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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

Study Details

1. 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.

2. 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.

3. 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.

4. 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.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This device is a mechanical oral appliance.

6. 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.

7. The sample size for the training set:

   • Not applicable. As this is not an AI/machine learning device, there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable.

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The SomnoGuard Series of mandibular advancement devices (SomnoGuard,2.0,AP and AP Pro) is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in adults.

The whole family of SomnoGuard mandibular advancement devices is used for treating snoring and obstructive sleep apnea. The main 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 obstructive sleep apnea.

SomnoGuard and its minor modification SomnoGuard 2.0 are one-part appliances manufactured from thermoflexible copolymeric material. SomnoGuard can be fitted without the need of taking a patient's dental impressions as a prerequisite to construct the ready-to-use device. To prepare fitting of the appliance it is necessary to heat the appliance in hot water that has been boiled for around 30 seconds. Thereafter, when the device was 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 moldable, 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 molded. After fixing the bite impression by cold water the fitting is finished. To raise the molar bite when necessary (e.g. in case of a "deep-bite") the SomnoGuard pack contains a filler strip made of the same copolymeric material as the appliance itself. To raise the bite the strip is heated in hot water and then sticked in parts into the channel of the appliance.

SomnoGuard 2.0 differs from SomnoGuard by a slightly thicker molar biting zone (i.e. 1.5 mm on each site of the biting plate) and an increase of the molar side walls of 1.0 mm. As opposed to the SomnoGuard time consuming use of the filler strip can thus be avoided with the SomnoGuard 2.0 in patients with a "deep bite".

Both SomnoGuard and - 2.0 contain a hole in the front area, large enough for emergency breathing. Both one-part appliances are primarily considered by sleep specialists and dentists for short-term use up to about one year or as a first-line screening devices to find out whether patients suffering from snoring and / or obstructive sleep apnea (OSAS) respond to oral appliance therapy at all what can't be predicted for any appliance available in the marketplace prior to its usage. Thus in case of no therapeutic effect larger investments for the much more expensive custom dental lab made appliances can be avoided.

The SomnoGuard product family comprises another "boil-&-bite" member i.e., SomnoGuard AP (AP = Adjustable Positioner), a two-part infinitely adjustable (titratable) appliance enabling a protrusion of up to 12 mm, allowing lateral lower jaw movement and breathing through the mouth whenever needed. The device consists of two independent trays with each 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 as it is similarly used with the 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 fit very easily the device chair side.

An adjusting screw made of stainless steel allows the anterior adjustment of the lower tray against the upper tray between 0 and about 12 mm or even more depending on the length of the screw used. The adjustment is only possible extra-orally and when the upper and lower trays are disassembling both trays is also necessary for cleaning.

By using the scale on both sides of the thread you can exactly control the adjustment with an accuracy of about 0.5 mm. Upper and lower trays can be moved laterally.

The highly cost-effective device is considered for medium term use up to two years

All "boil-&-bite" appliances are simple to fit by dentists and other medical specialists, taking about 10 minutes and not requiring any special tools. Since with not any existing oral appliance available in the marketplace treatment outcome can be predicted for sure as already mentioned earlier, it always makes sense from a cost and economical point of view to start treatment at first with cheaper boil & bite devices before doing a larger investment for the fabrication of custom made dental appliances such as the SomnoGuard AP Pro which will be described thereafter.

The currently last family member is the SomnoGuard AP Pro, an always dental lab made two-part titratable mandibular adjustable positioner with its development closely related and derived from the preceeding development of the AP appliance. The SomnoGuard® AP Pro can easilty be constructed from comment acrylic/elastomeric thermoform dental materials in any dental lab after taking impressions of the lower and upper jaws and producing plaster models. The components used to connect the upper and lower travs of the dental appliance and enable the infinite advancement of the lower jaw are made from stainless steel. The component's technology is based on the preceding development of the SomnoGuard® AP. The components are very durable, more or less indestructible, inexpensive and can most often be reused when the oral appliance has to be remade for some reason. The cost-effectiveness of the SomnoGuard AP Pro and the fact that the device can easily be constructed by any dental lab using standard lab equipment are considered as key benefits compared to the more expensive competitive dental appliances.

All stainless steel components of the two-part appliances correspond to the material no.1.4301 (AISI-no. 304) resp. to DIN EN 10088-1. The chemical composition is commonly as follows:

C < 0,07 weight%, Cr 17,0 - 19,5 w%, Ni 8,0 - 10,5 w% und N < 0,11 w%, Si < 1,0 w%, Mn < 2,0 w% .

The provided document is a 510(k) summary for the SomnoGuard Series of mandibular advancement devices. It contains general information about the device, its intended use, and technological characteristics. However, it does not include any study data, acceptance criteria, or performance metrics. The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices for regulatory clearance.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically does not contain detailed study results or acceptance criteria in the format you've requested for device performance.

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