(196 days)
rainbow Paste Stain SE is indicated for use as a veneering material for fixed prosthesis in crowns and bridges. This device is used in prosthetic dentistry by forming a porcelain veneer on to a ceramic substructure.
rainbow™ Paste Stain SE is a dental veneering material in paste form used for color staining and glazing of the surfaces of restorations such as porcelain-fused zirconia, full-contoured zirconia, or lithium disilicate. The intended use of general porcelain is to make artificial teeth (dental prosthesis) more similar with natural teeth. The subject device is pre-mixed paste form, which can help dental technicians exclude mixing process of porcelain powder and liquid.
Given the provided text, there is no information about a study involving AI, human readers, or a medical device that diagnoses or analyzes conditions. The document is a 510(k) summary for a dental product called "rainbow Paste Stain SE," which is a veneering material for fixed prosthetics. The performance data presented refers to the physical and chemical properties of the material itself, not the performance of an AI algorithm or human readers.
Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets them in the context of AI assistance, human reader improvement, or ground truth establishment for a diagnostic device.
The provided document discusses:
- Device Name: rainbow™ Paste Stain SE
- Intended Use: As a veneering material for fixed prosthesis in crowns and bridges.
- Acceptance Criteria for the material's properties: These are physical and chemical metrics like flexural strength, chemical solubility, appearance, and biocompatibility.
- Performance Data: Results of tests against these material-specific criteria.
There is no mention of:
- AI or software.
- Diagnostic capabilities.
- Human-in-the-loop performance studies.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Ground truth established by experts, pathology, or outcomes data in a diagnostic context.
- Training or test sets in the machine learning sense.
The acceptance criteria and performance data provided in the document relate to the physical and chemical properties of the dental paste itself, demonstrating its suitability as a dental material compared to a predicate device.
If you have a different document that details an AI medical device study, please provide that.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.