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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

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.]

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The Doctor's NightGuard 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 is composed of a soft, formable clear upper material, made of ELVAX® resin, a copolymer of ethylene and vinyl acetate, and a hard occlusal base, which cushions the teeth. The base is composed of 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.

This 510(k) summary for the Doctor's® NightGuard™ explicitly states that no performance data is required to support the 510(k) notification. The device's substantial equivalence is primarily based on its similarity to legally marketed predicate devices, not on a new study demonstrating its efficacy or performance against specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria and study design are not applicable in this case.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable. No test set was used for a performance study. The substantial equivalence was based on technological characteristics and intended use in comparison to predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Not applicable. No ground truth was established through expert review for a performance study.

4. Adjudication Method for the Test Set:

• Not applicable. No adjudication method was used as there was no test set requiring ground truth establishment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study was not conducted or reported.

6. Standalone (Algorithm Only) Performance Study:

• No. This device is a physical dental protector, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

• Not applicable. No ground truth was used for a performance study. The substantial equivalence argument relies on comparing the device's design, materials, and intended use to existing devices.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical product and does not involve a training set as would be found in artificial intelligence or machine learning applications.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, there is no training set for this type of device.

Summary of the Device's Substantial Equivalence Justification:

The Doctor's® NightGuard™ achieved substantial equivalence by demonstrating that it is:

• Physically the same as the predicate device, Dental Concepts' BruxGuard.
• Composed of similar materials (ELVAX® resin and Elvaloy® copolymer) with similar technological characteristics.
• Has a similar intended use (protection against bruxism) as the predicate devices, including the BruxGuard, Hollywood Products Mouth Peace, and GEM Scientific Products, Inc. Tension Reliever.
• Revised its labeling to be suitable for Over-The-Counter (OTC) use, aligning with the OTC status of some predicate devices.

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