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510(k) Data Aggregation
(118 days)
Dorsal Appliance
The Dorsal Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
The Dorsal Appliance is comprised of upper and lower customized acrylic splints for the treatment of mild to moderate sleep apnea. The upper splint comprises bilateral turnbuckle adjustment mechanisms. The device aims to improve the patient's air exchange thereby reducing snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible.
This document is a 510(k) premarket notification for the Dorsal Appliance, an intraoral device intended for the reduction of nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The submission argues for substantial equivalence to a predicate device, the Acrylic Herbst Appliance.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the document, there are no explicit "acceptance criteria" defined in terms of specific performance metrics or thresholds for the target device (Dorsal Appliance). Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Acrylic Herbst Appliance) through a comparison of technological characteristics, materials, and intended use. The performance "reported" is primarily a statement that the materials and fabrication processes are identical to the predicate device, implying similar performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: | The Dorsal Appliance has the "same intended use" as the predicate: "The reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA)." |
| Technological Characteristics Equivalence (no new safety/effectiveness questions): | The "fundamental scientific technology... is the same" as the predicate. "Each of the design features is common to the predicate." |
| Material Equivalence: | "The materials and fabrication processes used in the manufacture of the subject device are identical to the materials and fabrication processes used in the manufacture of the predicate device." Materials: medical grade polymethylmethacrylate (acrylic splints) and stainless steel (adjustment screw mechanism). |
| Biocompatibility: | "Because material biocompatibility was accepted for the predicate and because there are no differences in manufacturing which could affect biocompatibility, additional biocompatibility testing was not supplied in support of this clearance." |
| Physical Properties: | "Data regarding performance testing of the device material was provided." "Because the identical material is used for both the subject and predicate devices, these performance results support the finding of substantial equivalence. The results included general properties (water solubility and absorption) and physical properties (tensile and flexural strength, and elastic modulus)." (Specific numerical values for these properties are not provided in the excerpt.) |
| Risk Mitigation: | "A risk analysis was performed... The risks identified in the guidance (e.g., intraoral gingival, palatal, or dental soreness; TMJ Dysfunction Syndrome; obstruction of oral breathing and loosening or flaring of lower anterior teeth or general tooth movement) and those detected by the risk analysis were mitigated though the use of biocompatible materials identical to those used in the predicate and the use of appropriate labeling." |
| Differences addressed: | The only differences noted are the "type of advancement mechanism used" (turnbuckle for the subject device vs. telescopic for the primary predicate) and the "adjustable range" (5mm for the subject device vs. 5.5mm for the primary predicate). These differences are argued not to raise new safety and effectiveness questions, as the turnbuckle mechanism is used in other similar intra-oral devices (reference predicate Dorsal Appliance, K103076) and the adjustable range falls within limits of other similar predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not applicable. The document explicitly states: "Clinical testing of the subject device was not used in support of clearance." This was a substantial equivalence submission based on non-clinical data (material properties, design comparison, risk analysis) relative to a predicate device.
- Data provenance: Not applicable, as there was no clinical test set. The data presented relates to material properties and comparative design analysis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no clinical test set requiring ground truth establishment by experts for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set was used.
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 mechanical intraoral appliance, not an AI-powered diagnostic or assistive technology.
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 an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for a clinical test set. The "ground truth" for the substantial equivalence argument relies on the established safety and effectiveness of the predicate device (Acrylic Herbst Appliance, K113126) and the materials used, as well as regulatory guidance for this device class.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning system that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/machine learning system.
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(345 days)
NDX DORSAL APPLIANCE
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.
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