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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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The Dental Concepts Bite Plate is indicated for protection against bruxism (nighttime teeth grinding) and jaw clenching during sleep, short-term pain relief from muscle spasm due to occlusal interference, and prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary tecth by the temporalis muscle.

Dental Concepts' Bite Plate is a soft, comfortable, custom-fit protector intended to provide a barrier between the teeth for those patients who grind their teeth at night (bruxism). The product is shaped like a dental arch and is available in three sizes, but can be trimmed to fit more comfortably.

Here's an analysis of the provided 510(k) summary regarding the Dental Concepts Bite Plate, focusing on acceptance criteria, device performance, and study details.

Important Note: The provided document is a 510(k) summary for a medical device (Dental Concepts Bite Plate) seeking clearance from the FDA. A 510(k) notification primarily aims to demonstrate substantial equivalence to a predicate device, rather than proving that the new device meets specific, quantitative "acceptance criteria" through a comprehensive clinical study in the way a PMA (Pre-Market Approval) submission might. Therefore, the information typically found in a 510(k) differs significantly from what one would expect for a study proving device performance against detailed acceptance criteria using metrics like sensitivity, specificity, or AUC.

Based on the provided text, a conventional "study that proves the device meets the acceptance criteria" in terms of clinical efficacy metrics (like those used for AI/diagnostic devices) was not performed or reported in this 510(k) summary. The summary focuses on demonstrating substantial equivalence in terms of materials, intended use, and technological characteristics to a legally marketed predicate device.

Analysis of the Dental Concepts Bite Plate 510(k) Summary

Here's a breakdown of the requested information, acknowledging the limitations of a 510(k) summary for this type of query:

1. A table of acceptance criteria and the reported device performance

As explained above, this 510(k) does not present acceptance criteria in terms of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) or the results of a clinical study designed to meet them. Instead, the "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to a predicate device.

• Both devices are intended to be custom-fit dental protectors.
• Both are composed of thermoplastic resins that can be molded to fit the mouth.
• The Bite Plate has a soft, formable clear upper material and a base material, both of thermoplastic resin, which can be molded when heated. The predicate, Dr. Hays Bite Guard, is composed of a single thermoplastic resin, also custom-fittable.
• Minor dimensional differences are noted, but the Bite Plate can be trimmed for comfort.
• Biocompatibility Assessment: A biocompatibility assessment was performed on the materials of the Bite Plate with satisfactory results, addressing a key safety aspect related to materials. |
  | 3. Safety & Effectiveness: The device is as safe and effective as the predicate device. For 510(k), this is demonstrated via substantial equivalence rather than independent clinical trials for efficacy. | Reported Performance: The FDA's clearance (MAR 26 2003 letter) states they "have determined the device is substantially equivalent... to legally marketed predicate devices." This is the primary "proof" of meeting safety and effectiveness criteria in a 510(k) context. The biocompatibility assessment contributed to this finding. No clinical efficacy data directly comparing the new device against the predicate or a placebo is provided. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• No "test set" in the context of a clinical performance study is described. The 510(k) summary does not report on a study involving a patient test set to evaluate the device's clinical performance. The assessment focuses on comparison to a predicate device.
• The only "test" mentioned is a biocompatibility assessment of the materials. No sample size or data provenance details are given for this assessment in the summary, other than "satisfactory results."

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. As there was no clinical performance test set described, there were no experts used to establish ground truth in the context of evaluating diagnostic or treatment efficacy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical performance test set requiring adjudication was described.

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 physical dental protector/splint, not an AI-assisted diagnostic or therapeutic device. Therefore, an MRMC study for AI assistance is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a physical dental protector. No algorithm or standalone performance evaluation was conducted.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable in the context of clinical performance evaluation. For the biocompatibility assessment, the "ground truth" would be established by standard toxicology and material science testing protocols according to relevant ISO/FDA guidance, with results interpreted against established safety thresholds.

8. The sample size for the training set

• Not applicable. There was no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable. As above, no training set for an algorithm was involved.

Summary of Device Acceptance without Clinical Efficacy Study:

The Dental Concepts Bite Plate received 510(k) clearance by demonstrating substantial equivalence to an already legally marketed predicate device (Dr. Hays Bite Guard) regarding its intended use and technological characteristics, and by providing a satisfactory biocompatibility assessment. This type of submission relies on the established safety and effectiveness of the predicate device, rather than requiring new, extensive clinical efficacy trials for the new device itself. The FDA's letter is the "proof" that the device met the requirements for 510(k) clearance.

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