(264 days)
The Goyo Mouthpiece S is indicated for use as a protection against bruxism or nighttime teeth grinding. The device is designed to reduce tooth damage and reduce the noise associated with bruxism or teeth grinding.
The mouthguard is an over-the-counter, flexible and moldable, one-piece dental mouthguard used as a barrier between the teeth for individuals who wish to prevent teeth grinding during sleep. The Goyo Mouthpiece S is made of ethylene vinyl acetate (EVA). The mouthguard material is conformable to wear and it can be self-fitting by heating the mouthguard in boiling water until it becomes malleable to fit on the upper teeth of the oral cavity. The Goyo Mouthpiece S comes in one model/size, is reusable by a single individual eighteen (18) years of age or older, and is supplied non-sterile. The wearing period of the mouse guard is generally not more than twelve (12) hours a day and it is recommended to replace it with the new mouthguard in the one (1) month.
This document is an FDA 510(k) Premarket Notification for the "Goyo Mouthpiece S", a device indicated for protection against bruxism or nighttime teeth grinding. The submission aims to demonstrate substantial equivalence to a predicate device (K133423, Rest Assured® Extra Comfort Nite Protector / Ranir, LLC).
Based on the provided text, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
No clinical performance data was provided for this device. The submission relies on non-clinical performance data (biocompatibility and mechanical testing) to demonstrate substantial equivalence to the predicate device, stating that the differences do not affect safety and effectiveness. Therefore, the questions related to clinical study design, sample size, expert involvement, and ground truth for a clinical test set are not applicable here.
Device Performance and Acceptance Criteria Breakdown:
The acceptance criteria for this device are implicitly tied to demonstrating that its performance characteristics are comparable to the predicate device and that it is safe and effective for its indicated use. The studies performed are non-clinical (biocompatibility and mechanical testing).
No specific quantitative acceptance criteria targets (e.g., "accuracy > 90%") are stated for the Goyo Mouthpiece S in this document. Instead, the document states that "All test results for appearance, dimensions, Shore A hardness, tensile strength, tear strength, water sorption, and water solubility were similar to that of the predicate device." and that "The performance characteristics of the subject device are comparable to those of the predicate device for this particular indication and raise no new or different questions of safety and effectiveness."
Here's a table summarizing the reported device performance where applicable, compared to the predicate:
| Acceptance Criteria (Implicit) | Reported Device Performance (Goyo Mouthpiece S) | Predicate Device Performance (K133423) | Conclusion / Comparison |
|---|---|---|---|
| Material Composition | Ethylene Vinyl Acetate Copolymer [Elvax] | Ethylene Vinyl Acetate Copolymer [Elvax and Elvaloy] | Similarities: Both are dental thermoplastic polymers with similar characteristics. Difference (Elvaloy presence in predicate) does not affect safety and effectiveness. |
| Biocompatibility (per ISO 10993-1, battery of tests) | Biocompatible for Cytotoxicity, Sensitization, and Irritation | Biocompatible according to ISO 10993-1 | No difference. Both meet ISO 10993-1. |
| Appearance | Not explicitly detailed, but tested. | Not explicitly detailed, but tested. | "Similar" to predicate. |
| Dimensions (Width) | Avg. 70.38mm | Avg. 66.6mm | Similarities: Subject device is larger but "thinner" and does not introduce additional safety/efficacy concerns. Mechanical testing showed similarity. |
| Dimensions (Length) | Avg. 47.32mm | Avg. 43.72mm | Similarities: Subject device is larger but "thinner" and does not introduce additional safety/efficacy concerns. Mechanical testing showed similarity. |
| Shore A Hardness | Not explicitly specified, but tested. | Not explicitly specified, but tested. | "Similar" to predicate. |
| Tensile Strength | Not explicitly specified, but tested. | Not explicitly specified, but tested. | "Similar" to predicate. |
| Tear Strength | Avg. 60.3 ± 4.13 N | Avg. 58.6 ± 4.92 N | Similarities: Very close numerical values, falling within expected variation. |
| Water Sorption | Not explicitly specified, but tested. | Not explicitly specified, but tested. | "Similar" to predicate. |
| Water Solubility | Not explicitly specified, but tested. | Not explicitly specified, but tested. | "Similar" to predicate. |
Study Details (Non-Clinical Performance Data):
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact number of samples used for each mechanical test (e.g., 'n=' for tensile strength, tear strength, etc.). It only provides average values and standard deviations for tear strength.
- Data Provenance: The tests were performed to support substantial equivalence to a predicate device. The location of the testing laboratories is not explicitly stated, but the manufacturer (DIMEDIKOREA) is based in South Korea, and the correspondent (SMB Korea) is also in South Korea. The data would be considered retrospective as it was collected to support the premarket notification.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission relies on objective physical and chemical property testing (biocompatibility and mechanical testing) rather than expert-derived ground truth from interpreting medical images or clinical outcomes.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept relates to human assessment and consensus, which is not part of the non-clinical testing performed.
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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 mouthguard, not an AI-powered diagnostic or assistive tool for human readers.
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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 device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Test Standards: The "ground truth" for the non-clinical tests (biocompatibility, mechanical properties) is adherence to recognized international standards (e.g., ISO 10993-1 for biocompatibility) and comparison to the known characteristics of the legally marketed predicate device.
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The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not an AI/machine learning algorithm.
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How the ground truth for the training set was established:
- Not applicable. (See point 7).
Summary of Approach:
The FDA 510(k) submission for the Goyo Mouthpiece S relied on a direct comparison of the device's technical characteristics and non-clinical performance data (biocompatibility and mechanical properties) to a legally marketed predicate device (K133423). The argument for substantial equivalence is based on the premise that any minor differences in material composition or dimensions do not raise new questions of safety or effectiveness, as demonstrated by the comparable performance in standard physical and chemical tests. Clinical performance data was explicitly stated as not having been provided, indicating that the non-clinical data was deemed sufficient to establish substantial equivalence for this type of device.
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