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The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:

Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

The CATALYSTEM Femoral Stems are intended for use without bone cement.

The purpose of this Special 510(k) is to notify the FDA of Smith & Nephew's intent to market the CATALYSTEM Femoral Stems with additional femoral head compatibility. The CATALYSTEM Femoral Stems were previously cleared by the FDA under K240381.

The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.

The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options.

The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.

This document is a 510(k) clearance letter for the CATALYSTEM Femoral Stems. It primarily addresses the regulatory approval process rather than detailing a study proving the device meets specific acceptance criteria in the context of an AI/software device.

The provided text does not contain information related to AI/software device performance or studies proving such a device meets acceptance criteria. It describes a medical device (femoral stems for hip replacement) and its regulatory clearance based on substantial equivalence to a predicate device.

Specifically, it states:

• "No clinical tests were performed to support safety and efficacy of the subject device."
• Bench testing was performed for mechanical properties (e.g., fatigue, range of motion, impingement), which are relevant to orthopedic implants, not AI performance.
• The clearance is a "Special 510(k)" primarily for "additional femoral head compatibility."

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI device meets them from this document. The concepts of ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and test sets are not applicable to the information provided in this 510(k) clearance letter for a mechanical implant.

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