(65 days)
Jensen Zirconia consists of pressed Zirconia – Yttrium blocks intended for milling of full contour crowns, crown and bridge substructures and implant super structures to produce prostheses for replacement of missing / damaged dentition.
Jensen Zirconia ceramic is pressed and sintered blocks of Yttria stabilized Zirconia used to make copings and full contour crowns for dental restorations. Restorations are fabricated according to a dental impression scanned into a computing device. By CAD/CAM technology, the blocks are machined in an automated milling machine. After machining, the units are heat treated. Full contour units may then be stained and glazed with available finishing materials. Coping units can be completed by conventional veneering with available Zr compatible dental porcelains and stained and glazed.
Based on the provided documents for Jensen Zirconia (K112806), it is not possible to describe acceptance criteria and a study that proves the device meets them in the way requested. The document is a 510(k) summary for a dental material (zirconia blocks) and focuses on demonstrating substantial equivalence to a predicate device, not on the performance of an AI-powered diagnostic device.
The questions asked pertain to the validation of an AI device (e.g., accuracy, sensitivity, specificity, human reader improvement with AI assistance, ground truth establishment, training and test sets). The Jensen Zirconia device is a physical dental material used for fabricating crowns and bridges.
Therefore, I cannot provide the requested information because:
- No AI component: The device (Jensen Zirconia) is a material, not an AI or diagnostic device.
- No performance metrics for diagnostics: The document discusses mechanical properties and chemical qualities for substantial equivalence, not diagnostic accuracy metrics (like sensitivity, specificity, AUC).
- No clinical study for diagnostic performance: The 510(k) summary refers to "data has been presented to demonstrate that the respective mechanical properties, chemical qualities, and the indications for use make Jensen Zirconia substantially equivalent to the predicate device LAVA Frame." This is a comparison of material properties, not a clinical study on diagnostic accuracy or AI performance.
- No elements for AI validation: There is no mention of test sets, training sets, ground truth establishment by experts, adjudication methods, or MRMC studies, as these are concepts relevant to AI validation, not material equivalence.
In summary, the provided text describes a 510(k) submission for a dental material, not an AI-powered medical device. The questions are specifically tailored for AI/diagnostic device validation, which is out of scope for this document.
§ 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.