(71 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable. The submission states: "No performance data is required in support of this 510(k) notice." | Not applicable. No performance data was provided or required. |
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.
N/A