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Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory 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.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Traditional Premarket Notification are CoCr and Oxinium Femoral Head line additions in sizes 40 and 44mm and R3 XLPE Acetabular Liner line additions with inner diameters of 40 and 44mm.

The provided text is a 510(k) summary for medical devices (CoCr and Oxinium Femoral Heads and R3 XLPE Liners) seeking clearance based on substantial equivalence. It does not describe an AI/ML device or a study proving that the device meets acceptance criteria. Instead, it details the device description, intended use, and argues for substantial equivalence to previously cleared predicate devices.

Therefore, I cannot extract the information required in your request about acceptance criteria, study details, sample sizes, expert involvement, or ground truth, as these elements are specific to the evaluation of AI/ML performance studies, which is not present in this document.

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