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TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.

TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.

This is a 510(k) clearance letter for preformed plastic denture teeth. This type of device does not typically involve the kind of studies or acceptance criteria you're asking about, as it is cleared based on substantial equivalence to a predicate device, not on AI/algorithm performance.

Therefore, I cannot provide information on the following:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone performance was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The document provides the following information relevant to the device:

• Device Name: TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth
• Intended Use: "TriLux, Z-tone and Acry Rock Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture."
• Regulatory Class: II
• Product Code: 76 ELM
• Regulation Number: 872.3590
• Regulation Name: Preformed Plastic Denture Tooth

The FDA's decision is based on a determination of substantial equivalence to legally marketed predicate devices, meaning it has essentially the same intended use and technological characteristics as a device already on the market, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety and effectiveness. This is a common pathway for medical device clearance and does not typically involve the rigorous performance studies required for novel AI-based diagnostic or therapeutic devices.

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