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The Pinnacle AltrX™ Acetabular Cup Liners are indicated for use in total hip replacement procedures. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.
   The Pinnacle AltrX Acetabular Cup Liners are indicated for use with the Pinnacle Acetabular Cups in cementless applications.

The Pinnacle AltrX Acetabular Cup Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner manufactured from cross-linked ultra high molecular weight polyethylene (UHMWPE), which locks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.
The subject Pinnacle AltrX liners are cross-linked UHMWPE acetabular cup liners that are available in a neutral, lateralized neutral, lipped or lateralized face-changing orientation. The liners have inner diameters (ID) intended for use with modular, unipolar, self-centering (bipolar), M-Spec or ceramic femoral heads within the 28mm-48mm size range. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Cup Liners, in a 44mm-76mm size range offering.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The text mentions "test devices identified as AltrX™ Polyethylene liners and two control devices identified as Marathon® Polyethylene liners and Enduron® Polyethylene liners." However, the exact number of individual liners tested for each group in the hip simulator wear study is not explicitly stated. The wear rates are provided with standard deviations (e.g., 3.4 ± 0.2 mg/MC), which suggests multiple samples were tested and averaged, but the count is missing.
• Data Provenance: The study was an in-vitro hip simulator wear study. As such, there is no human patient data and therefore no specific country of origin or retrospective/prospective classification.

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

• This question is not applicable. The study is an in-vitro mechanical wear study, not an assessment requiring expert interpretation of medical images or patient outcomes. The "ground truth" is established by the physical measurement of wear in a standardized laboratory setting.

4. Adjudication Method for the Test Set

• This question is not applicable. There was no expert adjudication process for this type of in-vitro mechanical study. The wear measurements were objective.

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

• This question is not applicable. This is not an AI-assisted diagnostic or imaging device. It is a medical implant, and the study focuses on its material properties and wear performance.

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

• This question is not applicable. This is not an algorithmic device. The performance refers to the physical properties of the acetabular cup liner.

7. The Type of Ground Truth Used

• Ground Truth Type: Objective, quantitative measurement of material degradation (wear rate) under simulated physiological conditions.

8. The Sample Size for the Training Set

• This question is not applicable. There is no machine learning or AI component to this device, and thus no training set in the typical sense. The "training" in this context would be the development and manufacturing processes of the material itself.

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

• This question is not applicable for the reasons stated above. The "ground truth" for the material development would have been established through iterative material science and engineering principles, with testing on prototypes, rather than a formal "training set" with established ground truth labels as seen in AI/ML applications.

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