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The Strauman® PURE Ceramic Implant is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw.

The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

The Straumann® PURE Ceramic Implants (Tissue Level Monotype and Tissue Level two-piece design) are part of the Straumann® Dental Implant System, which is an integrated system of endosseous dental implants with corresponding instruments and prosthetic parts. The Straumann® PURE Ceramic Implants are solid screw implants with a bone anchorage surface that is large-grit sandblasted and acid-etched (ZLA® surface). The implants have a 1.8 mm high machined transmucosal neck. The Straumann® PURE Ceramic Implant has a two -piece design with internal connection based on features of the Straumann® Tissue Level Standard Plus and Straumann® Bone Level Implants. The Straumann® PURE Ceramic Implant Monotype features a monotype design where the ceramic abutment for final restoration is already built in.

This document, a 510(k) summary for the Straumann® PURE Ceramic Implants, does not contain information about an AI/ML device or a study proving its performance against acceptance criteria in the way a typical AI/ML medical device submission would.

The document describes a dental implant (a physical medical device) and its equivalence to previously cleared predicates. The nonclinical testing mentioned (dynamic fatigue, biological assessment, sterilization validation, packaging stability, MRI compatibility, surface features) are standard tests for physical implants to ensure their safety and effectiveness.

Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an AI/ML device from this document. The concepts of "test set," "ground truth experts," "adjudication," "MRMC study," "standalone performance," "training set," and "how ground truth for training set was established" are not applicable to the non-AI/ML device described in this 510(k) summary.

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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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