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Taper-Fit Total Hip System is indicated for the relief of pain and restoration of hip function following the effects of osteo, rheumatoid and inflammatory arthritis, posttraumatic disease effects, avascular necrosis and total hip revision.

The Taper-Fit Total Hip System is a total hip replacement system comprised of three types of components - femoral stems, modular femoral heads and distal stem centralizers. The femoral stem is manufactured from stainless steel in accordance with BS 7252 Part 9 [ISO 5832-7] - "Wrought Stainless Steel Forgings for Surgical Implants" or High Nitrogen Stainless Steel" and is provided with a distal centralizer. The stem is double tapered, collarless and highly polished. The zirconia ceramic femoral heads are manufactured from high purity 3 mol% Yttria Stabilized Zirconia Polycrystals (Y-TZP). Cobalt-chrome femoral heads are manufactured from cast cobalt-chromium alloy to BS 7252 Part 4 [ISO 5832-4]. All femoral head types, by material, are available in short, standard and long neck sizes. The 12/14 bore on each head is designed to fit a 12/14 stem cone.

The provided text is a 510(k) summary for a medical device (Taper-Fit Total Hip System with ceramic femoral heads). It is not a study report or a publication describing a clinical performance study. Therefore, the information required, such as acceptance criteria, reported device performance, sample sizes, expert qualifications, and ground truth establishment, is not present in the provided document.

This document focuses on establishing substantial equivalence to a previously approved device (the Taper-Fit Hip System with stainless steel femoral heads) for regulatory clearance, rather than presenting a detailed clinical or performance study with specific acceptance criteria and results in the way typically found in a study report.

The document mentions "The results of the testing we claim SE to the predicate device based on seen in Section + of the present scennerries/dimensions, in addition to, similar identical remoral stem and nead goometrics unlained allarines, as demonstrated in the test results." This suggests that some testing was performed to compare the new device to the predicate device, likely focusing on mechanical properties, materials, and geometries to demonstrate equivalence, not on clinical performance or diagnostic accuracy.

Therefore, I cannot populate the requested table or answer the questions based on the provided text.

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