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Renamel Flowable Composite is used for Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers.

Renamel Flowable Composite is a system consisting of light-cured flowable composite restorative dental materials.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance for the "Renamel Flowable Composite" device.

The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices. It covers:

• Device Name: Renamel Flowable Composite
• Manufacturer: Cosmedent, Incorporated
• Regulatory Class: II
• Product Code: EBD
• Date of Clearance: February 10, 1998
• Indications for Use: Class V restorations, small occlusal restorations, to seal margins, to repair pitted areas in restorations, as a pit and fissure sealant, to repair marginal defects, for bonding of fibrous splints and for direct resin veneers.
• Device Description: A system consisting of light-cured flowable composite restorative dental materials. It also mentions a "confidential chemical analysis... in Appendix C," which is not provided.

However, the letter does not include:

• Specific acceptance criteria for performance.
• Details of any study (like sample sizes, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone performance).
• Any performance metrics or results.

For a 510(k) submission, the primary aim is to demonstrate substantial equivalence to a predicate device, not necessarily to conduct de novo clinical trials with strict performance criteria and detailed study designs as might be found in a PMA (Premarket Approval) application or a more recent clinical study report. The FDA concluded that the device is substantially equivalent, implying that its performance characteristics are comparable to existing, legally marketed devices.

Therefore, I cannot populate the table or answer the specific questions about study design, sample sizes, expert involvement, or reported performance.

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