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Mondial line is synthetic polymer teeth for the fabrication of full and partial dentures. The enamel and dentine layers of HK teeth are highly cross-linked and suit the rate of natural abrasion. The base of the tooth is less cross-linked to achieve optimum bonding between the tooth and the denture acrylic.

Mondial line is synthetic polymer teeth for the fabrication of full and partial dentures. The enamel and dentine layers of HK teeth are highly cross-linked and suit the rate of natural abrasion. The base of the tooth is less cross-linked to achieve optimum bonding between the tooth and the denture acrylic.

The provided text is an FDA 510(k) clearance letter for a dental device called "Mondial" (preformed plastic denture tooth). This type of document declares substantial equivalence to a predicate device and does not contain the kind of detailed study information requested in your prompt.

Therefore, I cannot provide the information you've asked for, such as:

• A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria.
• Sample size used for the test set and the data provenance: Not present.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not present.
• Adjudication method for the test set: Not present.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present, as this typically applies to AI-assisted diagnostic devices.
• If a standalone performance (algorithm only) was done: Not present.
• The type of ground truth used: Not present.
• The sample size for the training set: Not present.
• How the ground truth for the training set was established: Not present.

This letter solely confirms that the "Mondial" denture teeth are substantially equivalent to previously marketed devices and are cleared for marketing based on their intended use in the fabrication of full and partial dentures. The "study" referenced in 510(k) submissions typically refers to non-clinical tests (e.g., material properties, dimensional stability) or comparisons to predicate devices, rather than clinical efficacy studies with human subjects that would generate the data you're asking about for AI/diagnostic devices.

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