(88 days)
Prescription Indications for Use:
. Protection against teeth grinding, bruxism & jaw clenching.
Short-term pain relief from muscle spasm due to occlusal interference. .
For the prevention of chronic tension and TMJ caused by chronic jaw clenching of . the mandibular and maxillary teeth by the temporalis muscle.
OTC Indications for Use:
The SleepRight® adjustable night guard is indicated for the protection against bruxism or night time teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
An adjustable protector that provides a barrier between the upper and lower posterior teeth. The flexible connecting strap provides 4 adjustments for articulating bite pads.
This document is a 510(k) premarket notification for a medical device called "SleepRight® -Select, SleepRight®-Low Profile and SleepRight®-Advance, SleepRight® - Low Profile Rx and SleepRight® - Advance Rx". It is a mouthguard/nightguard intended for protection against teeth grinding (bruxism) and jaw clenching, and for short-term pain relief from muscle spasms.
The document does not describe a study that establishes acceptance criteria and then proves the device meets those criteria. Instead, it describes a substantial equivalence determination, comparing the device to legally marketed predicate devices.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance. (This is irrelevant, as the device is not an AI-assisted diagnostic tool).
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done (This is irrelevant, as the device is not an algorithm).
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
Key Information from the Document:
The document focuses on establishing substantial equivalence to existing predicate devices based on:
- Identical Indications for Use (OTC):
- Subject Device (SleepRight®): Protection against bruxism or nighttime teeth grinding. Intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
- Predicate Device (Doctor's NightGuard): Protection against bruxism or nighttime teeth grinding. Intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
- Similar Indications for Use (Rx):
- Subject Device (SleepRight® Rx): Protection against teeth grinding, bruxism & jaw clenching; Short-term pain relief from muscle spasm due to occlusal interference; Prevention of chronic tension and TMJ caused by chronic jaw clenching.
- Predicate Device (EZ Splint): Protection against teeth grinding, bruxism & jaw clenching; Short-term pain relief from muscle spasm due to occlusal interference; Prevention of chronic tension and TMJ caused by chronic jaw clenching.
- Physical Characteristics: Materials (Elvax® strap, Polyurethane/Pellethane bite pads for Advance; Polypropylene/Kraton® bite pads for Select/Low Profile) are compared to predicates.
- Method of Manufacture: Both are "Injection Molded" (same as predicates).
- Design: Shared similarities with the EZ Splint (partial coverage, preformed oral appliance with adjustable bite pads, no boiling required), distinguishing it from the Doctor's NightGuard (full coverage, boil and bite technology).
- Reusability: "Yes, single consumer" (same as predicates).
The FDA determined that the device is substantially equivalent to legally marketed predicate devices, which allows it to be marketed. This determination is not based on performance data against acceptance criteria in the way a clinical trial for a novel drug or a new AI diagnostic algorithm would be. Instead, it relies on the similarities in indications, technological characteristics, and safety profiles to already cleared devices.
N/A