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The CB DDH Femoral Stem is intended for noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and revisions of hip replacement components.

The Co-Cr-Mo Color Buffed DDH Femoral Stem is designed to replace a diseased or damaged femoral neck. The proximal area of the stem has been reduced slightly to allow a better fit in patients with more of a cylindrical canal.

This 510(k) summary for the Color Buffed (CB) DDH Femoral Stem explicitly states that clinical testing was NOT used for the support of this 510(k). Instead, mechanical testing was used to demonstrate substantial equivalence to a previously cleared device (K992903).

Therefore, the requested information regarding acceptance criteria derived from clinical studies, device performance in clinical settings, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be provided based on the provided document.

The document indicates:

• Clinical Testing: "Clinical data was not used for the support of this 510(K)."
• Non-Clinical Testing: "Mechanical testing was used to demonstrate substantial equivalence."

Without clinical data, none of the detailed information you requested regarding acceptance criteria and a study proving those criteria are met (which would inherently involve clinical performance metrics) can be extracted from this submission.

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