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The Pinnacle" Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

The Pinnacle Constrained Acetabular Liner is indicated for use with the Pinnacle Acetabular Cup in cementless application.

The subject Pinnacle" Constrained Acetabular Liner is intended to be used with the DePuy Pinnacle" metal acetabular shells and Self-centering™ (bipolar) heads to resurface the acctabular socket in cementless total hip arthroplasty.

The Pinnacle" Constrained Acetabular Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-6Al-4V). The liner component articulates with a metal femoral head of an appropriate diameter.

The Pinnacle" Constrained Acetabular Liner mechanically constrains the femoral head within the ID of the liner by providing greater than 180 degrees femoral head capture combined with a titanium constraining ring which fits over the opening diameter of the liner. The UHMWPE liner is held in the metal shell by means of a titanium locking ring.

The subject Pinnacle" Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized face-changing orientation. The liners have inner diameters (ID) intended for use with Self-Centering (bipolar) femoral heads within the 40mm-44mm size range. The 62mm-76mm outer diameters (ODs) are geometrically the same as other smaller OD Pinnacle Acetabular Liners cleared in K043058.

I am sorry, but the provided text from K052079 does not contain information about acceptance criteria, device performance metrics, or details of any studies (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information) that would be used to prove the device meets acceptance criteria.

The document is a 510(k) summary for a medical device (DePuy Pinnacle Constrained Acetabular Liners), which primarily focuses on establishing substantial equivalence to a predicate device based on design, intended use, materials, and manufacturing methods. It states that the "design is identical to the DePuy predicate and does not raise any new issues of safety or effectiveness," which suggests equivalence was established through comparison rather than a detailed performance study with specified acceptance criteria for the new device.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about a study based on the input provided.

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