(122 days)
The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction in mild to moderate obstructive sleep apnea (OSA) and/or snoring.
The SleepRight Snore Aid is intended for use on adults 18 years of age or older as an aid for the reduction of snoring.
The SleepRight Snore Aid is a customizable adjustable, in 1mm increments up to 6mm total, intraoral mandibular advancement device (MAD). An adjustable stop moves the lower tray, which moves the mandible, to the desired user setting of a position that increases (opens) the pharyngeal space (airway), which aids in minimizing air obstruction and aids in the reduction of snoring during sleep.
The SleepRight Snore Aid consists of two independent, customizable moldable, via hot (not boiling) water and bite method, removable, thermoplastic resin injection molded trays, fitted into the user's mouth, that fit separately over the upper (maxillary) and lower (mandibular) dental arches. The upper tray is provided with an adjustable advancement stop mechanism, one on each side of the rear of the upper tray, that provides the incremental 1mm up to 6mm total adjustment. The lower tray is provided with a fin, one on each side of the tray. As the adjustable advancement stop mechanism on each side of the upper tray is incrementally adjusted, the adjustable advancement stop mechanism on each side of the upper tray engages the fin, in a mating position on each side of the lower tray, stabilizing the mandible in a neutral posture or advances the mandible forward until the desired position that opens the airway and aids in a reduction of snoring during sleep is obtained by the user. Because the mandible is attached to the Oropharynx airway tissues (throat), and its posterior movement collapses the airway, stabilizing the mandible in a neutral or advanced forward position opens the airway for improved breathing. Having two independent dental arch trays allows for freedom of movement of the jaw musculature resulting in more user comfort, compliance and efficacy. Necessary Inspiratory and expiratory rapid expulsion of air is also improved.
Based on the FDA 510(k) Clearance Letter for the SleepRight Snore Aid (K250122), here's an analysis of the acceptance criteria and the study proving the device meets them:
Overall Conclusion: The provided text does not describe a study involving device performance, efficacy, or AI assistance. Instead, the clearance for the SleepRight Snore Aid is based on demonstrating substantial equivalence to previously cleared predicate and reference devices. This means the manufacturer did not conduct new clinical efficacy studies to prove the device meets performance criteria, but rather demonstrated that its design, materials, and intended use are sufficiently similar to devices already recognized as safe and effective.
Therefore, many of the requested criteria regarding performance studies, sample sizes, expert involvement, and ground truth establishment are not applicable in this specific context, as these types of studies were not performed for this 510(k) submission.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present specific quantitative performance acceptance criteria (e.g., a certain percentage reduction in AHI score or snore events) or measured device performance data. The "acceptance criteria" for this 510(k) appear to be based on demonstrating equivalence to predicate devices, particularly in terms of design, materials, manufacturing, intended use, labeling, and a general understanding of safety and efficacy derived from the predicates.
| Acceptance Criteria Category | Specific Criteria (Implicit via Equivalence) | Reported Device Performance (as demonstrated for substantial equivalence) |
|---|---|---|
| Material Biocompatibility | Meet ISO 10993 standards for cytotoxicity, sensitization, irritation. | Demonstrated equivalence of materials and processes to previously tested and FDA-cleared devices (SleepRight Pro Rx Dental Guard, SleepRight Advance dental guard, predicate and reference devices). Biocompatibility tests (ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitization, ISO 10993-23 Irritation) previously conducted on the same materials for predicate devices passed. Justification provided for not repeating subacute/subchronic toxicity or genotoxicity testing based on ISO 10993-1. |
| Physical Properties | Meet or exceed benchmark acceptance criteria for intraoral use per applicable ASTM standards (e.g., Flexural Strength, Tensile Strength, Compressive Strength, Surface Hardness, Water Sorption, Water Solubility). | Assessed using manufacturer-supplied technical data sheets for each component material. Tests included ASTM D790, D638, D695, D2240, D570, D896. All materials met or exceeded benchmark acceptance criteria for intraoral use. |
| Device Design & Function | Mandibular Advancement Device (MAD) providing incrementally adjustable advancement to the mandible which increases (opens) pharyngeal space (airway) to aid in the reduction of snoring. | SleepRight Snore Aid is a customizable adjustable (1mm increments up to 6mm) MAD. It consists of two independent, customizable moldable trays. The adjustable advancement stop engages a fin on the lower tray, stabilizing/advancing the mandible. This is functionally equivalent to the predicate/reference devices. |
| Intended Use | Reduction of snoring (OTC); Reduction in mild to moderate OSA and/or snoring (Rx). | Device indications for use match those of the predicate devices based on the demonstrated equivalence of technological characteristics and function. |
| Safety | Address identified risks (gingival/dental soreness, TMJ, oral breathing obstruction, tooth movement) through material composition, testing, and labeling. | Risks similar to predicates are mitigated through material biocompatibility (as above) and labeling (labeling instructions, contraindications, warnings, precautions are per guidance document, same as predicates). |
| Manufacturing | Injection molded. Ensure consistency and quality. | Device is injection molded, same as predicate and reference devices. |
| Fitting Method | Moldable to dental arches. | Molded via hot (not boiling) water and bite method. This is a difference from predicates (boil and bite) but justified as an improvement (150°F water vs. 212°F boiling water) rather than a performance criterion. |
The Study that Proves the Device Meets the Acceptance Criteria
The study described is primarily a non-clinical bench testing and material characterization study in conjunction with a comparative analysis for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical performance study. For non-clinical testing, it would refer to material samples.
- Data Provenance:
- Material Biocompatibility: Data derived from previous testing on the same materials used in other Splintek products (SleepRight Pro Rx, SleepRight Advance Dental Mouthguard) and predicate/reference devices. This suggests a mix of historical data and potentially some internal material identification (Fourier Transform Infrared Spectroscopy).
- Physical Properties: Data primarily from manufacturer-supplied technical data sheets (TDS) for the raw materials. This data is likely from materials suppliers rather than specific testing of final device components by Splintek for this submission, although the phrasing "These tests were conducted by the material manufacturers" supports this. The provenance would be the material manufacturers' laboratories.
- Retrospective/Prospective: The use of existing data (prior test results, TDS) suggests a retrospective approach to assembling the non-clinical evidence. No prospective clinical data was generated for this 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This was not a human-in-the-loop or clinical performance study requiring expert consensus for ground truth. The "ground truth" for material properties is established by standardized test methods (ISO, ASTM) and material specifications from manufacturers.
4. Adjudication Method for the Test Set
- Not applicable. No expert adjudication was described or required for the substantial equivalence demonstration using material and physical property data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not conducted as the SleepRight Snore Aid is substantially equivalent to the predicate and reference devices in relation to design, materials, manufacturing, intended use, labeling and function."
- Effect Size: Not applicable as no such study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical intraoral appliance, not a software algorithm.
7. The Type of Ground Truth Used
- For Biocompatibility: The "ground truth" was whether the materials passed the specified ISO 10993 standards (e.g., no cytotoxicity, no sensitization, no irritation). This is a laboratory-based, in vitro and in vivo (for sensitization/irritation) standardized testing ground truth.
- For Physical Properties: The "ground truth" was whether the material properties (e.g., flexural strength, hardness) met or exceeded the established benchmark acceptance criteria for intraoral use, as measured by ASTM standards. This is a laboratory-based, standardized physical property testing ground truth.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/machine learning device requiring training sets.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is not an AI/machine learning 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.”