(127 days)
For fabrication of temporary prostheses, such as crowns or bridges
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental device called "Mizzy Express." This document is not a study report and therefore does not contain information about acceptance criteria or performance studies of the type requested.
The letter simply states that the FDA has reviewed the premarket notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This means that the manufacturer provided sufficient evidence to show that their device is as safe and effective as a device already on the market, without needing to conduct a full clinical trial or provide detailed performance data.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for a test set.
- Number or qualifications of experts for ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document serves as a regulatory clearance, not a scientific publication detailing performance studies.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.