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The Plus Bipolar Prosthesis CoCrMo in intended for use in arthroplasty therapy as a result of femoral neck fractures and is to be used in conjunction with standard femoral replacement implant. This device is intended for Cementless use only.

The PLUS Bipolar Prosthesis CoCrMo is a one-piece hip joint prosthesis comprised of a CoCrMo shell, a polyethylene insert and polyethylene security ring.

The provided text is related to a 510(k) premarket notification for a medical device called the "PLUS Bipolar Prosthesis CoCrMo". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting novel performance studies against specific acceptance criteria.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, study design, expert qualifications, or ground truth establishment.

Specifically, the section "Performance data" explicitly states: "None provided at this time." This indicates that the submission does not include any performance studies to demonstrate the device meets acceptance criteria.

Without this information in the provided text, I cannot complete the table or answer the specific questions about the study design.

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