpose is to argue for substantial equivalence based on intended use, technological characteristics, and risk mitigation strategies aligned with existing guidance, rather than presenting a de novo performance study.
§ 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.”