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The indications for the Ascent™ Anterior Stabilized Tibial Bearings are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is to be used with bone cement.

The Ascent™ Anterior Stabilized Tibial Bearings are manufactured from ArCom®, an ultra-high molecular weight polyethylene (UHMWPE). The anterior stabilized tibial bearings are available in varying thicknesses and widths. The Ascent™ Anterior Stabilized Tibial Bearings are used in conjunction with the Ascent™ Primary Femoral Components.

This document states that no clinical testing was provided as a basis for substantial equivalence for the Ascent™ Anterior Stabilized Tibial Bearings.

Therefore, the following information regarding acceptance criteria and a study proving the device meets those criteria cannot be provided from the given text:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set and data provenance
• Number of experts and their qualifications used to establish ground truth
• Adjudication method
• MRMC comparative effectiveness study results or effect size
• Standalone performance
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The document explicitly states: "Non-Clinical Testing: Engineering Justifications determined that the Ascent™ Anterior Stabilized Tibial Bearings presented no new risks and were, therefore, substantially equivalent to the predicate device. Clinical Testing: No clinical testing was provided as a basis for substantial equivalence."

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