(260 days)
The EndSnor™ appliance, a dentist prescribed mandibular repositioning (MRP) device, is worn during sleep and is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea. Before a dentist prescribes an EndSnor" appliance for treatment, it is recommended that the patient receive a medical examination including a sleep study diagnosis, and a dental examination including cephalometric and tomography analysis to determine the need for an EndSnor™ appliance.
The EndSnor™ device is a dentist prescribed one-piece anti-snoring/sleep apnea appliance, custom-fit to patients' teeth by a professional dentist. It consists of an acrylic upper and lower posterior bite registration with an acrylic overlay of the posterior teeth, finished to the buccal/lingual height of contour for retention. If needed, the dentist may request stainless steel ball clasps, commonly used in the fabrication of orthodontic appliances, be added for more retention. Four expansion screws, commonly used in the fabrication of orthodontic appliances, are set in the acrylic to allow for mandibular readjustment. Mandibular adjustments are made by turning each screw equally. A labial supporting bar, commonly used in the fabrication of orthodontic appliances, is used to bridge the anterior gap in order to allow for less obstruction of the airway, and to remove the occurrence of loosening or harming of lower anterior teeth.
The provided text is a 510(k) summary for the EndSnor™ device, which is an anti-snoring/sleep apnea device. It establishes substantial equivalence to a predicate device, the Adjustable PM Positioner, rather than presenting a study proving the device meets specific acceptance criteria in the context of a clinical trial.
Therefore, many of the requested categories for acceptance criteria and study details are not directly addressed in this type of regulatory submission. A 510(k) generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and intended use, rather than through independent clinical studies with predefined acceptance criteria.
However, I can extract the relevant information from the document to address the aspects that are covered:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present quantitative acceptance criteria or specific performance metrics from a study. Instead, it demonstrates "substantial equivalence" to a predicate device by comparing attributes. The "performance" is implicitly deemed equivalent to the predicate device.
| Attribute to Demonstrate Equivalence | EndSnor™ Performance/Characteristic | Acceptance Criteria (Implicit: Equivalent to Predicate) |
|---|---|---|
| Intended Use | Reduce snoring and mild to moderate obstructive sleep apnea in persons 18 or older. | Equivalent to Adjustable PM Positioner's intended use. |
| Function | Mandibular Repositioning Device (MRP) | Equivalent to Adjustable PM Positioner's function. |
| Materials | Cold cure splint acrylic; dental expansion screws; non-sterile; optional stainless steel ball clasps; dental lingual bar. | Materials deemed safe and effective as per predicate and common orthodontic use. |
| Design | Custom fit; mandible adjustable with 4 buccal expansion screws; permits breathing through mouth; acrylic fits over upper/lower posterior teeth; labial supporting bar for anterior gap. | Differences from predicate do not raise new safety concerns. Overall design considered safe and effective for intended use. |
| Safety and Efficacy | Similar design and function to predicate; differences do not raise new safety risks. | No new safety concerns or risks compared to predicate. Literature supports the historical significance of such devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) submission does not describe a clinical trial with a test set of data. It relies on a comparison to a predicate device and existing literature.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This document does not describe a study involving human experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication 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 device is a physical appliance, not an AI or diagnostic tool, and no MRMC study or AI assistance is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical appliance and operates with a human user (patient) and a prescribing dentist. No algorithm-only performance is relevant.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device, the Adjustable PM Positioner (K922203), cleared on February 8, 1996, and the general clinical understanding of mandibular repositioning devices for snoring and sleep apnea. The submission asserts that the EndSnor™ device is substantially equivalent to this predicate.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set in this context. The basis for evaluating the EndSnor™ is its comparison to a legally marketed predicate 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.”