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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. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon.
Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

The proposed Novation Crown CupsTM and Liners are modifications of the previously cleared AcuMatch A-Series predicates. The design features of the subject devices are summarized below:
NOVATION CROWN CUP AND LINERS
No-Hole and Cluster Hole design options
Shells manufactured from titanium (Ti) alloy with plasma coating and an additional hydroxylapitite (HA) coating option
Sphere and taper inner diameter geometry

The provided text describes a 510(k) premarket notification for the Exactech Novation Crown Cup™ and Liners, claiming substantial equivalence to previously cleared predicate devices. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through clinical studies. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this type of regulatory submission as presented in the provided document.

The document states:

• "Engineering evaluations were conducted to verify that the performance of the proposed acetabular components would be adequate for anticipated in vivo use."
• "Based on successful results discussed in this submission, we conclude that the proposed devices are substantially equivalent to the previously cleared predicates."

This implies that the "study" conducted was a series of engineering evaluations (likely bench testing) aimed at demonstrating the new device's performance was comparable to existing cleared devices, not that it met specific clinical performance criteria. The FDA's letter (K070479) confirms the finding of substantial equivalence based on this submission.

Therefore, I cannot provide the specific information requested in your numbered points because it is not part of a 510(k) summary focused on substantial equivalence based on engineering evaluations.

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