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The ApeX-LNK Poly™ Acetabular Cup Liners are intended for use with the Apex Modular™ Acetabular Cup, in combination with the Apex Modular, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular . necrosis;
• Rheumatoid arthritis; ●
• Correction of functional deformity: .
• Congenital dislocation; ●
• Revision procedures where other treatments or devices have failed; ●
• Femoral neck and trochanteric fractures of the proximal femur. .

The ApeX-LNK Poly™ Acetabular Cup Liners are manufactured of compression molded, crosslinked and stabilized ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 32 mm diameter, with various offsets.

The provided text describes a 510(k) summary for the "ApeX-LNK Poly™ Acetabular Cup Liners." A 510(k) submission is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission relies on comparison to existing devices rather than new clinical studies or efficacy trials.

Therefore, the document does not contain the kind of information typically found in a study proving a device meets acceptance criteria, such as:

• A table of acceptance criteria and reported device performance metrics (e.g., sensitivity, specificity, accuracy).
• Details about sample size used for a test set or training set.
• Data provenance or origin.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
• Standalone (algorithm-only) performance.
• Type of ground truth used.
• How ground truth for a training set was established.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "basis of substantial equivalence" section (Section 6) explicitly states: "The ApeX-LNK Poly Acetabular Cup Liners described in this submission are substantially equivalent to the predicate devices based on similarities in design, intended use, material and manufacturing methods."

The table provided (Section 5) compares the ApeX-LNK Poly Liners to predicate devices across categories like intended use, design, liner options, head diameters, materials, and sterilization, highlighting similarities rather than presenting performance data against defined acceptance criteria.

In summary, based on the provided text, none of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, or ground truth establishment can be extracted because the submission is a 510(k) for substantial equivalence, not a clinical performance study.

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