Search Results

TopCEM Ceramic Primer Ceramic Coupling Agent serves as priming agent and is used to create a durable adhesion between luting composites and glass/oxide ceramic, metal, composite and fiberreinforced composite restorations.

TopCEM Ceramic Primer Ceramic Coupling Agent is common oral cementation repair auxiliary materials. In the process of using the product, TopCEM Ceramic Primer Ceramic Coupling Agent is placed between the prosthesis and resin adhesives, which can form the bonding layer of tooth tissue - light cure dental adhesive layer - resin cement layer - ceramic coupling agent - prosthesis, so as to achieve better bonding effect. TopCEM Ceramic Primer Ceramic Coupling Agent does not have direct contact with tooth tissue during use. TopCEM Ceramic Primer Ceramic Coupling Agent is mainly composed of silane coupling agent, acid acrylate and volatile organic solvent.

The provided document is a 510(k) Premarket Notification from the FDA for a dental bonding agent. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document does not contain any information about a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy, as would be expected for an AI/ML medical device. The device described is a "Ceramic Primer Ceramic Coupling Agent," which is a chemical product used in dentistry, not an AI/ML-driven diagnostic or prognostic device.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy).
• Sample sizes for test sets or data provenance.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical testing of physical properties and biocompatibility for a chemical product. It states:

• "Summary of Non-clinical testing": "The physical properties of the subject device, including Appearance, Solid Content, Bond Strength (MPa), Whether there are traces left on the glass panel surface, Packing Amount Tolerance and Detection of Infrared Characteristic Peaks, were determined and tested according to Internal standard SOP of the company, and the test results demonstrated the qualification and substantial equivalence when compared to the predicate device."
• "Summary of Clinical testing": "Clinical test is not applicable."

This indicates that the "acceptance criteria" and "proof" in this context relate to chemical and physical properties, and biocompatibility, as evaluated through internal SOPs and comparison to a predicate device, rather than the performance metrics typically associated with AI/ML diagnostic tools.

Ask a specific question about this device