(322 days)
The Night Guard is intended for protection against bruxism and nighttime teeth grinding. It is intended to reduce damage to teeth and to prevent the noise associated with bruxing and grinding.
NightGuard is a soft, comfortable, mouth guard 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. NightGuard is a full coverage device which covers the occlusal surfaces of all the upper teeth.
The provided text describes a 510(k) submission for a non-diagnostic medical device (a mouth guard), not an AI/ML-enabled diagnostic device. Therefore, the typical acceptance criteria and study design elements requested in the prompt, which are relevant to AI/ML device performance evaluation, are largely not present in this document.
However, I will extract the information that is present concerning the device's "performance" in the context of this 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (NightGuard mouth guard), the "acceptance criteria" and "performance" are framed around substantial equivalence to predicate devices, rather than quantitative performance metrics like sensitivity or specificity. The primary "performance" characteristic is its ability to serve the intended use.
| Acceptance Criteria (Implicit for 510(k) Equivalence) | Reported Device Performance (NightGuard) |
|---|---|
| Indications for Use: Protection against bruxism and nighttime teeth grinding; reduce damage to teeth; prevent noise associated with bruxing and grinding. | Same as predicate devices (Doctor's Nightguard, Ez Splint PM, Dr Hays Bite Guard) |
| Design: Adjustable Pre-formed oral device | Same as predicate devices |
| Materials: Thermoplastic Resin | Thermoplastic Resin (Same as predicate Doctor's Night Guard) |
| Method of Manufacture: Injection Molded | Same as predicate devices (Ez Splint PM, Dr. Hays Bite Guard are also molded, though Dr. Hays is dental laboratory molded) |
| Prescription Device: No | No (Same as predicate Doctor's Night Guard) |
| Reusable: Yes, single patient | Yes, single patient (Same as predicate devices) |
| Method of Disinfection: Warm water, soap and air dry | Same as predicate devices |
Study That Proves the Device Meets the Acceptance Criteria:
Based on the provided document, no specific study was performed to "prove" the device meets acceptance criteria in the context of performance metrics. For this 510(k) submission, the "proof" is established through a comparison to legally marketed predicate devices to demonstrate substantial equivalence.
Here's why and what was reported:
- Non-Clinical Tests Performed: "No non-clinical tests were preformed for the determination of substantial equivalence."
- Clinical Tests Performed: "No clinical tests were preformed for the determination of substantial equivalence."
- Conclusions Drawn From Non-Clinical and Clinical Tests: "No conclusions were drawn from Non-clinical and Clinical Test."
- Overall Conclusion: "NightGuard is as safe, as effective, and performs as well as or better than the predicated device." This conclusion is drawn purely from the narrative and tabular comparison of features with the predicate devices, not from direct testing of the NightGuard itself.
Given that this is a 510(k) for a non-diagnostic, non-AI device, the subsequent questions are not applicable. I will explicitly state why for each:
2. 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 test set or data was used as no clinical or non-clinical studies were performed for this 510(k). The determination was based on comparison to predicate devices.
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. No test set was used, and therefore no ground truth was established by experts for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set was used.
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 not an AI/ML diagnostic. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. No ground truth was established as no performance studies were conducted. The "ground truth" for the 510(k) submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device and does not have a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device and does not have a training set.
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