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The Spline Twist implants are intended for surgical implantation in edentulous or partially edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a freestanding single tooth replacement. The use of the 5.0mm implant is recommended when the quantity and density of bone would dictate the use of an implant larger than 4.0mm. In patients with an edentulous mandible, Spline Twist implants may be loaded immediately when at least four implants are placed between the mental foramina and rigidly splinted with a bar.

Spline Twist implants are screw type implants made from titanium alloy. They have the same surfaces as currently available Sulzer Dental implants. The implants are all provided sterile.

The provided text is a 510(k) summary for the Sulzer Dental Inc. Spline Twist dental implant. This document is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/ML medical devices.

The document focuses on comparing the Spline Twist implant's characteristics (intended use, indications, design, material, dimensions, surface, packaging, and sterilization) to existing predicate dental implants (Branemark System and ITI Implants) to establish substantial equivalence.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, or training set size) as this information is not present in the provided text. The document is about a physical dental implant, not an AI/ML device, and thus the structure of evaluation is very different.

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