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The KinematX Total Wrist Arthroplasty System is indicated for the replacement of wrist joints disabled by pain, deformity, and/or limited motion caused by:

1. Non-inflammatory degenerative wrist disease of the radiocarpal joint including osteoarthritis, post-traumatic arthritis, and Kienbock's disease
2. Revision where other devices or treatments have failed
3. Scapholunate Advanced Collapse (SLAC)
4. Rheumatoid Arthritis
   The device is intended to be implanted with bone cement.

The KinematX Total Wrist Arthroplasty System is a semi-constrained implant system designed to replace the joints of the wrist to alleviate pain while restoring functionality and mobility of the wrist joints. The system consists of two main, modular components:

1. Radial Implant Assembly: CoCr radial stem and an ultra-high molecular weight polyethylene (UHMWPE) bearing surface that interlocks onto a CoCr tray
2. Carpal Implant Assembly: Baseplate with central peg, index metacarpal screw, hamate screw, and CoCr cap.

This FDA document, K191525, describes the KinematX Total Wrist Arthroplasty System. However, it does not include details about acceptance criteria, device performance tables, sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies. It explicitly states that "No clinical testing was performed."

Therefore, I cannot provide the requested information based on the provided text. The document focuses on establishing substantial equivalence to predicate devices through non-clinical testing (mechanical and cadaveric evaluations) and a comparison of indications for use, materials, and design.

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