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All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

• Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only.
• Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
• Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Exactech Novation and AcuMatch E-HXL Acetabular Liners are intended for use in total hip replacement as an interface between acetabular shells and femoral heads. Both Novation E-HXL Acetabular Liners and AcuMatch E-HXL Acetabular Liners are manufactured from Ultra-High Molecular Weight Polyethylene containing vitamin E (alpha tocopherol). The Novation E-HXL Acetabular Liners are available in five configurations (neutral, lipped, anterior lipped, +5mm lateralized, and 10 deg. face changing) with inner diameter ranging between 22mm and 40mm. The AcuMatch E-HXL Acetabular Liners are available in four configurations (0 deg., ext coverage, and +5mm lateralized) with inner diameter ranging between 28mm and 36mm. The overall design goals of the proposed Exactech Novation and AcuMatch E-HXL Acetabular Liners are to improve wear performance and provide oxidative stability in comparison to the predicate Exactech Novation and AcuMatch GXL Acetabular Liners.

The provided text is a 510(k) summary for the Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners. It focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, primarily through non-clinical testing. This type of document describes the device and its intended use, lists predicate devices, and summarizes the non-clinical tests performed to support the claim of substantial equivalence.

It does not contain the kind of information requested in the prompt regarding acceptance criteria and a study proving device meets acceptance criteria, particularly for a diagnostic AI/imaging device. The categories of information requested (e.g., sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are typical for the evaluation of AI-powered medical diagnostic devices, which involve performance metrics like sensitivity, specificity, accuracy, etc., when compared against a defined ground truth derived from human experts or pathology.

Since the provided text describes a hip joint prosthesis component and not an AI/imaging device, it does not include the relevant information to answer your questions. The "Non-Clinical Testing" section lists material characterization, biocompatibility, wear analyses, mechanical testing, and range of motion analysis, which are appropriate for a physical implant, but not for an AI diagnostic algorithm.

Therefore, I cannot extract the requested information from the provided document as it does not pertain to an AI device or a study structured to evaluate diagnostic performance against acceptance criteria in the manner described in your prompt.

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