(175 days)
Glass Ceramics are indicated for fabricating all-ceramic restorations such as veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
Glass Ceramics contains glass ceramic blocks for dental use. The main ingredients of the product include Silica: 55%~65%: Lithium oxide: 12%~25%: Alumina: 2%~12%; Potassium oxide: 2%~14%; Other oxides: 0%~10%. Through the digital scanning of teeth or tooth mold, 3D data of tooth mold can be obtained. According to this data, CAD design can be carried out to design porcelain block processing model. Then, a CNC machine tool was used to manufacture the all-porcelain denture crown by CAM according to the porcelain block processing model. After air sintering or vacuum sintering, the all-porcelain denture was made to achieve the strength and aesthetic effect required by clinical use.
The provided text is a 510(k) Premarket Notification from the FDA regarding a dental device called "Glass Ceramics." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria related to an AI/Software as a Medical Device (SaMD) product.
Therefore, the requested information for an acceptance criteria table and a study proving a device meets these criteria (especially concerning AI/ML performance metrics like sensitivity, specificity, AUC, or reader improvement with AI assistance, sample sizes for AI training/test sets, expert ground truth establishment, etc.) cannot be extracted from this document, as it is about a material (dental glass ceramics) and not an AI/SaMD product.
The document discusses:
- Physical and Chemical Properties Tests: These are bench tests against standards like ISO 6872:2015 for properties like flexural strength, chemical solubility, coefficient of thermal expansion, and glass transition temperature.
- Biocompatibility Tests: These tests follow ISO 10993 standards for cytotoxicity, sensitization, irritation, systemic toxicity, subchronic toxicity, and genotoxicity.
- No Clinical Performance Data: The document explicitly states "Clinical performance testing has not been performed for the subject device."
- No mention of AI/ML: There is no indication that this device incorporates AI or machine learning.
Summary of why the requested information cannot be provided:
The input document describes a physical medical device (dental glass ceramics) and its FDA 510(k) clearance process, which relies on demonstrating substantial equivalence to an existing predicate device based on physical, chemical, and biocompatibility properties. It does not involve AI or software performance metrics, clinical studies with human readers, or ground truth establishment in the context of diagnostic or interpretive tasks.
To answer your prompt, I would need a document related to an AI/SaMD product, not a material science product.
§ 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.