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The 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 Tapered Hip Stem and PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured (PST™) surface provides biological fixation when used in a cementless application.
  The Pipeline Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.

This 510(k) addresses the addition of the following components (already cleared under 510(k) #K122158) to the Pipeline Total Hip System:

• . HA-coated Acetabular Shells feature a thin HA coating applied over the porous structured (PST) shells in a range of sizes,
• . Biolox® delta Ceramic Femoral Heads available in a range of diameters and extension options,
• . 40mm CoCr Femoral Heads, and
• . 40mm inner diameter Highly Crosslinked Vitamin E UHMWPE Acetabular Liners.
  These components are compatible with the total hip system determined substantially equivalent as the Pipeline Total Hip System in 510(k) #K112802 and as the PBP Total Hip System in 510(k) #K122158.

The provided text describes a Special 510(k) Premarket Application for a line extension to the "Pipeline Total Hip System." This type of submission claims substantial equivalence to previously cleared devices. Therefore, the "acceptance criteria" and "study" described are not for a de novo device, but rather the justification for substantial equivalence.

Here's how the information aligns with your request:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) is substantial equivalence to predicate devices. The reported "performance" is that the new components are identical to those already cleared.

2. Sample Size Used for the Test Set and Data Provenance

This submission does not involve a "test set" in the traditional sense of clinical or performance data for a new device. Instead, the "test" is a comparison to existing, cleared devices on the market. The submission asserts that the components are identical to those previously cleared. Therefore, there's no independent sample size or data provenance to report for a specific "test set." The "provenance" for the predicate devices would be based on the information provided in their respective 510(k) submissions (K112802 and K122158), which is not detailed here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a claim of identicality to cleared devices, not a study requiring expert-established ground truth for a new device's performance. The "ground truth" here is the prior FDA clearance of the identical components.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in this type of submission.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical hip replacement system, not an AI-assisted diagnostic or imaging tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a mechanical hip replacement system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the prior FDA clearance and determination of substantial equivalence for the identical components under 510(k) #K122158. The submission argues that since the new components are identical to those previously cleared, their safety and effectiveness are established by the predicate's clearance.

8. The Sample Size for the Training Set

Not applicable, as this is a mechanical device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable, as this is a mechanical device, not a machine learning algorithm.

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