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The Zirconia femoral head components are to be used with other total hip components as part of a total hip arthroplasty. The components are indicated for cemented and uncemented use for individuals undergoing primary and revision surgery where other treatments or devices have failed for rehabilitating hips damaged as a result of trauma, or non-inflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Indications also include inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with heads involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The devices are for single use. These head devices may be used with stems that are available with cementless or cement fixation.

These zirconia ceramic femoral heads are compatible with the new 12/14 taper interface of the Revision Hip and Tapered Hip Systems and the Spectron and Cobra stems. They are available with neck lengths of +0 to +8, and with outer diameters of 22 - 28 mm. The femoral heads are manufactured from Yttria stabilized tetragonal Zirconia (YTZP).

This document is a 510(k) premarket notification for a medical device (Zirconia Ceramic Femoral Heads) and does not include information about acceptance criteria or a study proving device performance against such criteria for AI/ML based devices.

The provided text describes a medical device, its intended use, and the FDA's regulatory approval process (510(k) clearance), which focuses on demonstrating substantial equivalence to a legally marketed predicate device. This type of submission typically relies on a comparison of design, materials, and mechanical properties to established predicate devices, rather than a clinical trial with acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement for an AI system.

Therefore, I cannot provide the requested information as it is not present in the provided document. The sections you asked for (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) are specific to studies validating the performance of AI/ML algorithms, which is not the subject of this 510(k) submission.

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