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The ZERAMEX® XT Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The ZERAMEX® XT Dental Implant System can be used for single or multiple unit restorations. The ZERAMEX® XT Dental Implants are indicated for delayed loading. The ZERAMEX® dental implants are specially indicated for patients with metal allergies/intolerances and chronic illnesses due to metal allergies/ intolerances.

The NobelPearl Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore aesthetics and chewing function. The NobelPearl Dental Implant System can be used for single or multiple unit restorations. NobelPearl Dental Implant System are intended for delayed loading. NobelPearl Dental Implant System are specially indicated for patients with metal allergies/intolerances and chronic illness due to metal allergies/intolerances.

The Zeramex® XT Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The Zeramex® XT implants may be restored with screw retained Zeramex® XT abutments. The Zeramex® XT implants are placed using the Zeramex® XT surgical tools.

The NobelPearl Dental Implant System is an endosseous dental implant/abutment system including various sizes of endosseous two piece dental implants, abutments, and accessories. The NobelPearl Dental Implant System may be restored with screw retained NobelPearl abutments. The NobelPearl Dental Implant System are placed using the NobelPearl surgical tools.

The implants, abutments, and surgical tools for the Zeramex® XT and NobelPearl Dental Implant Systems are exactly the same; two trade names are being used for marketing purposes.

The implants, produced from aluminum toughened zirconia (conforming to ISO 6474-1:2010 Implants for Surgery - Ceramic Materials and ISO 6872:2015 Dentistry - Ceramic Materials), are provided sterile in two (2) diameters (0 4.2 mm (RB), and 5.5 mm (WB)) and three (3) lengths (8 mm, 10 mm, and 12 mm). The Ø 4.2 mm implant is also provided in 14 mm. The implants are designed with a "bolt-in tube" internal connection which provide anti-rotational features.

Straight and angular (15°) screw retained abutments, provided non-sterile in two sizes (RB; Ø 5.0 mm and SB, Ø 6.0 mm), are compatible for use with the system implants. The straight and angular abutments are made from the same zirconium materials as the system implants.

The screw retained abutments fit within four (4) retention elements and are affixed to the implant with a carbon fiber reinforced PEEK-Optima™ Ultra VICARBO® screw (straight) which fits the internal thread of the implant and provides a secure, screw retained ceramic on ceramic connection.

Healing caps and gingivaformers are also provided in the system. These components, provided in two sizes, are manufactured from PEEK and are connected to the implant using a screw. Provisional restoration components may be used to support temporary crowns after the healing period. The provisional restorations and the provisional restoration screws are made of carbon fiber reinforced PEEK.

This document describes a 510(k) premarket notification for the Zeramex® XT Dental Implant System and NobelPearl Dental Implant System. It presents a comparison to predicate devices to demonstrate substantial equivalence, but it does not describe a study that uses acceptance criteria in the context of a diagnostic or AI device and its performance.

The document primarily focuses on demonstrating substantial equivalence for the dental implant systems based on:

• Indications for Use
• Materials of Construction (aluminum toughened zirconia, PEEK)
• Design (two-piece, implant lengths, implant diameters, abutment angulation, screw retained implant/abutment connection, carbon-fiber reinforced PEEK screws)
• Sterilization Methods
• Performance data through fatigue testing and leveraging prior predicate device testing (shelf-life, packaging, transport, cleaning and sterilization validation, biocompatibility, bacterial endotoxin testing, surface composition analysis, surface roughness and contact angle testing).

Therefore, I cannot extract the requested information regarding acceptance criteria and device performance in the context of a diagnostic or AI study as it is not present in the provided text.

The closest relevant information is that fatigue testing was conducted on the subject devices against ISO 14801 standards, and "verification activities... were conducted to written protocols with predefined acceptance criteria." However, the specific acceptance criteria for the fatigue testing or the results are not explicitly detailed in a format that allows for the creation of Table 1. No information regarding test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established is provided, as these are typically associated with diagnostic or AI device evaluations.

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