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The Tornier Total Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated in the following cases : to relieve severe pain of significant disability in degenerative, theumatoid or traumatic disease of the elow joint; correction of functional deformities; revision procedures where other treatments or device have failed, treatment of fractures that are unmanageable using other techniques. This device is intonded for cemented use only.

The present device modification concerns the evolution of the radial head, which is a part of the I to present device modified scommons on one the the humeral and the ulmar component are unchanged. The radial head is composed of a radial head. The modification consists on the addition of a smaller diameter stem (5 mm ) to the previous range of components. Shance than elect stom 7 to the previous to the cleared device. The assembly of the stem and the radial head is unchanged. The manufacturing methods, intended use, packaging and sterilization of the subjected device are identival to the predicate device.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth for a study.

The document is a 510(k) premarket notification for a device modification to the Tornier Total Elbow Prosthesis. It describes the device, its intended use, and materials. The FDA letter indicates that the device is substantially equivalent to legally marketed predicate devices. However, it does not include the details of any study conducted to prove the device meets specific acceptance criteria using the information you requested.

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