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CLEAFIL NEW BOND is indicated for the following applications:

1. A dentin and enamel bonding system for composite resin restoration
2. A dentin and enamel bonding system for amalgam restoration

CLEARFIL NEW BOND is classified into Resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling. Normally composite resins and amalgams are used as filling material for this purpose.

The provided text is a 510(k) summary for a dental adhesive system called CLEARFIL NEW BOND. It describes the device, its intended use, and states that it is essentially the same as a previously cleared predicate device (K943167).

However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a submission to the FDA seeking clearance based on substantial equivalence to an existing device, not a report of performance testing against specific criteria.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample size used for the test set and the data provenance: Not present, as no performance test is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not present.
6. If a standalone performance study was done: Not present.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present, as this is not an AI/algorithm-based device and no training set is mentioned.
9. How the ground truth for the training set was established: Not present.

The document focuses on:

• Identifying the submitter and device.
• Classifying the device.
• Stating its equivalence to a predicate device (K943167).
• Describing its intended use (dental bonding agent).
• Asserting that its technological characteristics, chemical ingredients, and safety are "completely the same" as the predicate device.

The FDA's letter (pages 2-3) confirms their review of the submission and their determination of "substantial equivalence" to legally marketed predicate devices. This substantial equivalence determination is the basis for clearance, rather than a new performance study to meet specific acceptance criteria for a novel device.

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