(68 days)
MOUTHGUARD AND ALIGNER MATERIALS are indicated for the fabrication of orthodontic and dental appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges.
MOUTHGUARD AND ALIGNER MATERIALS are plastic, resin, or laminate materials that are sold for the purpose of making various dental and/or orthodontic appliances such as aligners, bite planes, mouthguards, nightguards, snoring appliances, splints, retainers, repositioners, and temporary bridges. Each material is indicated for the fabrication of orthodontic and dental appliances. Each material is recommended for the construction of specific Class I and II dental devices and appliances. In most cases, the sheets are thermoformed and trimmed to create custom devices or appliances.
The provided text is a 510(k) summary for "MOUTHGUARD AND ALIGNER MATERIALS." This document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the intended use and technological characteristics of the materials.
It does NOT contain information about specific acceptance criteria related to device performance metrics (e.g., sensitivity, specificity, accuracy), nor does it describe any study involving human readers, ground truth establishment, or sample sizes for testing or training sets.
The summary states: "We believe that the prior use of the components in legally marketed devices and the data provided support the safety and effectiveness of MOUTHGUARD AND ALIGNER MATERIALS for the indicated uses." This indicates that the safety and effectiveness were supported by relying on the known properties of the materials and their previous use in other legally marketed devices, rather than a clinical performance study of the materials themselves against a set of predefined acceptance criteria in the manner requested.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, or comparative effectiveness studies based on the provided text.
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