(345 days)
The ClearDream® is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The ClearDream® is an intraoral device and is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The product is a prescription-only, customized device for use by a single patient; dentist titratable mandibular repositioning device worn during sleep to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. Dental impressions must be used to construct the device. A bite registration reflecting the relationship between the patient's mandible (lower jaw) and maxilla (upper jaw) is taken at the dental office. The product consists of 2 pieces. Both pieces are constructed using polymethyl methacrylate acrylic (PMMA). One piece fits over the maxillary (upper jaw) dental arch and is retained by the maxillary teeth. The maxillary piece has blocks of acrylic located bilaterally on the buccal surfaces. One expansion stainless steel screw is encased in each one of the acrylic blocks. The mandibular (lower jaw) piece is fitted over the mandibular arch and is retained by the lower dental arch. The mandibular piece features bilateral buccally located flanges that engage the upper mechanisms. This engagement repositions the mandible protrusively to decrease air turbulence, increase pharyngeal space, and maintain airway patency. It also permits the patient to open their mouth allowing patient comfort. The ClearDream® appliance keeps the PMMA covering the lingual surfaces of the lower teeth to a minimum. The duration of the interval of wearing the device is 8 hours or less. The PMMA material used is identical to the predicate device, and therefore does not present any possible biocompatibility differences that have been tested on the PMMA. The ClearDream® is accompanied by an adjustment key used by the dentist. The dentist uses the adjustment key to move the bilateral, buccally-located expansion stainless steel screws allowing forward mandibular advancement a maximum from baseline of 6.5 millimeters, thereby improving patency of the airway, decreasing air turbulence, and reducing obstructive apnea occurrences.
The provided document describes the FDA 510(k) clearance for the ClearDream® device, an intraoral device intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The clearance is based on substantial equivalence to a predicate device, the Somnomed MAS RXA (K050592), rather than a standalone study with acceptance criteria.
Therefore, the information you requested about acceptance criteria, study data, sample sizes, expert ground truth, adjudication methods, MRMC studies, and training set details are not applicable to this specific submission. The regulatory approval here relies on demonstrating similarity to an already approved device ("predicate device") rather than proving direct performance against pre-defined acceptance criteria through a de novo study.
However, I can provide the available information regarding the device comparison and non-clinical testing that led to its clearance.
Device Comparison and Non-Clinical Performance
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, there are no explicit "acceptance criteria" for the ClearDream®'s performance that are separately reported with numerical results. Instead, the "performance" is demonstrated by showing that its technical characteristics, intended use, and materials are substantially equivalent to the predicate device.
The following table summarizes the comparison to the predicate device, which serves as the basis for the implicit acceptance that the device performs equivalently.
| Characteristic | ClearDream® | Somnomed MAS RXA (Predicate) | Result (Substantial Equivalence) |
|---|---|---|---|
| Intended Use | |||
| Intraoral device | Yes | Yes | Equivalent |
| Reduce snoring | Yes | Yes | Equivalent |
| Treatment of mild to moderate OSA | Yes | Yes | Equivalent |
| Nighttime use | Yes | Yes | Equivalent |
| Single patient multi-use | Yes | Yes | Equivalent |
| Use at home or sleep laboratories | Yes | Yes | Equivalent |
| Adult population | Yes | Yes | Equivalent |
| Design Attributes | |||
| Customized fit | Yes | Yes | Equivalent |
| Separate upper and lower trays | Yes | Yes | Equivalent |
| Bilateral design engaged w/ upper mechanisms | Yes | Yes | Equivalent |
| Mandibular advancement | Yes | Yes | Equivalent |
| Adjustable/refittable | Yes | Yes | Equivalent |
| Lower jaw adjustment w/ supplied components | Yes | Yes | Equivalent |
| Permits mouth breathing | Yes | Yes | Equivalent |
| Upper and lower trays disengage | Yes | Yes | Equivalent |
| Cleaned/inspected daily by patient | Yes | Yes | Equivalent |
| Stainless steel expansion screws for titration | Yes | Yes | Equivalent |
| Titration by dentist | Yes | Yes | Equivalent |
| Material | |||
| Trays: Polymethyl methacrylate acrylic (PMMA) | Yes | Yes | Equivalent |
| Bilaterally adjustable stainless steel hardware | Yes | Yes | Equivalent |
| Advancement mechanism: surgical grade stainless steel | Yes | Yes | Equivalent |
| Mandibular piece: bilateral buccally located flanges | Yes | Yes | Equivalent |
Note on Mandibular Advancement: The ClearDream® allows for 1 millimeter more mandibular advancement than the predicate device. However, this difference was deemed to be "well within the range of mandibular advancement in other previously cleared FDA intraoral devices" and does not raise new safety concerns, as titration is the responsibility of the dentist.
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. No clinical test set data was provided or required for this 510(k) submission. The clearance was based on substantial equivalence, and for such devices, the FDA Modernization Act of 1997 allows for not requiring clinical studies if the intended use and technology are identical or very similar to a predicate device.
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. No clinical test set requiring expert ground truth was performed for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication was performed for this 510(k) submission.
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 an intraoral appliance, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI-assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an intraoral appliance, not an algorithm. Its performance is tied to its physical design, materials, and how it's used by a patient under a dentist's care.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth data was used for this 510(k) submission. The evaluation was primarily based on non-clinical performance data (material testing, risk analysis) and a comparison of technical characteristics to a predicate device.
8. The sample size for the training set
Not applicable. This device is an intraoral appliance; it does not involve machine learning or an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used.
Summary of Device Approval Basis:
The ClearDream® received 510(k) clearance based on demonstrating substantial equivalence to the Somnomed MAS RXA (K050592) predicate device. This included:
- Identical Indications for Use: Reduction of night time snoring and mild to moderate OSA in adults.
- Similar Technological Characteristics: The design attributes, functionality (e.g., customized fit, separate upper/lower trays, mandibular advancement, adjustability, mouth breathing allowance, daily cleaning), and materials (PMMA and stainless steel components) are considered identical or sufficiently similar to the predicate device.
- Non-Clinical Performance Data: The device conforms to FDA Class II Special Controls Guidance for Intraoral Devices for Snoring/OSA (November 12, 2002). Material composition (PMMA) was tested and found to comply with ISO 7405, ISO 10993 part 5 and part 10 standards, and material characteristics meet ASTM standards. A risk analysis was conducted, addressing risks outlined in the FDA guidance and identifying no additional risks.
- Biocompatibility: The material composition of PMMA was tested and found to comply with ISO 10993 part 5 and part 10, indicating it is biocompatible and identical to the predicate device's materials.
- No Clinical Data Required: In accordance with the "least burdensome provisions" of the FDA Modernization Act, clinical studies were not requested because the device's intended use, design, and technology are identical or very similar to the claimed predicate 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.”