(34 days)
The Doctor's® NightGuard™ Advanced Comfort™ is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
The Doctor's® NightGuard™ Advanced Comfort™ is composed of a soft, formable clear upper material, made of ELVAX® resin (a copolymer of ethylene and viny) acetate) and ELVALOY® (a copolymer of ethylene and methyl acrylate containing 9% methyl acrylate). When heated and then briefly cooled, the upper material can be molded to fit the user's upper teeth. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing. The shock absorbing polymer material cushions the teeth on all sides.
The provided text is a 510(k) summary for a medical device (The Doctor's® NightGuard™ Advanced Comfort™) and explicitly states that "No performance data is required in support of this Special 510(k) notice." This means that no specific study, acceptance criteria, or performance metrics were submitted or evaluated for this particular device in this submission. The device's clearance was based on substantial equivalence to predicate devices, not on new performance data demonstrating its effectiveness.
Therefore, I cannot provide the requested information. If this were a device requiring performance data, the following would be applicable:
Hypothetical Example (if performance data were required):
If this were a device that required performance data, the acceptance criteria and study details would typically be presented as follows. This is a template of what one might expect if a study had been performed and reported.
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., for reduction in bruxism episodes, bite-force distribution, material durability) | Reported Device Performance | Meets Criteria? |
|---|---|---|
| [Example criterion: Reduce average daily bruxism episodes by 50% compared to baseline] | [Example performance: Average daily bruxism episodes reduced by 65%] | Yes |
| [Example criterion: Maintain structural integrity for 6 months of typical use] | [Example performance: No structural degradation observed in 95% of devices after 6 months] | Yes |
| [Example criterion: Achieve a comfort rating of ≥ 4 out of 5 on a subjective user scale] | [Example performance: Average comfort rating of 4.2] | Yes |
| [Add more criteria as relevant to the device's function] | [Add corresponding performance data] | [Yes/No] |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: [e.g., 100 participants, 500 images]
- Data Provenance: [e.g., Retrospectively collected data from a dental clinic in the USA, Prospectively collected data from a multi-center trial in Europe and North America]
3. Number and Qualifications of Experts for Ground Truth (Test Set)
- Number of Experts: [e.g., 3]
- Qualifications of Experts: [e.g., Board-certified Prosthodontists with an average of 15 years of experience in craniomandibular disorders, Dentists specializing in sleep medicine with ≥10 years of experience]
4. Adjudication Method (Test Set)
- Adjudication Method: [e.g., 2+1 (two experts independently review and if they disagree, a third expert adjudicates), Majority vote among 3 experts, None (single expert review)]
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was a MRMC study done? [Yes/No]
- If Yes, effect size of human readers with vs. without AI assistance: [e.g., Clinicians demonstrated a 15% improvement in diagnostic accuracy with AI assistance compared to without AI assistance, or The mean time to diagnosis decreased by 20% when using the AI tool while maintaining non-inferior accuracy.]
6. Standalone Performance Study (Algorithm Only)
- Was a standalone performance study done? [Yes/No]
- If Yes, summary of results: [e.g., The algorithm achieved a sensitivity of 92% and specificity of 88% for detecting bruxism events when evaluated against polysomnography data.]
7. Type of Ground Truth Used
- Type of Ground Truth: [e.g., Expert consensus based on clinical examination and patient interviews, Diagnosis confirmed by sleep study (polysomnography) results, Objective measurements from force sensors, Patient-reported outcomes verified by follow-up clinical assessments.]
8. Sample Size for Training Set
- Sample Size for Training Set: [e.g., 500 patient records, 10,000 images, 200 hours of physiological signals]
9. How Ground Truth for Training Set Was Established
- Method for Establishing Training Set Ground Truth: [e.g., Annotated by a single experienced prosthodontist, Labeled based on confirmed clinical diagnoses from patient charts, Derived from validated questionnaires and objective sensor data.]
N/A