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CLEARFIL SILANE KIT is indicated for the following applications:

1. Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light curing composite.
2. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin.

CLEARFIL SILANE KIT is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to paint on the surface of a porcelain, hybrid ceramics and composite resin.
This device is a kit product that consists of three components, a primer, an etching agent and a silane coupling agent.

The provided document is a 510(k) premarket notification for a medical device called "CLEARFIL SILANE KIT." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive de novo clinical study data with detailed acceptance criteria and performance tables for the new device.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment is not available within this document.

The document primarily focuses on:

• Device Identification: Naming the device, manufacturer, and contact information.
• Classification: Identifying the regulatory classification and product code.
• Predicate Devices: Listing previously cleared devices to which the new device claims substantial equivalence.
• Description: Briefly describing the device as a kit of three components (primer, etching agent, silane coupling agent) that are also found in the predicate devices.
• Intended Use: Specifying the applications for the device, which are identical to those of a predicate device (CLEARFIL SE BOND).
• Technological Characteristics and Safety: Stating that the device is substantially equivalent to predicate devices in these aspects because its components are the same and their combined use is described in the predicate's instructions.
• FDA Clearance Letter: Confirming that the FDA has reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices, thus allowing it to be marketed.

In summary, this 510(k) submission relies on the established safety and effectiveness of its predicate devices, rather than presenting a new clinical study with specific acceptance criteria and performance metrics for the CLEARFIL SILANE KIT itself.

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