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Neodent prosthetic abutments are indicated to be used on Neodent implants to provide support for prosthetic structures for up to 6 months. They can be used in single- or two-stage procedures and they are intended to be placed out of occlusion.

The subject device is a temporary abutment composed of PEEK with a titanium alloy fixation screw. The subject device is compatible with Neodent zirconia implant bodies with Zilock connection platform (K201491).

• Intended for single use;
• Provided sterile via Ethylene Oxide;
• The subject devices are manufactured of PEEK (high performance polymer – specific for dental use) and are provided along with a screw manufactured of titanium alloy according to ASTM F136 standard;
• . ZiLock prosthetic interface with internal indexer;
• . Cylindrical format with a passing hole to fixate the screw.

I apologize, but the provided text is an FDA 510(k) Pre-market Notification letter and a 510(k) Summary for a dental implant system. It primarily focuses on demonstrating substantial equivalence of a new device (Neodent Implant System - Zirconia Implant System) to existing predicate devices.

This document does NOT contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

The document details:

• The device's trade name, regulation number, and product code.
• Indications for Use.
• Comparison of technological characteristics between the subject device and predicate devices (e.g., intended use, design, materials, sterilization).
• Bench testing (biocompatibility, MRI compatibility) and sterilization validation, largely leveraged from predicate devices.

It does not describe an AI/ML-based device, nor does it provide the type of study details requested (e.g., expert ground truth, sample sizes for AI model testing/training, MRMC studies, standalone performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text, as this information is not present.

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