(190 days)
The FBCC Night Guard is indicated for protection of teeth and restorations against grinding and clenching.
The FBCC Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).
This document describes an FDA 510(k) clearance for the FBCC Night Guard. It is a submission that declares the device is "substantially equivalent" to predicate devices, meaning it does not introduce new questions of safety or effectiveness. As such, the information provided focuses on demonstrating this equivalence rather than detailing an extensive clinical study with specific acceptance criteria and performance metrics for a novel AI device.
Therefore, many of the requested elements (e.g., acceptance criteria for AI performance, sample size for test sets, expert-established ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this type of regulatory submission, as the FBCC Night Guard is a physical medical device (a mouth guard), not an AI-powered diagnostic or therapeutic device.
However, I can extract the relevant information regarding the performance testing that was conducted to support its substantial equivalence:
1. A table of acceptance criteria and the reported device performance
Since this is a physical device and a 510(k) submission based on substantial equivalence, there are no "acceptance criteria" in the traditional sense of a specified performance metric (e.g., accuracy, sensitivity, specificity) for an AI algorithm. Instead, the "acceptance criteria" were implied to be the demonstration of similarity to legally marketed predicate devices and satisfactory non-clinical performance.
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device must be substantially equivalent to a legally marketed predicate device, demonstrating similar indications for use, technological characteristics, and safety/effectiveness without raising new questions of safety or effectiveness. | The FBCC Night Guard was found substantially equivalent to the Bright Guard (K181099) and the JS Dental Lab Mouth Guard (K210011). Similarities were established in: |
- Product Code (OBR)
- Classification Panel (Dental)
- Device Class (Unclassified)
- OTC or Rx (OTC, same as predicate)
- Anatomical Sites (maxillary or mandibular teeth)
- Sterile (Non-Sterile)
- Patient Removable (Yes)
- Mechanism of Action (Disocclusion)
- Indications for Use (protection of teeth and restorations against grinding and clenching). |
| Material Safety | Material must be suitable for its intended use and not introduce new risks. | The FBCC Night Guard uses Thermoplastic Polyurethane or Ethylene-Vinylacetate. The predicate uses Thermoplastic resin (Propylene Elastomer: ethylene-vinylacetate [Elvax]). The submission states: "While these are not identical polymers, each material is a known dental thermoplastic polymer with similar characteristics. The use of thermoplastic polyurethane does not introduce or reduce any risks when compared to the other." |
| Manufacturing Process | Manufacturing process must be appropriate and not introduce new risks. | The FBCC Night Guard is Thermoforming. The predicate (Bright Guard) is Injection Molding, and the reference device (JS Dental Lab Mouth Guard) is Thermoforming. The submission states: "While these are not identical processes, both are commonly used to create mouth guards and other dental devices... The use of thermoforming does not increase the risk associated with manufacturing." An internal manufacturing validation demonstrated "dimensional accuracy of the manufacturing process" and "robustness of the process... from 3D printing through thermoforming." |
| Durability Testing | Must demonstrate suitability for the intended period of use under simulated real-world conditions. | "Durability testing was completed on these night guards. Real world use was simulated to ensure that the Night Guard material and manufacturing process produced Night Guards that were suitable for the intended period of use." (Specific quantitative results or "acceptance criteria" for durability are not provided in this summary document, but the statement indicates it passed this internal testing). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as there was no AI test set with case data. The testing mentioned (durability, manufacturing validation) would be internal laboratory testing on physical prototypes/products.
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. This device is a physical mouth guard, not an AI diagnostic/imaging device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No AI test set or clinical image review was performed for this 510(k) submission.
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 is a physical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As a physical device submission focused on substantial equivalence, the "ground truth" for the claims rested on:
- Comparison of specifications to legally marketed predicate devices.
- Results of non-clinical, mechanical, and material testing (e.g., durability, dimensional validation).
- Scientific literature supporting the use of the materials and mechanism of action for night guards.
8. The sample size for the training set
Not applicable. There is no AI model or training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set.
Summary of the Study Proving the Device Meets Criteria (Based on Provided Document):
The "study" proving the device met the criteria for 510(k) clearance was primarily a demonstration of substantial equivalence to existing predicate devices already on the market. This involved:
- Comparison of Technical Characteristics: A detailed comparison table (Table 1) was presented, highlighting similarities in product code, classification, device class, OTC status, anatomical sites, sterility, patient removability, indications for use, and mechanism of action with the Bright Guard (K181099) and JS Dental Lab Mouth Guard (K210011).
- Material Equivalence: Although different specific polymers (thermoplastic polyurethane vs. thermoplastic resin), the submission argued both are "known dental thermoplastic polymer with similar characteristics" and introduce no new risks.
- Manufacturing Process Equivalence: While the subject device uses thermoforming and the primary predicate uses injection molding, the submission highlighted that thermoforming is also used by the reference device and is a "commonly used" method that "does not increase the risk."
- Non-Clinical Performance Testing:
- Durability Testing: Simulated real-world use was conducted to ensure the night guards were suitable for the intended period of use. (Specific quantitative results were not detailed in this summary).
- Manufacturing Validation: An internal validation was performed to check the dimensional accuracy and robustness of the manufacturing process (3D printing through thermoforming).
- Conclusion: Based on these comparisons and non-clinical tests, the FDA determined the FBCC Night Guard to be "substantially equivalent" to the predicate devices, and therefore, no clinical studies were deemed necessary to demonstrate its safety and effectiveness.
N/A