(98 days)
The SleepRight® Original 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 5 adjustments for the bite pads.
The provided document, K100545, is a 510(k) summary for the SleepRight® Original Mouthguard, which is a device intended for the protection against bruxism or nighttime teeth grinding. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the SleepRight® -Low profile (K071404).
Based on the provided text, there is no acceptance criteria or a study described that proves the device meets specific acceptance criteria in the typical sense of a clinical trial with quantitative endpoints like sensitivity, specificity, or improvement in human reader performance. This 510(k) summary is a premarket notification for a Class I/Unclassified device, and the primary focus is on demonstrating "substantial equivalence" to a predicate device rather than presenting a performance study against predefined acceptance criteria.
The submission highlights comparisons of technical characteristics to a predicate device. This is a common approach for unclassified or Class I devices seeking 510(k) clearance, where safety and effectiveness are established by showing the new device is as safe and effective as a device already on the market.
Here's an analysis based on your requested information, acknowledging the limitations of a 510(k) summary for this type of device:
1. A table of acceptance criteria and the reported device performance
As stated above, this document does not present specific quantitative acceptance criteria and device performance metrics (e.g., accuracy, sensitivity, specificity) as one would find for an AI/clinical diagnostic device. Instead, the "acceptance" is based on demonstrating "substantial equivalence" to a predicate device across various features.
The key "performance" reported is essentially the similarity of the device to the predicate device in terms of its intended use, design, materials, and other characteristics.
Here's a table summarizing the comparison of the subject device (SleepRight® Original) to the predicate device (SleepRight® -Low profile), which serves as the basis for substantial equivalence:
| Element of Comparison | Acceptance Criteria (based on predicate) | Reported Device Performance (SleepRight® Original) |
|---|---|---|
| Device Description | An adjustable protector that provides a barrier between upper/lower posterior teeth. Flexible connecting strap provides 4 adjustments for articulating bite pads. | An adjustable protector that provides a barrier between upper/lower posterior teeth. Flexible connecting strap provides 5 adjustments for the bite pads. |
| Material (Strap) | Elvax® strap | Elvax® strap |
| Material (Bite Pads) | Polypropylene and Kraton® bite pads | Polypropylene bite pads |
| Thermal Safety | Warm water (not boiling) recommended for fitting. | Same (Implied, as "Same" is stated for Thermal Safety) |
| Method of Manufacture | Injection Molded | Same (Implied, as "Same" is stated for Method of Manufacture) |
| Rx or OTC | Rx and OTC | OTC |
| Reusable | Yes, single patient | Same (Implied, as "Same" is stated for Reusable) |
| Sterile | No | Same (Implied, as "Same" is stated for Sterile) |
| Method of Disinfection | Cool water, mouthwash or toothpaste. | Same (Implied, as "Same" is stated for Method of Disinfection) |
| Design | Partial coverage, preformed oral appliance with adjustable bite pads. No boiling required. | Same except bite pads do not articulate. |
| Compatibility with Environment & Other Devices | Biocompatible materials used. | Same (Implied, as "Same" is stated for Compatibility) |
| Indications for Use | Protection against bruxism or nighttime teeth grinding. Intended to reduce damage to teeth and prevent noise associated with bruxing or grinding. | Same |
| Target Population | Individuals over 18 who clench and grind their teeth. | Same |
| Where used | For home use. | Same |
| Flavored | Yes | No |
Summary of "Performance": The device's "performance" is considered acceptable because it shares the same fundamental scientific technology, intended use, and similar design and operating principles as the predicate device, with minor differences that do not raise new questions of safety or effectiveness. Notable differences (e.g., 5 adjustments vs. 4, Polypropylene only vs. Polypropylene and Kraton for bite pads, Not flavored vs. flavored) are implicitly deemed not significant enough to alter substantial equivalence.
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. This document does not describe a test set or data from a study with a sample size for performance evaluation. The submission relies on a comparison of technical characteristics to a predicate device.
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 or ground truth established by experts is mentioned in this 510(k) summary. The ground for acceptance is substantial equivalence to a previously cleared device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is mentioned.
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 a mouthguard, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader improvement are not relevant and not documented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical mouthguard, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The concept of "ground truth" as typically applied in AI/diagnostic studies is not relevant here. The basis for clearance is the demonstrated substantial equivalence to a predicate device which has already established its safety and effectiveness for the intended use.
8. The sample size for the training set
- Not applicable. This device is a physical product, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set or ground truth establishment is relevant to this type of device submission.
N/A