(200 days)
- Protection of teeth and restorations from the forces of bruxism.
- For the prevention of TMJ syndrome through reduction of trigeminally innervated muscular activity.
The Myohealth Clenching Inhibitor disrupts the activity of the perieranial musculature by providing contact between the ental contact provided by this intraoral device modifies the rearward tectir. The mounted contraction of the pericranial musculature and the associated bruxism and temporal mandibular disorders.
The MCI is an anterior device custom fabricated for each patient. The Myohealth The MCI Is an amerior dories do for treating conditions diagnosed by medical professionals.
The MCI Clenching Inhibitor is designed to span 6 teeth, from upper cuspid to cuspid. The larger size of the MCI greatly reduces the risk of inhalation or swallowing this appliance. The MCI Clenching Inhibitor has a thermoplastic lining. This lining ensures excellent long term retention.
This FDA 510(k) summary for the MCI Clenching Inhibitor does not contain the detailed information requested regarding acceptance criteria, device performance studies, and ground truth establishment.
A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than providing extensive de novo clinical trial data with specific performance metrics and ground truth analysis as would be expected for a novel high-risk device or a more rigorous clinical study.
Therefore, most of the requested information cannot be extracted directly from the provided text. I will explain what can be inferred or what is explicitly missing.
Here's a breakdown of the requested information, indicating what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given 510(k) summary. A 510(k) typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than defining and proving specific acceptance criteria for performance through a standalone study with quantitative results. The comparison provided (see section 2 of the input) is for attributes of the device (indications, materials, method of action), not performance metrics against acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document does not describe a specific clinical study with a test set of data.
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)
This information is not provided. As no specific test set or study is described, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided. The device described is a physical occlusal stent, not an AI or imaging device that would typically involve a multi-reader multi-case study or human-in-the-loop AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided. The device is a custom-fabricated physical device, not an AI model that would have a training set.
9. How the ground truth for the training set was established
This information is not provided.
Summary of what is present and relevant to the "study" in a 510(k) context:
The "study" in a 510(k) submission, particularly for a device like this, is primarily a comparative analysis of attributes to a predicate device, aiming to demonstrate substantial equivalence.
- Predicate Device: NTI Clenching Suppression System (K981546)
- Comparison Attributes (Table from input section 2):
- Indications for use: Both protect teeth from bruxism forces and address TMJ/TMD related to clenching. The MCI device broadens the TMJ indication slightly to "Recovery from temporal mandibular disease (TMD) in which bruxism is a contributing factor" and "prevention of TMJ syndrome through reduction of trigeminally innervated muscular activity."
- Method of manufacture: Both custom fabricated.
- Single patient, intraoral device: Both yes.
- Material: Both Thermoplastic acrylic.
- Method of action/intended use: Both are anterior bite stops that inhibit masticatory musculature.
- Risk of material exposure: Both none.
The "proof" presented in this 510(k) summary for the MCI Clenching Inhibitor meeting acceptance criteria (implicitly, the criteria for substantial equivalence) rests on this direct comparison of features and intended use with the legally marketed predicate device (NTI Clenching Suppression System, K981546). The FDA's issuance of the 510(k) clearance letter (input section 3) indicates their agreement that substantial equivalence was demonstrated based on this comparison, allowing the device to be marketed.
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