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The Auradorm sleep appliance is a dentist prescribed mandibular repositioning device worn during sleep to reduce the incidence of snoring and reduce the effects of mild to moderate obstructive sleep apnea for patients 18 years or older.

The Auradorm Sleep Appliance is a one piece oral appliance used for reducing snoring and the effects of mild to moderate obstructive sleep apnea. The one piece upper and lower tooth engaging appliance covers the occlusal and buccal aspects of the entire lower arch teeth and the occlusal and buccal aspects of the posterior maxillary teeth to include the maxillary canines. The maxillary central and lateral incisors do not touch the appliance. The device does not rest or impinge on soft tissue. The oral appliance is prescribed by a dentist and custom fit to the patient's mouth in the dental clinic. The oral appliance is made of FDA approved dental acrylic or resin, stainless steel ball clasps and orthodontic stainless steel braid embedded in the acrylic for strengthening purposes. The appliance is designed to limit the amount of material on the lingual aspect of the teeth and still maintain the anti-snoring functionality based on the predicate devices. The appliance has an anterior opening to prevent restriction of mouth breathing and is reinforced with orthodontic stainless steel metal braid embedded in the acrylic. Ball clasps are situated in the appliance to provide upper and lower tooth retention and adjustability for patient comfort.

Here's an analysis of the provided text regarding the Auradorm Sleep Appliance, focusing on acceptance criteria and supporting study details.

Important Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It typically does not contain detailed information about a comprehensive clinical study to prove the device meets specific performance acceptance criteria through quantitative metrics like accuracy, sensitivity, or specificity. Instead, the focus is on showing similarity in intended use, technological characteristics, and safety/efficacy principles to existing, approved devices. Therefore, many of the requested items (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, specific ground truth types with quantitative results) are not present in this type of submission.

Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to predicate devices, rather than meeting specific quantifiable performance metrics from a dedicated clinical trial for a novel device. The criteria are implicitly met by showing similarity in design, materials, and intended use, and by highlighting the device's design features that address potential risks.

• "The Auradorm is substantially equivalent to the predicates because the device has the same intended uses..." |
  | Similar Technological Characteristics to Predicates: | - Overnight use: Yes
• Single patient multi-use: Yes
• Easily removed from mouth: Yes
• Can be adjusted or refit: Yes
• Cleaned and inspected daily: Yes
• Placed in mouth each night: Yes
• Use at home or sleep lab: Yes
• Prevents grinding of teeth: Yes
• Dentist prescribed device: Yes
• Mandibular repositioning: Yes
• Custom fit for each patient: Yes
• Acrylic fits over upper and lower teeth: Yes
• Materials: Non-sterile Dental Acrylic (Methyl methacrylate), Dental Resin, Metal Ball Clasps (Stainless Steel), Orthodontic metal braid (Stainless Steel). Differences in materials (Dental Resin, Orthodontic metal braid) are noted but deemed not to raise new safety/effectiveness questions. |
  | Addressed Safety Concerns (Risks to Health): | - Gingival soreness: "Appliance is custom fit to the patient's natural dentition and does not rest on or touch gingival tissue."
• TMD Concerns: "Prescribing dentist should perform a TMJ examination prior to using the Auradorm... Some patients do report sensations... but these are usually transitory... Dentist can also slightly alter the jaw position... If discomfort persists a new bite registration can be taken..."
• Obstruction of Oral Breathing: "Anterior opening created in the design... increases the airway by limiting the amount of acrylic on the lingual aspect of the teeth."
• Loosening or flaring of teeth: "Fabricated to minimize tooth movement due to occlusal coverage of all teeth except the maxillary central and lateral incisors... reduces local forces and pressure... Dentist is also able to easily control pressure on teeth by adjusting the acrylic."
• Polysomnogram Results (Potential alteration): "patient must receive a complete dental examination, a complete TMJ evaluation, and a complete medical examination which includes a sleep study by a certified sleep physician... Follow-up sleep studies with the patient using the device is highly recommended..."
• Material Composition (Safety): "Fabricated from known dental materials used for decades throughout the industry." (Stainless Steel, Methyl methacrylate). |
  | No New Questions of Safety or Effectiveness Raised by Differences: | - "The minor differences in the Auradorm's technological characteristics do not raise any new questions of safety or effectiveness, thus the Auradorm is substantially equivalent to the referenced predicate devices." |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable / Not Provided: The 510(k) summary does not describe a specific clinical study with a "test set" in the context of device performance metrics (e.g., accuracy, sensitivity) for a diagnostic or therapeutic effect. The demonstration of substantial equivalence relies on comparing the device's characteristics to already legally marketed devices, not on new clinical data proving effectiveness quantitatively in a test cohort.

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 / Not Provided: As no specific clinical test set for performance comparison is described, there's no mention of experts or ground truth establishment in this manner. The "ground truth" for the device's claims is largely based on the established effectiveness and safety profile of the predicate devices and the general understanding of mandibular repositioning for sleep apnea/snoring by the dental/medical community.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable / Not Provided: No adjudication method is mentioned as there is no specific clinical test set or review process involving multiple experts for quantitative performance.

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 oral appliance, not an AI-powered diagnostic or assistance tool for human readers. Therefore, an MRMC study or AI-related effectiveness metrics are irrelevant and not part of the submission.

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

• Not Applicable: This is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this 510(k) submission is primarily derived from:
  • Regulatory Predicate Equivalence: The established safety and effectiveness of the legally marketed predicate devices (Lamberg Sleep Well Device K062333, Snore Guard K103004, Acrylic Herbst Appliance K083209).
  • Commonly Accepted Dental/Medical Principles: The document references "It is commonly accepted in the dental community that anterior positioning of the tongue and mandible increases pharyngeal space that improves air exchange." and "The Auradorm Sleep Appliance is based on the principles of repositioning the mandible to open the airway which is similar to many marketed anti-snoring devices."
  • Material Safety: The use of "FDA approved dental acrylic or resin" and "known dental materials used for decades throughout the industry."

8. The sample size for the training set

• Not Applicable / Not Provided: There is no "training set" in the context of an algorithm or a clinical trial for this type of 510(k) submission. The device design and safety principles are based on existing knowledge and predicate devices.

9. How the ground truth for the training set was established

• Not Applicable / Not Provided: As there is no training set mentioned, this question is not relevant to the information provided.

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