(113 days)
The SleepRight® Select-Comfort™ Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
The SleepRight® Select-Comfort™ Dental Guard is indicated for the protection against teeth grinding, bruxism, and jaw clenching. Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.
The subject device is the second-generation to the SleepRight® Select-Comfort™ Dental Guard, also referred to as the SleepRight® Original (K100545) back in 2010. The SleepRight® Select-Comfort™ Dental Guard is a self-adjustable partial coverage protector that acts as a barrier between the upper and lower posterior teeth to protect the teeth against bruxism or nighttime teeth grinding. The guard contains two adjustable bite pads that are connected by a thermal band (also referred to as the strap). The bite pads contain an internal core that is fully encapsulated by a thermoplastic material; and can be adjusted in five settings: extra-small, small, medium, large, and extra-large. No boiling or microwaving is required to fit the guard to the teeth, it is ready for use right out of the package. The bite pads may be adjusted to five settings that accommodate different dental arch sizes, where the front edge of the bite pad should rest between the upper third tooth (cuspid) and the fourth tooth (premolar). For a larger fit, the bite pads can be adjusted backward; and for a smaller fit, the bite pads can be adjusted forward. The thermal band should rest between the lower lip, cheek, and gums.
The provided text describes a 510(k) premarket notification for a medical device, the SleepRight® Select-Comfort™ Dental Guard. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through comparative evaluation of materials, physical properties, biocompatibility, and wear/abrasion resistance. It does not describe a study involving an AI/algorithmic device or a human-in-the-loop study as detailed in the prompt's request.
Therefore, I cannot provide a response that includes:
- A table of acceptance criteria and the reported device performance for an AI/algorithmic device. The acceptance criteria and performance data provided are for biocompatibility testing of a physical dental guard.
- Sample size used for the test set and data provenance for an AI/algorithmic device. The data provenance described relates to material and physical property comparisons.
- Number of experts used to establish the ground truth for an AI/algorithmic device.
- Adjudication method for an AI/algorithmic device test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study and its effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used for an AI/algorithmic device.
- Sample size for the training set for an AI/algorithmic device.
- How the ground truth for the training set was established for an AI/algorithmic device.
The document is about a physical dental guard, not an AI/software device. The performance data presented are for the physical properties and biocompatibility of the dental guard.
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