Search Results

Carrara Volumia Ceramic System is indicated for the veneering of metalceramic or full ceramic restorative systems.

The Carrara Volumia Ceramic System is a dental porcelain system used for the preparation of fixed prosthodontic devices.

The provided text describes a 510(k) submission for a dental ceramic system, the Carrara Volumia Ceramic System (K070019). It states the device description, intended use, and technological characteristics. However, it does not contain any information regarding specific acceptance criteria, performance data from a study, sample sizes for test/training sets, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot fulfill your request for that specific information based on the provided text. The document primarily focuses on demonstrating substantial equivalence to a predicate device and confirming biocompatibility, rather than presenting a detailed performance study with acceptance criteria.

Information NOT Found in the Provided Text:

• Acceptance Criteria and Reported Device Performance: No specific performance metrics or acceptance criteria are listed. The submission relies on "prior use of the components... in legally marketed devices" and "performance data provided" (though not detailed here) to support safety and effectiveness.
• Sample size used for the test set and the data provenance: No information on a test set sample size or data origin.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study is detailed.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: No mention of an MRMC study.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical dental material, not an algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of available information:

• Trade/Proprietary Name: Carrara Volumia Ceramic System
• Intended Use: For the veneering of metal-ceramic or full ceramic restorative systems.
• Technological Characteristics: All components have been used in legally marketed devices and were found safe for dental use. Passed biocompatibility testing for cytotoxicity.
• Predicate Device: Carrara Interaction Ceramic System (K040635)
• Basis for Safety and Effectiveness: Prior use of components in legally marketed devices, "performance data provided" (not detailed in this summary), and biocompatibility data.

Ask a specific question about this device