(165 days)
XT stain/glaze are glazing porcelains used to color staining and glazing of the surfaces of dental ceramic restorations,such as glass ceramic or zirconia-based ceramic.
XT stain/glaze includes glaze powder,glaze liquid,stain glaze,glaze spray. Glaze powder is composed primarily of SiO2,with components of B2O3,Al2O3, Na2O,K2O,Li2O, other oxides,and color additives. Glaze liquid is composed of deionized water and organic solvents. Stain glaze is mixed with glaze powder and glaze liquid,which can help dental professionals save the mixing process.It is in the form of a paste and applied to dental ceramic restoration surfaces by brushing.Glaze powder has 17 colors; therefore, glaze paste also has 17 colors. Glaze spray consists of glaze powder(Transparent-Glaze),organic solvent,deionized water, and Non-CFC propellant.It is supplied to dental professionals in the form of an aerosol can and applied to dental ceramic restoration surfaces by spraying. Glaze spray and stain glaze require the firing of the dental ceramic restorations after application of the glaze. During the firing process, the organic solvent and deionized water burn without being included in the dental ceramic restorations. Therefore, the final chemical composition of the dental ceramic restorations is the glaze powder.
The provided document is a 510(k) Premarket Notification from the FDA for a dental product called "XT Stain/Glaze". This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not typically for showing an AI medical device meets specific performance criteria through a clinical study.
Therefore, the document does not contain the information requested regarding acceptance criteria for an AI-powered device, the specifics of a study proving such criteria are met, sample sizes for test/training sets, expert qualifications, or details of MRMC studies.
The document focuses on:
- Device Description: XT Stain/Glaze is a dental material (porcelain powder, liquid, paste, spray) used for coloring, staining, and glazing dental ceramic restorations.
- Substantial Equivalence: Comparing the subject device (XT Stain/Glaze) to predicate devices (K181167 and K202629) based on indications for use, form, application, composition, sterility, type of dental ceramic, packaging, shelf life, physical properties, and biocompatibility.
- Non-Clinical Performance Data: Mentioning tests conducted like heavy metal testing (USP 43-NF 38:2020), other performance testing (ISO 6872), biocompatibility assessment (ISO 10993 series), transport and package testing (ISTA 3A), and shelf life evaluation (ASTM F1980).
- No Clinical Performance Data: Explicitly states, "No data from human clinical studies has been included to support the substantial equivalence of the subject device, XT stain/glaze."
In summary, this document is a regulatory submission for a dental material, not an AI medical device. Thus, it does not provide the details required to answer your specific questions regarding AI device acceptance criteria and study data.
§ 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.