(105 days)
The SomnoGuard® SP Soft is a mandibular advancement device and is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSAS) in adults.
The entire family of SomnoGuard mandibular advancement devices is used for treating snoring and mild to moderate obstructive sleep apnea. The principal effect of all appliances is the advancement of the lower jaw, thereby opening the upper airway and reducing snoring and the breathing arrests due to mild to moderate obstructive sleep apnea.
SomnoGuard can be fitted without the need of taking a patient's dental impressions as a prerequisite to construct the ready-to-use device. SomnoGuard devices are "boil-&-bite" appliances. To prepare fitting of the appliance it is necessary to heat the appliance in hot water that has been boiled for approximately 3:30 seconds. Thereafter, when the device is removed from the hot water and has cooled down for about 10 seconds, a physician or his or her trained staff inserts the device into the mouth of the patient, thereby first the lower jaw into the lower arch, then the upper jaw into the upper channel of the device. The patient then puts forward his or her lower jaw commonly at normal bite conditions to approximately half the maximum extension possible, with the plastic still warm and mouldable, and then firmly bites the plastic. When doing this, patient sucks in while closing the mouth and pressing the tongue against the inner surface of the front teeth. In parallel, doctor presses his or her fingers on the outer walls of the mouthpiece to make sure that the appliance is properly moulded. The process is completed by fixing the bite impression by rinsing the device in cold water.
SomnoGuard® AP (AP = Adjustable Positioner) as well as SomnoGuard® SP Soft (SP = Sagittal Positioner) are two-part infinitely adjustable appliances enabling a protrusion of up to 10 mm, allowing lateral lower jaw movement and breathing through the mouth whenever needed. The devices consist of two independent trays each with a thermoplastic body, and both parts linked to each other by a coupling protrusion mechanism. The outer tray shells consist of solid, clear and transparent medical grade polycarbonate. The inner lining which accommodates the teeth impressions is made of a thermoplastic copolymer which is similar to that used with the previously FDA cleared SomnoGuard® one-part appliances. After the oral appliance is heated in a hot water bath its thermoplastic body moulds easily to the teeth and jaws allowing any medical doctor to very easily fit the device chair side.
The SomnoGuard® SP Soft two connectors, made out of Polyoxymethylene (POM), connect the lower and the upper part of the appliance. Each device comes with 6 connectors of different length, enabling individual protrusion of up to 10 mm.
The provided text focuses on the 510(k) premarket notification for the SomnoGuard® SP Soft device, asserting its substantial equivalence to predicate devices based on existing scientific literature and general knowledge of mandibular advancement devices (MADs). This type of submission relies on established effectiveness of the device type rather than specific new clinical trials directly on the SomnoGuard® SP Soft to demonstrate performance against acceptance criteria.
Therefore, many of the requested elements pertaining to a specific study demonstrating device performance against acceptance criteria are not present in the provided text. The submission explicitly states: "Substantial equivalence is based on non-clinical data as it relates to the historical significance of oral devices that reposition the jaw and reduce or manage snoring." and references general acceptance of MADs for snoring and mild to moderate OSAS.
Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety (Material biocompatibility, mechanical integrity, etc.) | Not explicitly stated with specific metrics or criteria for the SomnoGuard® SP Soft itself. The submission implies safety by using identical materials for the thermoflexible impression material and hard shell trays as the predicate device (SomnoGuard® AP) and referencing general "safety" of oral appliance therapy. |
| Effectiveness for Snoring Reduction | Not explicitly stated with specific metrics or criteria for the SomnoGuard® SP Soft itself. The submission cites a Pancer et al. (1998) article reporting 95% success in reducing/controlling snoring for MADs in general, and the American Academy of Sleep Medicine (1995) supporting oral appliance effectiveness for snoring. The device is claimed to perform "as well as the predicate devices," which are also intended for snoring reduction. |
| Effectiveness for Mild to Moderate Obstructive Sleep Apnea (OSAS) Reduction | Not explicitly stated with specific metrics or criteria for the SomnoGuard® SP Soft itself. The submission cites the American Academy of Sleep Medicine (1995) supporting oral appliance effectiveness for managing snoring and also mentions "reducing breathing arrests due to mild to moderate obstructive sleep apnea." The statement that it performs "as well as predicate devices" extends to this indication. The text also states that "Own clinical data from clinical studies in Germany, the U.S. and Belgium, as well a numerous number of articles referring to other MADs repeatedly looked at oral appliances and their use for the treatment of snoring confirm that oral appliance therapy is an effective means by which snoring can be managed and breathing arrests due to mild to moderate obstructive sleep apnea can be reduced." |
| Fit and Adjustability | The device is designed as a "boil-&-bite" appliance that "moulds easily to the teeth and jaws." It is "infinitely adjustable appliances enabling a protrusion of up to 10 mm," and comes with 6 connectors of different lengths for individual protrusion. This relates to the usability and intended mechanism of action. No specific quantifiable acceptance criteria are provided. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. No specific test set for the SomnoGuard® SP Soft performance is detailed, as the submission relies on substantial equivalence to predicate devices and general scientific literature on MADs.
- Data Provenance: The text mentions "Own clinical data from clinical studies in Germany, the U.S. and Belgium" and "numerous number of articles referring to other MADs." This suggests a general pool of data, not a specific test set for the current device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No specific test set for the SomnoGuard® SP Soft is described. The "ground truth" for the efficacy of MADs in general would be derived from the vast body of published medical literature and clinical consensus, involving numerous sleep specialists, dentists, and researchers over many years.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No specific test set or adjudication process for this device's performance is described.
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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 oral appliance, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical oral appliance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the claims of effectiveness for MADs in general is based on a combination of:
- Expert Consensus: As cited by the American Academy of Sleep Medicine Guidelines.
- Outcomes Data: From numerous clinical studies reported in scientific literature, demonstrating reduction in snoring and improvement in AHI (Apnea-Hypopnea Index) for patients using MADs.
- Physiological Basis: The demonstrated imaging improvements of the airway with oral appliances.
- The "ground truth" for the claims of effectiveness for MADs in general is based on a combination of:
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The sample size for the training set:
- Not applicable. As this is not an AI/machine learning device, there is no "training set."
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How the ground truth for the training set was established:
- Not applicable.
§ 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.”