Search Results

Bonding resin to metal, zirconia or alumina restorations

• Application of opaque resin to frameworks
• Cementation of inlays, crowns and bridges with resin cement
• Bonding of denture base resin to metal base, clasp or attachment
• Bonding resin to orthodontic appliances
• Intraoral and extraoral repair of fractured restorations

Not Found

This document is an FDA 510(k) clearance letter for a dental bonding agent, SHOFU MZ Primer Plus. It declares the device substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria or a study proving device performance against acceptance criteria for an AI/CAD/software device. This is a clearance for a chemical dental product, not a software or AI-driven device.

Therefore, I cannot provide the requested information as it is not present in the provided text.

Ask a specific question about this device

• [1] Surface treatment of prosthetic restorations made of ceramic, hybrid ceramics, composite resin or metal
• [2] Intraoral repairs of fractured restorations made of ceramics, hybrid ceramics, composite resin or metal

Not Found

The provided text is a US FDA 510(k) clearance letter for the device "CLEARFIL CERAMIC PRIMER PLUS". This document confirms that the device has been found substantially equivalent to predicate devices. However, this type of document does not contain the information requested in your bullet points regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The FDA 510(k) summary (which is a separate document typically published alongside the clearance letter) or the submission itself would contain details about the performance data. Without access to those documents, I cannot provide the requested information.

The clearance letter focuses on:

• Confirming substantial equivalence.
• Listing the device name, regulation number, and product code.
• Outlining regulatory compliance responsibilities for the manufacturer.
• Specifying the "Indications for Use" for the device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

Primer Plus is a universal restoration primer.

The principle uses of the Primer Plus are:

• 1. Indirect restorations (such as composite, endodontic posts, metal/metal alloys, porcelain, zirconia, alumina, ceramics, and hybrid ceramics)
• 2. Intraoral repairs of fractured crowns and bridges (such as metals/metal alloys, porcelain, zirconia, alumina, ceramics, hybrid ceramics, or composite resin)

The Primer Plus is a universal restoration primer.

The provided text is for a 510(k) summary for a dental product called "Primer Plus Universal Restoration Primer" by Bisco, Inc. This document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The document is a regulatory submission for a dental material, not an AI/ML diagnostic or assistive device. Therefore, the concepts of "acceptance criteria," "test set," "ground truth," "MRMC study," "standalone performance," and "training set" as they relate to AI/ML device performance are not applicable to this submission.

The document discusses:

• Description of the Device: "Primer Plus is a universal restoration primer."
• Intended Use: Indirect restorations and intraoral repairs of fractured crowns and bridges.
• Substantial Equivalence: The device is being cleared based on its substantial equivalence to legally marketed predicate devices (Clearfil Ceramic Primer (K061906) and One Step Plus (K011159)) in terms of intended use, indications for use, chemical composition, and physical properties.
• Biocompatibility: An evaluation of biocompatibility was conducted to determine safety.

In a traditional medical device 510(k) submission like this, "acceptance criteria" would refer to the performance benchmarks demonstrated by the predicate device that the new device must meet or exceed to prove substantial equivalence. The "study" mentioned would typically involve material property testing (e.g., bond strength, mechanical properties, biocompatibility) to show that the new device performs comparably to the predicates.

However, none of the specific AI/ML-related questions you asked can be answered from this document.

Ask a specific question about this device