(232 days)
Prescription indications: To protect against tooth damage bruxism and clenching caused by occlusal interferences, Provide short term relief from muscle spasm due to occlusal interferences, and Prevention of pain and chronic tension of temporomandibular joint syndrome components that are caused by chronic jaw clenching.
The Grind Guard is appliance is to be worn at night, covering the teeth of the upper arch. It is composed of a soft, thermoformable material that is heated and briefly cooled and molded to fit user's upper teeth; shock-absorbing material cushions teeth on all sides. This device may not be used as an athletic mouth guard. This device should not be used by persons under the age of 18.
The provided text does not contain detailed acceptance criteria or a specific study proving the device meets said criteria in the format requested. The document is a 510(k) summary for a medical device (Grind Guard), focusing on its substantial equivalence to predicate devices rather than reporting on a de novo clinical trial with specific performance metrics.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Explicit quantitative acceptance criteria are not provided in the document. | The device is stated to be effective for the relief of orofacial pain associated with temporomandibular disorders, as supported by an independent clinical study published by JADA. No specific metrics (e.g., percentage reduction in pain, success rate) are given. |
Missing Information: There are no explicit, quantifiable acceptance criteria (e.g., "device must reduce pain by X% in Y% of patients"). The document instead relies on a claim of "effectiveness" supported by a published study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only states "An independent clinical study published by JADA supports the effectiveness."
- Data Provenance (country of origin, retrospective/prospective): Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable, as this device does not involve expert image interpretation or diagnosis. The "ground truth" would likely be patient-reported outcomes or clinical assessments.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Since this is not a diagnostic device requiring expert review of results, an adjudication method for a test set (like 2+1 for image interpretation) is not relevant to the information provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC study was not done. The device is a "mouthguard, prescription" and not an imaging or diagnostic AI tool that would typically involve human readers.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as it's not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study
- Standalone Study: Not applicable. This is a physical medical device (mouthguard), not an algorithm or AI system.
7. Type of Ground Truth Used
- Type of Ground Truth: The document implies that the effectiveness was assessed through clinical outcomes, specifically "relief of orofacial pain associated with temporomandibular disorders." It does not specify whether this was patient-reported, physician-assessed, or a combination. The "independent clinical study published by JADA" would contain these details.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for the Training Set was Established: Not applicable, as it's not a machine learning model.
Summary of Device-Specific Information from the Text:
- Device Name: Grind Guard
- Indications for Use:
- Protect against tooth damage from bruxism and clenching due to occlusal interferences.
- Provide short-term relief from muscle spasm due to occlusal interferences.
- Prevention of pain and chronic tension of temporomandibular joint syndrome components caused by chronic jaw clenching.
- Proof of Effectiveness: An independent clinical study published by JADA (Journal of the American Dental Association) is cited as supporting the device's effectiveness for relief of orofacial pain associated with temporomandibular disorders.
- Predicate Devices: Archtek OTC Grind Guard (K073446) and SleepRight adjustable night guard (K071404). The Grind Guard is stated to be identical in design and material to K073446.
In conclusion, the provided text from the 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and referencing a published clinical study for effectiveness. It does not contain the granular detail about acceptance criteria, study design parameters (like sample sizes for test/training sets, expert qualifications, or ground truth establishment methods) that would be typical for a de novo submission or a detailed clinical study report, especially for AI/algorithm-based devices.
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