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The Consensus hip systems are designed for total or partial hip arthroplasty and are only intended to be used with compatible Consensus components per the appropriate system specific indications.

The general indications for use are:

• A. Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis.
• B. Revision of failed femoral head replacement, cup arthroplasty or other hip procedures.
• C. Proximal femoral fractures.
• D. Avascular necrosis of the femoral head.
• E. Non-union of proximal femoral neck fractures.
• F. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities.

Consensus hip system implants are intended for uncemented or cemented use per the system specific indications.

The Consensus hip systems are semi-constrained, hip prosthesis designed for either The Consensuring bio surgery. They include the Consensus® Hip System (CHS), the Unisyn™ Hip System, and the TaperSet™ Hip System (THS). All three hip systems utilize the exact same 12/14 Morse taper trunnion. These hip stems are compatible with previously cleared CoCr heads, zirconia heads, unipolar heads, bipolar heads, UHMWPE inserts and acetabular cups.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for Consensus Orthopedics, Inc.'s hip systems, discussing their device description, indications for use, and substantial equivalence to predicate devices. It explicitly states:

"Clinical Performance Data: No clinical studies were performed."

The "Non-Clinical Performance Data" section mentions "All required testing per 'Guidance Document for the Preparation of Premarket Notifications of Ceramic Ball Hip Systems' were performed," and component testing according to ISO standards, but it does not provide specific acceptance criteria or report device performance against such criteria. It only lists the types of tests done.

Therefore, I cannot provide the requested table or information about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these details are not present in the provided text.

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