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THE FRIALIT-2® AUROBASE ABUTMENT IS INTENDED FOR USE IN FABRICATION OF MULTIPLE UNIT RESTORATIONS, SINGLE TOOTH ABUTMENTS LABORATORY-AND CUSTOM RESTORATIONS, CONSTRUCTED ANGLED ABUTMENTS IN THE MAXILLA AND MANDIBLE.

The FRIALIT-2® AuroBase abutment is a one part abutment with two working areas, a gold cvlinder and a plastic sleeve. The gold cylinder has as the rotational securing device a hexagon, which is the counterpart to the internal hexagon of the FRIALIT-2® implant. The plastic sleeve molded around the gold cylinder and is color-coded in order to differentiate the different diameters. The diameters of the FRIALIT-2® AuroBase abutments correspond to the FRIALIT-2® implant diameters. The following diameters are available: Ø3.8 mm. Ø4.5 mm, Ø5,5 mm and Ø6,5 mm. The FRIALIT-2® AuroBase gold cylinder is manufactured out of a commercial gold alloy. The FRIALIT-2® AuroBase plastic sleeve is manufactured out of a burnable commercial plastic.

This looks like a 510(k) premarket notification for a dental implant abutment, not a medical device that would involve a study with a test set, ground truth, or human readers as described in your request. The document describes a medical device, but it appears to be a physical component (an abutment for dental implants) rather than an AI/software-based medical device that would require the types of studies you've inquired about.

Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable to the provided 510(k) summary for the FRIALIT-2® AuroBase abutment.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (3i UCLA abutment) through:

• Description of Technological Characteristics: Comparing design features like working areas, rotational securing mechanisms (hexagon), and materials.
• Material Composition Comparison: A table showing the chemical composition of the gold cylinder for both the proposed device and the predicate device, indicating very similar percentages of Au, Pd, Pt, and Ir.
• Preclinical Testing Results: A table comparing static shear strength and dynamic fatigue strength, showing the FRIALIT-2® AuroBase met or exceeded the predicate device's performance.

This type of 510(k) submission typically relies on engineering and material testing to show that the new device is as safe and effective as a legally marketed predicate, rather than clinical trials or AI performance studies.

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