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AMALCAP PLUS is to be used as a filling material for restoring function to teeth which have lost portions to caries:

Direct, fixed restorations, placed by the dentist after removal of carious tissue.

Single surface cavities such as Class I

Two surface cavities such as MO, DO, FO, LO

Three surface cavities such as MOD, FOD.

Pinned onlays and half crowns.

Core build-ups for cast half and full crowns.

For use only by dental professional such as DDS or DMD. Not for use by general public or OTC.

Not Found

This looks like a 510(k) clearance letter for a medical device (AMALCAP PLUS) from the FDA in 1998. The document primarily focuses on regulatory approval and general information rather than a detailed study report or acceptance criteria for technical performance.

Therefore, the requested information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided text.

The document only states the "Indications for Use" for AMALCAP PLUS, which describes its intended purpose as a filling material for restoring teeth. It does not contain any details about the studies or data used to demonstrate its safety and effectiveness.

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