Search Results

SII CAST ( RD-0118 ) is a predominently base metal alloy under ADA and er Type-March (2000) and arters for Dental alloy, It is designed for Type-III hard Crown and Bridge alloy. SILCAST with platinum-white color provides quality restorations and it polishes to a high lusture. This bace in and short span bridges.

SILCAST (Code Name RD-0118)

Unfortunately, the provided document is a 510(k) clearance letter from the FDA for a dental alloy called SILCAST. This type of document primarily confirms that a medical device is substantially equivalent to a legally marketed predicate device and grants permission to market it.

It does not contain the detailed information you've requested regarding acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment. These specifics are typically found in study reports, clinical trial documentation, or pre-market submission summaries, which are not part of this FDA clearance letter.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not specify any performance criteria or report on device performance against such criteria.
2. Sample size used for the test set and the data provenance: No information about a test set or its sample size is present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not discussed.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No mention of such a study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a dental alloy, not an algorithm.
7. The type of ground truth used: Not applicable as no study is detailed.
8. The sample size for the training set: Not applicable as the device is a material, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.

The letter simply states that the "device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices". The enclosure details the device's indications for use: "SILCAST (RD-0118) is a predominently base metal alloy under ADA and is included for Crown and Bridge alloy. It is designed for Type-III hard Crown and Bridge alloy. SILCAST with platinum-white color provides quality restorations and it polishes to a high lusture. This base in and short span bridges."

Ask a specific question about this device