(222 days)
Snorer's Friend is an intra-oral mandibular advancement device used during sleep to reduce snoring and treat mild to moderate Obstructive Sleep Apnea (OSA) in adults.
The 'Snorer's Friend' is an intra-oral mandibular advancement device used during sleep to reduce snoring by advancing the lower jaw and thereby minimizing air obstruction and turbulence. It advances the lower jaw and tongue forward so the airway will remain open during sleep. The device is fitted to the patient by, or under the direction of, physicians (e.g., ENT doctors, sleep lab doctors or dentists) or their trained medical staff by immersing it in boiling water for approximately 17 seconds. Once removed from the hot water, it is very gently rotated to allow excess water to run off. Snorer's Friend is custom fitted to the upper and lower teeth, in a similar fashion to an athletic mouth guard. When boiled, the material softens which allows the device to be molded to the shape of the patient's teeth. To prepare for the fitting, the spatula provided is used to place the device in boiled water for 17 seconds. Holding the mouth of the patient open and the lower jaw forward, the physician or their trained medical staff places the device in the mouth and the patient bites down firmly. The device is then placed in cold water. The Snorer's Friend is simple to fit and does not require impressions or lab-fabrication. As such, it is a more economical and timesaving alternative to more costly labfabricated mandibular advancement devices. Snorer's Friend intra-oral mandibular advancement devices are only to be fitted/re-fitted by, or under the direction of, physicians (e.g., ENT doctors, sleep lab doctors or dentists) or their trained medical staff. The patient should undergo a comprehensive oral health assessment by a dentist before the device is fitted to the patient. The maximum mandibular advancement to be performed with this device is 5 mm.
This document describes the Snorer's Friend, an intra-oral mandibular advancement device, and its substantial equivalence to a predicate device. It does not contain information about an AI-based device, nor details of acceptance criteria or a study proving that an "AI-device" meets those criteria. Therefore, most of the requested information cannot be extracted.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (SomnoGuard) for a traditional medical device (Snorer's Friend), not an AI-enabled one. As such, information regarding acceptance criteria, studies for AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable or present in this document.
However, some relevant information regarding the device and its comparison to the predicate is available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in the context of measurable performance metrics typically associated with AI devices (e.g., sensitivity, specificity, AUC). Instead, substantial equivalence is based on similar intended use, design, technology, materials, and performance characteristics compared to a predicate device.
The table below summarizes the comparison presented between the Snorer's Friend and its predicate, which implicitly serves as the "performance" benchmark for establishing equivalence.
| Feature / Characteristic | Predicate (SomnoGuard) | Snorer's Friend |
|---|---|---|
| Indications for Use | The SomnoGuard series of mandibular advancement devices is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. | Snorer's Friend is an intra-oral mandibular advancement device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea (OSA) in adults. |
| Design | Prefabricated “boil & bite” one-piece mandibular advancement device designed to be fitted to upper and lower teeth. | Prefabricated “boil & bite” one-piece mandibular advancement device designed to be fitted to upper and lower teeth. |
| Components | Monobloc mouthpiece. Filler material. Storage case. Wooden spatula. User instructions. | 2 x mandibular advancement devices. Storage case. 2x Wooden spatulas. User instructions. |
| Environments of use | Home, Sleep laboratories | Home, Sleep laboratories |
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older |
| Contraindications | Central sleep apnea, Mandibular joint disorder, (Strong) gag reflex, larger gaps between the teeth, unstable dental crowns, decay, periodontitis – Limited mandibular advancement. Patients with sleep apnea should be able to extend their lower jaw forward at least 7mm. Restricted breathing through the nasal passages | People under the age of 18 years old, those whom have been diagnosed with central sleep apnea, have a severe respiratory disorder/s, have loose teeth or advanced periodontal disease. Have loose dental work, dentures, unstable dental crowns, or other oral conditions which would be adversely affected by wearing dental appliances |
| Prescription | Prescription use | Prescription use |
| Patient use | Single patient, multiple use. | Single patient, multiple use. |
| Duration of use | No limitation | No limitation |
| Principle of operation | Repositions the lower jaw and thereby holds the base of the tongue forward. The airway remains open, by increasing the clearance between the back of the tongue and the back of the throat. | Repositions the lower jaw and thereby holds the base of the tongue forward. The airway remains open, by increasing the clearance between the back of the tongue and the back of the throat. |
| Fixed tray sizes | Yes | Yes |
| Fitting procedure | Custom Fitting (boil & bite) | Custom Fitting (boil & bite) |
| Movement | Lateral and vertical | Lateral and vertical |
| Cleaning procedure | Brushing with a soft toothbrush and 2 to 3 drops of a washing-up liquid or a liquid denture cleaner | Brushing with a normal toothbrush and toothpaste, as often as required. |
| Sterile | No | No |
| Material | Thermoplastic copolymers | Thermoplastic copolymers |
| Biocompatibility | Biocompatible | Biocompatible |
| Expected Lifetime | Up to two years | 4-24 months |
2. Sample size used for the test set and the data provenance:
- Not applicable as this is not an AI-device study. The equivalence is based on design and material comparisons, not a clinical "test set" in the context of an AI algorithm.
- The document states: "Snorer's Friend has similar design, technology, and indications for use as the predicate SomnoGuard and therefore Section 8 - Clinical Data is not applicable."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI-device study requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- No, this was not done as it is not an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this was not done as it is not an AI-enabled device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For this type of device, "ground truth" would relate to its physical properties, biocompatibility, and user-fitting success, which are addressed through design verification and validation activities and comparison to the predicate.
8. The sample size for the training set:
- Not applicable as this is not an AI-device study.
9. How the ground truth for the training set was established:
- Not applicable as this is not an AI-device 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.”