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• Impression material in a dual phase impression technique
• Precise duplication of models
• Capturing multiple unit impressions
• All impression techniques where the operator needs a heavy or low viscosity material

Vonflex™ Heavy/ Vonflex™ Light as the additional polymerization silicone type, is a rubber impression material that makes oral tissue shape precisely. And it is very easy to handle and has low deformation, helping to make precise impression taking.

The provided text describes a 510(k) summary for a dental impression material named Vonflex™ Heavy/ Vonflex™ Light. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis.

Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and statistical measures from a study proving device performance is not explicitly available in this document.

Here's an analysis based on the information provided, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria for performance are not explicitly stated as quantitative metrics with pass/fail thresholds in this summary. Instead, the summary asserts "similar characteristics" to the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified.
• Data Provenance: Not specified. The submission is from Vericom Co., Ltd. in the Republic of Korea. It implies that any testing would have been conducted by the manufacturer or a contracted lab. The document does not indicate if the data is retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided as the submission focuses on demonstrating equivalence to a predicate device through non-clinical characteristics rather than a study requiring expert-established ground truth.

4. Adjudication method for the test set

• This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• This device (dental impression material) is a physical, passive material and does not involve AI or human readers in the context described for an MRMC study. Therefore, an MRMC study was not done.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This device does not involve an algorithm. Therefore, a standalone algorithm performance study was not done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The concept of "ground truth" as typically applied to diagnostic AI/imaging devices is not directly applicable here. The evaluation of this device would involve physical and chemical property testing (e.g., rheology, setting time, dimensional stability, biocompatibility) rather than diagnostic accuracy against a ground truth diagnosis.

8. The sample size for the training set

• This device does not involve a "training set" in the context of an algorithm or statistical model. The term is not applicable.

9. How the ground truth for the training set was established

• As in point 8, the concept of a "training set" and associated ground truth is not applicable to this type of medical device submission.

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