(205 days)
The Bite Guard" Is used To Prevent grinding of the teeth, jaw clenching and to reduce damage to feeth from grinding .
"The Bite Guard" is a flexible and moldable dental protector which is a comfortable mouth guard as a barrier between teeth for individuals who grind their teeth. Submerging the device into boiling water allows it to be molded to fit the patient's oral cavity exclusively. "The Bite Guard" is shaped like a dental arch and is constructed of a propylene-based elastomer.
Here's a breakdown of the acceptance criteria and study information for "The Bite Guard" based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (a 510(k) summary) does not explicitly state quantitative acceptance criteria or performance metrics for this device. Instead, it relies on substantial equivalence to predicate devices. The "reported device performance" is implicitly that it performs equivalently to the predicate devices in its intended use, material properties, and manufacturing methods.
| Acceptance Criteria | Reported Device Performance (Implicitly Meets) |
|---|---|
| Safety: Biocompatibility | "The Bite Guard" relied on biocompatibility testing as the basis for non-clinical data. The testing performed on predicate devices the night guard is safe for individuals to use. |
| Effectiveness (Indication for Use): Prevent teeth grinding, reduce jaw clenching, and reduce damage to teeth from grinding. | "The Bite Guard" is substantially equivalent in safety and effectiveness...It holds up against the other mouth guards in the industry as described above." (Referring to predicate devices with the same indications for use). |
| Technology/Design: Flexible, moldable mouth guard, "boil and bite" method for fitting, injection molded manufacturing, single-patient reusable, cleaned with mouthwash or toothpaste. | "The Bite Guard" is a flexible and moldable dental protector...Submerging the device into boiling water allows it to be molded...Injection mold...Yes, Single Patient...Mouthwash or Toothpaste to clean." (Matches features of predicate devices). |
| Materials: Propylene-based elastomer/thermoplastic, non-flavored, no colored additives. | "Propylene-based Elastomer/Thermoplastic...Non - Flavored/ No colored additives." (Matches predicate device materials, with noted difference in flavoring for one predicate). |
| Shelf Life: 18 months | "Shelf Life of Device: 18 months." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical tests or specific test sets for performance were performed or reported for "The Bite Guard" itself in this submission.
- Data Provenance: Not applicable for device-specific performance testing. The review relies on existing data and regulatory clearances for the predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No new ground truth was established for a test set for "The Bite Guard" as no device-specific performance testing was conducted beyond biocompatibility.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring adjudication was used for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
- Not applicable. This device is a physical medical device (mouth guard) and not an AI/software device. Therefore, no MRMC study or AI-assisted improvement analysis was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
- None for direct device performance: The submission relies on the established safety and effectiveness of the predicate devices. The "ground truth" for showing the device meets safety and effectiveness is the substantial equivalence argument, which relies on the predicate devices having already demonstrated safety and effectiveness through their own review processes (which would have involved biocompatibility, and potentially other testing or clinical data at the time of their clearance).
- Biocompatibility ground truth: Standards for biocompatibility are used. The document mentions "biocompatibility testing" and "flow chart for Biocompatibility of Toxicity test," indicating that recognized standards and test methods for material safety were followed.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set was used.
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