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VITA Lumex® AC is used to veneer the following:

• Full and partial veneering of zirconia
• Full and partial veneering of lithium disilicate
• Partial veneering of feldspar ceramic
• Reconstruction without a substructure
  Materials:
• Zirconia substructures (CTE approx. 10.0 to 10.5 x 10-6 K-1)
• Glass-ceramic substructures (CTE approx. 9.0 to 10.5 x 10-6 K-1)

VITA Lumex® AC is a natural low-fusing veneering ceramic system that is suitable for veneering all ceramic substructures. VITA LUMEX AC standard layering consists of the two Materials DENTINE and ENAMEL. The color-bearing DENTINE materials, which provide good coverage, offer the perfect precondition for the preparation of veneers with intensive shades. With this two-layer alternative, VITA offers an ideal solution for the reproduction of optimal shade results in case of thin walls. Additionally, the intensive shade effect of the DENTINE permits a more generous use of the ENAMEL materials, which create the desired translucency. The user is able to prepare a natural restoration with a lifelike appearance with only two layers. This product is provided non-sterile in glass jars in a powder form to be used in conjunction with the Vita low fusing liquid.

This document is a 510(k) Premarket Notification for the VITA Lumex® AC, a porcelain powder for clinical use, and not a study describing the acceptance criteria and performance of a device that meets those criteria.

Therefore, I cannot provide the requested information, which includes:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study results.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document states: "Non-Clinical Performance Testing" on page 5, indicating that "Bench test results allowed us to conclude that VITA Lumex® AC is substantially equivalent to the predicate device for its intended use." It also explicitly states "Clinical Performance Data: Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA Lumex® AC."

This filing relies on bench testing and comparison to predicates, not specific clinical performance studies with acceptance criteria as requested in your prompt.

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