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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.

The proposed Exactech Alteon 6.5mm Bone Screws represent a modification to the predicate Exactech 6.5mm Cancellous Bone Screws cleared in K993082. Both the predicate and proposed devices have the same intended use, general design features, and basic fundamental scientific technology. The only differences between the predicate and the proposed devices are the following dimensional modifications:

• 1. Deeper hex The hexagonal driver feature depth was increased by .013 inches to provide additional driver engagement when installing the screws.
• 2. Tapered/lengthened shank The shank was lengthened by .016" and tapered.
• 3. Thread form modification The thread form was modified to conform to the dimensions for HB 6.5 screws as outlined in ASTM F543-13.
• 4. Modified tip geometry The tip distal to the screw head transitions to a smaller diameter with a smaller minor thread diameter.
• 5. Self-Tapping Flutes The self-tapping flutes were lengthened to intersect one full thread.

These modifications are proposed to provide surgeons with screws that provide improved self-tapping abilities, and are easier to insert than the predicate screws.

The proposed hip screws are intended to mate with the following Exactech implants:

• . Exactech Novation Crown Cups (K070479, K100269)
• Exactech Novation Crown Cups with InteGrip (K102975) .
• Exactech InteGrip Acetabular Shells (K122798)

The provided text describes a 510(k) submission for the Exactech® Alteon™ 6.5mm Bone Screws, which are a modification of a previously cleared device. However, the document does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving that such a device meets those criteria.

The information provided is for a traditional medical device (bone screws) and focuses on demonstrating substantial equivalence to a predicate device through engineering analyses. It does not involve any AI/ML components, therefore, it cannot address the specific points requested regarding AI/ML device performance, ground truth, expert review, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the provided text, as it pertains to a non-AI/ML device.

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