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The Cowell Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is not intended for immediate loading.

The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

The Cowell Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.

The provided text describes a 510(k) summary for the Cowell Implant System, a dental implant. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from the provided text.

The document states:

• "The Cowell Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics."
• "The Cowell Implant systems are similar in fundamental scientific technology to the predicate devices (K090825, K053353) in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutment."
• "concludes that the ball abutment is safe and effective and substantially equivalent to predicate devices as described herein."

This indicates that the device was approved based on its similarity to existing, approved devices and compliance with regulatory guidelines, rather than a standalone performance study with quantifiable acceptance criteria.

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