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PIPELINE Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia:
• Acute traumatic fracture of the femoral head or neck;
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The PIPELINE Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.

The predicate Pipeline Total Hip System (K112802) and PBP Total Hip System (K122802) are artificial hip replacement systems that include femoral stems (titanium alloy and CP titanium), femoral heads (cobalt chromium or alumina ceramic), acetabular shells (titanium alloy, porous structured technology (PST™)), acetabular liners (ultrahigh molecular weight polyethylene, standard and highly crosslinked Vitamin E), acetabular bone screws (titanium alloy) and dome hole covers (titanium alloy) for the holes in the acetabular shells. This subject 510k adds the following components to the existing hip systems:

• A smaller, size 1 femoral stem; .
• The option of hip stems (all sizes) with 3 tantalum beads, to allow the surgeon to . perform radiostereometric analysis(RSA) to measure implant migration; and
• . The option of acetabular screw hole occluders provided either separately (for assembly by the surgeon), or pre-assembled to the acetabular shells.

The provided text describes a 510(k) summary for a hip replacement system, which details its components, intended use, and substantial equivalence to predicate devices, but does not contain information related to a "device" in the context of an AI/ML algorithm or medical imaging diagnostic device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided document is for a mechanical orthopedic implant, not a diagnostic or AI-powered device.

The questions in the prompt (e.g., "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance") are specific to the evaluation of AI/ML or diagnostic imaging devices, which are not relevant to the Pipeline Total Hip System.

The "Performance Testing" section in the document refers to:

• Hip Stem Fatigue Testing: Conducted according to ISO 7206-4:2010 to determine endurance properties.
• Stem Neck Fatigue Testing: Conducted according to ISO 7206-6:1992 and ASTM F2068-03.
  These are mechanical engineering tests to ensure the structural integrity and durability of the implant under physical stress, not a study to prove diagnostic accuracy or AI performance.

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