(156 days)
OTC:
- Protection against bruxism or night time teeth grinding
- Reduce damage to the teeth and reduce the noise associated with bruxing and/or grinding.
Rx:
- Protection of teeth grinding, bruxism, and jaw clenching.
- Protection of restorations from injury due to bruxism or clenching.
- Relief of bruxism related headaches and pains.
- Short-term pain relief from muscle spasm 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 mandibular and maxillary teeth by the temporalis muscle.
- Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
The SmartGuard® is a dental night guard composed of Elvax and once this thermoplastic material is submerged in hot water (see molding instructions) it softens and conforms to the individual's anterior maxillary teeth from first bicuspid. SmartGuard® is designed to be worn on the anterior, upper 6 to 8 teeth, preventing the posterior teeth from coming into occlusion, which relaxes the jaw muscles and helps to reduce jaw clenching and grinding and reduces the associated symptoms. The lower bottom anterior teeth bite against the bottom of the substrate with the ability to slide around freely as the device reduces posterior teeth cuspal interferences. The design features of SmartGuard® allow patients to easily mold this device at home or in a prescribing office, to fit their teeth properly. The SmartGuard® is designed to be worn at night and not longer than 12 consecutive hours in a 24 hour period.
SmartGuard® Original and SmartGuard Elite® differ slightly in design, with the primary difference being in the width of the palatal ex-tension, (Original 21mm and Elite 30 mm) as well as the distance between the outer rim and mesial/occlusal surface of the palatal extension (Original 10 mm and Elite 9 mm). The SmartGuard Elite® was designed to fit the majority of individuals mouths. However, if the patient has a small mouth or has a sensitive gag reflex, the SmartGuard® Original might be a better fit.
This document is a 510(k) premarket notification for the SmartGuard® Night Guard, SmartGuard® Original, SmartGuard® Night Guard Original and SmartGuard Elite™ dental guards. The document outlines the device description, intended use, and a comparison to predicate devices, ultimately demonstrating substantial equivalence.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" with specific numerical targets. Instead, the entire submission is based on demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" is therefore implied to meet the same level of safety and effectiveness as the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| OTC Indications: | |
| - Protection against bruxism or night time teeth grinding | "identical in design and material to the OTC devices cleared...same intended uses, indications, and similar technological characteristics." |
| - Reduce damage to the teeth and reduce noise associated with bruxing and/or grinding. | "identical in design and material to the OTC devices cleared...same intended uses, indications, and similar technological characteristics." |
| Rx Indications: | |
| - Protection of teeth grinding, bruxism, and jaw clenching. | "same intended uses, indications and similar technological characteristics as its predicate devices." |
| - Protection of restorations from injury due to bruxism or clenching. | "same intended uses, indications and similar technological characteristics as its predicate devices." |
| - Relief of bruxism related headaches and pains. | "same intended uses, indications and similar technological characteristics as its predicate devices." |
| - Short-term pain relief from muscle spasm due to occlusal interference; for the prevention of chronic tension and temporal mandibular joint (TMJ) syndrome... | "same intended uses, indications and similar technological characteristics as its predicate devices." |
| - Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains. | "same intended uses, indications and similar technological characteristics as its predicate devices." |
| Safety: | "The minor technological differences between SmartGuard® and the predicate devices raise no new questions of safety or effectiveness." |
| Effectiveness: | "The minor technological differences between SmartGuard® and the predicate devices raise no new questions of safety or effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific test set or clinical study with a sample size for the SmartGuard® device itself. The claim of substantial equivalence is based on a comparison of technical characteristics, design, materials (Elvax), and intended uses to already cleared predicate devices. There is no mention of a clinical trial or performance study on human subjects with the SmartGuard® device to establish its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there is no described test set or clinical study for the SmartGuard® device itself, there were no experts used to establish ground truth in this context. The "ground truth" for the predicate devices' safety and effectiveness would have been established during their respective clearance processes, which are not detailed here.
4. Adjudication Method for the Test Set
Since no specific test set or clinical study is described for the SmartGuard® device, no adjudication method is mentioned or applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC comparative effectiveness study was done as part of this 510(k) submission. This type of study is typically used for diagnostic devices where human readers interpret medical images or data, and an AI's impact on their performance is being evaluated. This submission pertains to a physical dental device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The SmartGuard® is a physical dental device, not an algorithm or AI system. Its performance is inherent in its design and material properties, intended for direct use by the patient or under doctor's guidance, not as a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The SmartGuard® is deemed substantially equivalent because it shares the same intended uses, similar technological characteristics, and material composition with these cleared predicate devices, asserting that it raises "no new questions of safety or effectiveness."
8. The Sample Size for the Training Set
There is no training set described as this is not an AI/machine learning device. The design and materials are based on existing dental guard technologies.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set mentioned in the document for an AI/machine learning device.
N/A