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The Zirconia Ceramic Modular Heads are used in combination with femoral hip stems and ultra high molecular weight polychylene (UHMWPE) acetabular cups or acetabular cups or acetabular cups or acetabular cup liners to reinstate function following the degenerative effects of osteo or rheumatoid arthritis, post-trauma disease effects, avascular necrosis and septic or aseptic total hip revision.

Device Dooriphon. Polycrystals (Y-TZP), used in total hip replacement surgery.

These Zirconia Ceramic Modular Heads are available in standard Corin trunnion and Euroconc trunnion options. The devices are available in short, standard and long neck and 28mm and 32mm outside diameters.

The bore of the Modular Head is designed so as to ensure compatibility with the conc (trunnion) of the Femoral Stem, and hence locking of the components in situ.

The Corin Medical Zirconia ceramic modular heads incorporate a female trumion (taper). The modular head is applied to the male trunnion of a Corin Medical femoral stom.

The Zirconia ccramic modular heads are designed to articulate with ultra high molecular weight polyethylene (UHMWPE) acetabular cups or acctabular cup liners to roinstate function following the degenerative effects of osteo or theumatoid arthritis, post-trauma disease effects, avascular necrosis and septic total hip revision.

Zirconia ccramic modular heads offer an ultra smooth surface in order to decrease torque and reduce stresses normally associated with the articulation of cobalt chromium alloy femoral heads with ultra high molecular weight polycthylene (UHMWPF) acctabular components.

7.rconia ceramic modular heads are more resistant to third body wear from coment particles than cobalt chromium alloy modular heads. This, in conjunction with their low friction and decreased torque, significantly reduces polycthylene wear related total hip prosstheses problems such as ostcolysis.

The use of zirconia ceramic modular heads also eliminates the release of metallic corrosion particulates into the joint space, which can be found when cobalt chromium alloy heads are mounted onto cobalt chromium alloy femoral stems. These ceramic modular heads are designed for use with cobalt chromium alloy femoral hip stems manufactured by Corin Medical.

This 510(k) premarket notification for the Zyranox Zirconia Ceramic Modular Heads is a regulatory submission for a medical device and, as such, does not contain information about acceptance criteria or supporting studies in the manner typically found in scientific publications or clinical trial reports.

The provided document does not describe acceptance criteria, device performance results, sample sizes for testing, ground truth establishment, or any details of a study proving the device meets acceptance criteria.

The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, as required by the FDA. This typically involves:

• Device Description: What the device is and how it works.
• Indications for Use: What the device is intended to treat or diagnose.
• Comparison to a Predicate Device: How the new device is similar to an already legally marketed device. This often includes comparing design, materials, performance characteristics (e.g., mechanical properties, wear resistance for orthopedic implants), and intended use.
• Non-Clinical Testing Information: Often includes summary data on mechanical testing (e.g., fatigue, static strength, wear characteristics) and biocompatibility, but these are usually presented as meeting standards or specific values rather than as part of a detailed "study" proving acceptance criteria in the clinical sense.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, and ground truth based on the provided text. The document is a regulatory approval letter and a summary, not a detailed study report.

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