(204 days)
The Crane Acrylic Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.
The Crane Acrylic Herbst Appliance is comprised of upper and lower patient-specific acrylic splints connected bilaterally via a telescoping Herbst mechanism that orients the jaw in a predetermined relationship. The Herbst mechanism allows the patient vertical and lateral range of movement while the jaws are oriented in the biting relationship determined by the positioning of the mechanism as it connects to the respective arch splint. The Appliance positions the lower jaw forward and open vertically from its normal location which causes a protrusion in the mandible in relation to the maxilla. The appliance aims through this repositioning (which is temporary while the appliance is being used) to increase air exchange, and to reduce snoring and apnea by increasing pharyngeal space.
The prescribing dentist determines the repositioning of the mandible through a patient-specific protrusive bite registration taken by the dentist is also able to adjust the mandible's position by altering the Herbst mechanism, and/or adjusting the acrylic portion of the device. The Acrylic Splint Herbst Appliance is removable by the patient, and is worn while sleeping to support the mandible in a forward position determined by the prescribing dentist.
This document is a 510(k) premarket notification for the Crane Acrylic Herbst Appliance, an intraoral device intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea. The submission claims substantial equivalence to a predicate device, the Respire Medical LLC - Respire Pink Series (K131138), based on similar intended use and technological characteristics.
Here’s a breakdown of the information requested, based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report performance metrics (e.g., specific reductions in snoring or AHI). Instead, it focuses on demonstrating substantial equivalence to a predicate device, arguing that the new device has the same intended use and technological characteristics and does not raise new safety or effectiveness concerns.
| Feature | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Crane Acrylic Herbst Appliance) |
|---|---|---|
| Intended Use | To reduce or alleviate nighttime snoring and mild to moderate OSA | To reduce or alleviate nighttime snoring and mild to moderate OSA |
| Target Population | Adults age 18 and older | Adults age 18 and older |
| Prescription Usage | Prescription Only | Prescription Only |
| Basic Design | Upper and lower trays connected bilaterally via Telescopic Herbst Mechanisms | Upper and lower trays connected bilaterally via Telescopic Herbst Mechanisms |
| Device Functionality | Increase patient's pharyngeal space to improve air exchange by repositioning the mandible thus reducing snoring and mild to moderate OSA | Increase patient's pharyngeal space to improve air exchange by repositioning the mandible thus reducing snoring and mild to moderate OSA |
| Mandibular Advancement Range | Up to 8mm | Up to 8mm |
| Device Components | Medical grade acrylic splints and stainless steel telescopic Herbst mechanisms | Medical grade acrylic splints and stainless steel telescopic Herbst mechanisms |
| Adjustability | By prescribing dentist or physician | By prescribing dentist or physician |
| Method of Manufacture | Patient-specific Customization | Patient-specific Customization |
| Sterility | Non-sterile | Non-sterile |
| Material Composition (Acrylic) | Medial Grade Acrylic-Polymethyl methacrylate Acrylic Splints | Medial Grade Acrylic-Polymethyl methacrylate Acrylic Splints |
| Material Composition (Metal) | Stainless Steel | Stainless Steel |
| Risks Addressed | Intraoral gingival, palatal or dental soreness; Temporomandibular Joint (TMJ) Dysfunction Syndrome; Obstruction of Oral Breathing; Loosening or Flaring of Lower Anterior Teeth or General Tooth Movement | Design addresses these risks, consistent with the predicate device and guidance documents (e.g., distributes force, allows adjustment, full arch coverage). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not describe a specific clinical study or test set with a listed sample size, data provenance, or study design (retrospective/prospective). This 510(k) submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data from a dedicated study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. As no specific clinical test set is described, there's no mention of experts establishing ground truth. The submission's argument is theoretical equivalence based on design and materials, not empirical clinical performance data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set 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. The device is a physical intraoral appliance, not an AI software or a device that requires "readers" for interpretation. Therefore, a MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical appliance and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical study for the new device is presented that would require establishing ground truth from patient data. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device (Respire Medical LLC - Respire Pink Series, K131138), to which the Crane Acrylic Herbst Appliance is deemed substantially equivalent.
8. The sample size for the training set
Not applicable. No clinical study with a training set is described for this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. No clinical study with a training set is described for this 510(k) submission.
§ 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.”