(73 days)
- Protecting against teeth grinding, bruxism and jaw clenching.
- Short-term pain relief from muscle spasm pain due to occlusal interference.
- For the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the posterior mandibular and maxillary teeth by the temporalis muscle. The device is custom made for the individual.
The Dr. Hays Bite Guard is designed to assist in the treatment of occlusal disorders resulting in teeth grinding, jaw clenching, and mandibular muscle spasm. The device is comprised of a thin horseshoe shaped plastic (polycarbonate, Lexan) tray filled with a thermoplastic agent (Elvax). The device is supplied to health care practioners to heat, mold, and otherwise custom fit and trim each device to the patient. Materials: the Dr. Hays Bite Guard is made of Lexan and Elvax, the same materials as the Snore Guard device, cleared under K882303. The device is supplied Non-Sterile. The device is packaged in "clean only" condition but is free of manufacturing debris and/or residues. Components are inspected after processing to evaluate and document the removal of manufacturing residue and debris. However, it is recommended that the device be removed from its shipping and packing materials and washed with warm soap and water before use. The device may not be autoclaved.
This submission (K014079) for the Dr. Hays Bite Guard is a 510(k) Premarket Notification, meaning the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, rather than requiring a detailed study demonstrating performance against specific acceptance criteria.
Therefore, the provided document does not contain a study with acceptance criteria and reported device performance in the way a clinical trial or performance study would typically be presented for novel devices or those requiring PMA. Instead, the submission relies on demonstrating that the Dr. Hays Bite Guard is substantially equivalent to existing devices.
Here's an analysis based on the information provided, highlighting why certain requested criteria are not applicable:
Summary of Acceptance Criteria and Device Performance (Not Applicable for 510(k) Substantial Equivalence)
Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" defined for this new device's performance in the document, nor a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or performance study. The "acceptance criteria" for a 510(k) is the demonstration of substantial equivalence to a predicate device.
The table below illustrates the comparison made for substantial equivalence, which serves as the basis for clearance, rather than a performance study outcome for the specific device being submitted.
| Feature | Dr. Hays Bite Guard Performance (Claimed Equivalence) | Basis for Equivalence/Predicate Device(s) |
|---|---|---|
| Intended Use & Indications for Use | Protecting against teeth grinding, bruxism, jaw clenching; short-term pain relief from muscle spasm pain due to occlusal interference; prevention of chronic tension and TMJ syndrome caused by chronic jaw clenching. Custom made for individual. | SnoreGuard™ (K882303), Best Bite Decluder™ (K980953), NTI Clenching Suppression System (K981546). Claimed to be the Same. |
| Materials | Lexan & Elvax | SnoreGuard™ (K882303) also uses Lexan & Elvax. Other predicates use "Thermoplastic". Claimed to be the Same/Similar. |
| Design | Custom molded mouth guard | SnoreGuard™, Best Bite Decluder™, NTI System all described as "Same" design. Claimed to be the Same. |
| Prescription Device | Yes | All predicates are "Same" (Prescription). Claimed to be the Same. |
| Reusable | Yes - Single patient | All predicates are "Same" (Reusable). Claimed to be the Same. |
| Method of Disinfection | Warm water, soap & toothbrush | All predicates are "Same". Claimed to be the Same. |
Detailed Analysis of Requested Information:
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A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. As explained above, for a 510(k) substantial equivalence submission, the "acceptance criteria" is the demonstration of similarity to predicate devices in terms of intended use, indications for use, technological characteristics (materials, design), and safety/effectiveness profiles. The table above summarizes how the Dr. Hays Bite Guard compares to its predicates, which is the basis of its "performance" for regulatory clearance in this context.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No explicit "test set" or clinical data is mentioned for the Dr. Hays Bite Guard itself in this 510(k) summary. The submission relies on the established safety and effectiveness of the predicate devices.
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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. No ground truth establishment by experts for a specific test set for the Dr. Hays Bite Guard is mentioned. The ground truth, in a broader sense, for the predicate devices' safety and effectiveness would have been established historically, but not for this specific submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No specific test set to adjudicate is mentioned.
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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 appliance, not an AI or imaging diagnostic tool. Therefore, MRMC studies and AI-related metrics are irrelevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable for this specific submission. The "ground truth" for this 510(k) is the demonstrated safety and effectiveness of the predicate devices that have been legally marketed. The submission does not provide new clinical data or specific ground truth for the Dr. Hays Bite Guard.
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The sample size for the training set
- Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning or algorithms.
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How the ground truth for the training set was established
- Not Applicable. There is no training set for this device submission.
Conclusion:
The K014079 submission for the Dr. Hays Bite Guard is a 510(k) Premarket Notification, which means its clearance is based on demonstrating "substantial equivalence" to one or more legally marketed predicate devices. It does not include a novel study with specific acceptance criteria that the device's performance was measured against, nor does it involve AI, imaging, or complex reader studies. The primary "study" in this context is the comparison table demonstrating the device's similarity to its predicates, SnoreGuard™ (K882303), Best Bite Decluder™ (K980953), and NTI Clenching Suppression System (K981546), across key features like indications for use, materials, and design.
N/A