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The Thommen SPI® EASY Temporary Cap is intended to be used in conjunction with SPI® System dental implants, which provide support for crowns, bridges or overdentures in the maxillary and/or mandibular arch. It is used to protect the coronal surface of the abutment and to serve as a base for a temporary restoration.

The Thommen SPI® EASY Temporary Cap is an endosseous dental implant component used for maintaining the gingival contour and as a base for a fabrication of a temporary restoration. It also serves to protect the coronal aspect of the abutment from damage and the patient's tongue from injury during the time the final restoration is being fabricated. The Temporary Cap will be offered in sizes to fit all SPI® EASY abutments and may be used with all SPI® System dental implants.

The provided text is a 510(k) Summary for a medical device called "SPI® Easy Temporary Cap". This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It does NOT contain information about acceptance criteria, a specific study proving the device meets criteria, or any details related to AI/algorithm performance, ground truth establishment, sample sizes for training/testing, or expert involvement in a study.

The document primarily focuses on:

• Administrative information about the manufacturer and device.
• Device classification and associated regulations.
• Predicate device information.
• Intended use and device description.
• A statement of equivalence to marketed products based on intended use, operating principle, basic design, and packaging.
• The FDA's letter of substantial equivalence determination.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, or AI performance based on the provided text. The document indicates that "No performance standards applicable to endosseous dental implant abutments have [been applied to the SPI® EASY Temporary Cap] and the material it is made complies with ISO 10993-1." This suggests that the "acceptance criteria" primarily relate to material biocompatibility and design similarity to predicate devices, rather than a quantifiable performance outcome with specific metrics.

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