(133 days)
The Mouth Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and reduce the noise associated with bruxing or grinding.
The Mouth Guard is an over-the-counter (OTC) device to be used by lay people for protection against the effects of nighttime teeth grinding. The guard is constructed of a thermoplastic ethylene-vinyl acetate copolymer and is fitted by molding the bite pads to the user's teeth after the guard has been heated via submersion in boiled water. The fully occlusive guard is worn on the upper teeth, maintaining separation between the upper and lower teeth, thereby reducing the noise and damage associated with teeth grinding.
This document is a 510(k) summary for a Mouth Guard device, not a typical diagnostic AI or image analysis device that would be evaluated with specific metrics like sensitivity, specificity, or improvement with AI assistance. Therefore, many of the requested points regarding acceptance criteria and study details (e.g., ground truth, MRMC study, sample size for test/training sets, number of experts, adjudication methods) are not applicable to the information provided in this document.
The Mouth Guard is a physical device, and its acceptance criteria and performance are based on bench testing (non-clinical) rather than clinical studies or the analysis of medical images by AI.
Here's an analysis of the provided text based on the questions, highlighting what is (and isn't) present:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with specific numerical thresholds and corresponding performance values for the Mouth Guard. Instead, it states that "Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling."
It lists the types of performance tests conducted:
- Hardness
- Tear strength
- Impact and rebound
- Water absorption
- Impression test
- Separation test
- Stability test
It also lists biocompatibility tests:
- Cytotoxicity
- Oral Mucosa Irritation
- Skin Sensitization
- Acute systemic toxicity
- Sub chronic systemic toxicity
- Genotoxicity
The reported performance is a qualitative statement: "The non-clinical testing of Mouth Guard demonstrates the device's performance in providing including hardness, tear strength, impact and rebound, and water absorption, which supports its substantial equivalence to the predicate device." And for biocompatibility: "The results of the testing met the requirements of the study protocols and the material is considered non-toxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence to the predicate."
2. Sample sized 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 because the submission did not include a clinical study or a "test set" in the context of AI/ML evaluation. The testing was non-clinical (bench testing) and biocompatibility testing. No mention of data provenance like country of origin or retrospective/prospective nature is made for these types of tests in this document.
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. As this is a physical device measured through bench tests and biocompatibility, there are no "experts" establishing ground truth in the sense of medical image interpretation. Performance is measured against physical standards and parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or adjudication process described for the evaluation of this physical device.
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 is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be established physical standards, material specifications, and validated test methods for properties like hardness, tear strength, and biocompatibility. It's not "expert consensus" or pathology outcomes as would be seen in diagnostic claim evaluations.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this kind of physical device submission.
9. How the ground truth for the training set was established
Not applicable. There is no concept of a "training set" for this kind of physical device submission.
In summary, the provided document is a 510(k) clearance letter for a non-AI/ML medical device (a mouth guard). The substantial equivalence determination is based on a comparison to predicate devices and non-clinical bench testing. The nature of the device and the submission means that most of the questions relating to AI/ML device evaluation criteria are not applicable.
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