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510(k) Data Aggregation
(125 days)
A customized mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.
The Medley Gold series oral appliance design concept is based upon the use of a standard set of upper and lower trays that have been customized by a dentist that then may have one of three (3) options attached to the trays to act as a Mandibular Repositioning Device (MRD).
The rationale for have a single set of customized trays that may have different MRD methods attached is that some patients have a personal preference and some configurations are more comfortable for them. Therefore rather than having to make another set of custom travs, the dentist may use the same trays and just change the method of MRD, i.e. bands, links, or rods, to the same set of trays.
The principle of advancing a lower tray so that it advances the mandible for the treatment of snoring and / or obstructive sleep apnea is well known and there a number of predicate devices.
The proposed Medley Gold device has three (3) methods of advancing the lower tray based upon the identical designs of 3 already cleared predicate designs.
The provided text describes the Medley Gold series oral appliances, which are intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients. The device comes in three configurations: Band, Link, and Rod, each compared to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The Medley Gold device's acceptance criteria are not explicitly stated as quantitative performance metrics. Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices. The "performance" is implicitly defined by meeting or being similar to the characteristics of these legally marketed predicate devices.
| Feature / Acceptance Criteria (Implicit) | Medley Gold - Band Performance (vs. Frantz EMA K971794) | Medley Gold - Link Performance (vs. ResMed Narval CC K113201) | Medley Gold - Rod Performance (vs. Strong Dental SUAD K023836) |
|---|---|---|---|
| Indications for Use: Reduce/alleviate night-time snoring and mild to moderate OSA in adults 18+. | Substantially equivalent to Frantz EMA (treating snoring and OSA). | Substantially equivalent to ResMed Narval CC (reduce/alleviate snoring and treat OSA). | Substantially equivalent to Strong Dental SUAD (reduce/alleviate snoring and OSA). |
| Technology/Principle of Operation: Mandibular advancement. | Substantially equivalent to Frantz EMA (separate tray design, elastomeric bands for adjustment). Uses identical EMA bands. | Substantially equivalent to ResMed Narval CC (separate tray design, links of different lengths for adjustment). | Substantially equivalent to Strong Dental SUAD (separate tray design, adjustable rods for adjustment). |
| Materials: Standard off-the-shelf dental materials in contact with patient. | Uses Durasoft, Splint Biocryl, Biocryl X glue, supports, nuts, screws, bands. Described as "Similar materials" to predicate. | Uses Durasoft, Splint Biocryl, Biocryl X glue, supports, nuts, screws, links. Described as "Similar materials" to predicate. | Uses Durasoft, Splint Biocryl, Biocryl X glue, supports, nuts, rods, screws. Described as "Similar materials" to predicate. |
| Environment of Use: Home, Dental offices, Sleep laboratories. | Similar to Frantz EMA. | Substantially equivalent to ResMed Narval CC. | Substantially equivalent to Strong Dental SUAD. |
| Patient Population: Adult patients 18 years and older. | Substantially equivalent to Frantz EMA (18 years and older). | Substantially equivalent to ResMed Narval CC (18 years and older). | Substantially equivalent to Strong Dental SUAD (18 years and older). |
| Contraindications: (Central sleep apnea, severe respiratory disorders, loose teeth/advanced periodontal disease, under 18 years). | Identical to Frantz EMA. | Identical to ResMed Narval CC. | Identical to Strong Dental SUAD. |
| Prescription Use: Yes | Yes | Yes | Yes |
| Single patient, multi-use: Yes | Yes | Yes | Yes |
| Limitation of duration of use: No limitation | No limitation | No limitation | No limitation |
| Design (Customized tray): Yes | Yes | Yes | Yes |
| Design (Molded in supports): Yes | Yes (Medley Gold) / No (Frantz EMA) - Not a point of equivalence, but a design difference. | Yes (Medley Gold) / No (ResMed Narval CC) - Not a point of equivalence, but a design difference. | Yes |
| Design (Allows lateral and vertical movement): Yes | Yes | Yes | Yes |
| Protrusion Adjustment Range: | 8 mm in 1 mm increments | 8 mm in 1 mm increments (Medley Gold) / 15 mm in 1 mm increments (ResMed Narval CC) - Difference noted, but still considered substantially equivalent. | 8 mm in 1 mm increments (Medley Gold) / unlimited (Strong Dental SUAD) - Difference noted, but still considered substantially equivalent. |
| Physical Properties of Materials: | Materials for customized tray, bands, links, rods tested to demonstrate performance as intended. Note: Tray materials are standardized dental materials. | Materials for customized tray, bands, links, rods tested to demonstrate performance as intended. Note: Tray materials are standardized dental materials. | Materials for customized tray, bands, links, rods tested to demonstrate performance as intended. Note: Tray materials are standardized dental materials. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" involving human subjects or a particular dataset from patients to demonstrate the device's efficacy or safety. The study relies on non-clinical testing of the device's components and a comparison of its design and features with legally marketed predicate devices to establish substantial equivalence.
Therefore, there is:
- No specific sample size for a test set of human patients.
- No data provenance (e.g., country of origin, retrospective/prospective) for a clinical study because no such study on patients is described.
Instead, the "test set" is the Medley Gold device itself and its components, which underwent "specific tests to validate these components and the method of attachment to the trays" (page 7).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the clearance is based on non-clinical testing and substantial equivalence to predicate devices, not on a human-read clinical study requiring expert ground truth establishment for patient data.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as #3.
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
There was no MRMC comparative effectiveness study and no mention of AI. The Medley Gold device is a physical intraoral appliance, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical intraoral appliance, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this submission is the established safety and effectiveness profile of the predicate devices. The Medley Gold device is considered "substantially equivalent" if it shares similar technological characteristics, indications for use, and performs as safely and effectively as the predicate without raising new safety or performance concerns.
For the non-clinical testing of components, the "ground truth" would be established engineering specifications and material properties, which were tested against.
8. The Sample Size for the Training Set
There is no training set in the context of machine learning or AI models, as this device is a physical medical device.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reasons as #8.
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