(230 days)
The Oral B plus Scope Outlast Nighttime Dental Guard is an Over-the-Counter dental guard indicated for the protection against bruxism - the nighttime clenching and grinding of the teeth.
It is intended for use in the mouth at night to reduce damage to the teeth and to prevent the noise associated teeth grinding.
a mouthguard constructed of a propylene-based elastomer. The target area is the oral cavity of individuals that suffer from bruxism, nighttime teeth grinding.
The device works by molding the thermoplastic resin to the individual's mouth. The thermoplastic resin can be molded after submerged in boiling water via the microwave. The molded thermoplastic resin is worn at to reduce damage to the teeth and to prevent the noise associated teeth grinding.
OraLabs Oral-B plus Scope Outlast Nighttime Dental Guard is intended for individuals age 18 and older. Thermoplastic can be molded to fit all sizes.
This 510(k) submission (K113326) for the Oral-B plus Scope Outlast Nighttime Dental Guard focuses on biocompatibility testing as its primary performance data because it is a medical device, and the device is claiming substantial equivalence to a predicate device (Dentek's Custom Comfort Dental Guard, K083400) which would have already established its functional efficacy for bruxism. Therefore, the acceptance criteria and study described here are centered on ensuring the safety of the new device for human contact, particularly due to the addition of flavor.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | MEM Elution (Cytotoxicity) | Pass (Non-cytotoxic) | Passed |
| Guinea Pig Maximization Sensitization Test | Pass (Non-sensitizing) | Passed | |
| Intracutaneous Irritation Test | Pass (Non-irritating) | Passed | |
| Acute Systemic Injection Test | Pass (No acute systemic toxicity) | Passed | |
| SubChronic (14-day) Intravenous Toxicity Study | Pass (No subchronic systemic toxicity; acceptable hematology & clinical chemistry) | Passed | |
| Material Composition | Propylene-based elastomer | Same as predicate device | Same as predicate device |
| Functional Characteristics | Physical Barrier for Teeth | Maintain physical barrier characteristics as predicate device | Does not change physical barrier characteristics from the predicate device |
| Flavor Additive | Mint flavor sensation | (Implied: Provides mint-flavored sensation upon use without impacting safety or efficacy) | Provides mint-flavored sensation upon use |
2. Sample Size Used for the Test Set and Data Provenance:
The study primarily involved biocompatibility testing on biological models, not a human clinical test set in the traditional sense for efficacy.
- MEM Elution (Cytotoxicity): L-929 Mouse Fibroblast Cells
- Guinea Pig Maximization Sensitization Test: Not explicitly stated, but typically involves a number of guinea pigs (e.g., 10-20 per group).
- Intracutaneous Irritation Test: 3 Rabbits
- Acute Systemic Injection Test: Not explicitly stated, but typically involves a number of animals (e.g., mice).
- SubChronic (14-day) Intravenous Toxicity Study: Non-Swiss Webster Mice (number not specified, but usually involves multiple groups with a control).
Data Provenance: The studies are laboratory-based biocompatibility tests, not tied to a specific country of origin for human data or retrospective/prospective human studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable in the context of this biocompatibility study. The "ground truth" for these tests is established by recognized international standards (ISO 10993 series) and laboratory best practices, not expert consensus on human cases.
4. Adjudication Method for the Test Set:
Not applicable. Biocompatibility tests have specific endpoints and interpretations as outlined in the ISO standards. The results are typically quantitative or qualitative (pass/fail) based on established thresholds, not subject to expert adjudication of individual cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This submission is for a physical medical device (dental guard) where the primary concern is safety and functional equivalence, not diagnostic accuracy requiring human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
Not applicable. This device is a physical dental guard, not an algorithm or AI system.
7. Type of Ground Truth Used:
The ground truth used for this submission is based on International Standards (ISO 10993 series) for biocompatibility. These standards define the acceptable biological responses to medical devices.
8. Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of this device and the type of performance testing performed. AI/ML models use training sets, but this is a physical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
N/A