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The EXp Acetabular Shell Liner is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip Arthroplasty.
   Cemented and Uncemented Applications

The EXp Acetabular Shell Liner is made of polyethylene to which Vitamin E has been added. It is available in both hooded and non-hooded options. The liner is part of a complete total hip system and will be used in conjunction with an acetabular shell, femoral head and femoral stem in total hip arthroplasty. The femoral heads which are to be mated with the EXp Liner are made of Biolox forte, Biolox Delta, or CoCr alloy.

The provided text describes a 510(k) summary for the EXp Acetabular Shell Liner. This documentation focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than conducting a controlled clinical study with acceptance criteria often seen in AI/ML device submissions. Therefore, many of the requested elements for AI/ML device evaluation (like sample sizes for test sets, expert ground truth, MRMC studies, training set details) are not applicable or present in this specific type of submission.

However, I can extract and structure the information related to the performance claims and the studies that support them.

Acceptance Criteria and Study for EXp Acetabular Shell Liner

The submission details several claims regarding the oxidative stability and mechanical performance of the EXp material and the EXp liners, which can be interpreted as the performance goals or "acceptance criteria" for the device to be deemed substantially equivalent. The "reported device performance" are the results of the non-clinical tests conducted to support these claims.

1. Table of Acceptance Criteria and Reported Device Performance

• Maximum ASTM F2102 oxidation index for EXp: increased from 0.1 ± 0.02 to 0.2.
• Maximum ASTM F2102 oxidation index for conventional GUR1050: increased from 0.1 ± 0.04 to 3.8 ± 0.2.
• Ultimate load for EXp (ASTM F2183): remained constant (63.3 ± 8.9 N non-aged, 73.1 ± 5.2 N 4-week-aged).
• Ultimate load for conventional GUR1050: decreased from 71.5 ± 3.0 N (non-aged) to an embrittled condition (no sample could be machined after 4 weeks; 45.7 ± 5.9 N after 2 weeks). |
  | Morphology of EXp UHMWPE is consistent with conventional UHMWPE.
  Criteria: No consolidation defects or voids when imaged at high magnification under scanning electron microscopy. | Freeze fracture analysis and scanning electron microscopy showed both EXp UHMWPE and 25kGy GUR 1050 material demonstrated no consolidation defects or voids at high magnification. |
  | Vitamin E blended into EXp UHMWPE does not elute from the material.
  Criteria: No Vitamin E detected in hexane or isopropanol (IPA) extracts using GC-MS and LC-MS. | GC-MS and LC-MS analysis confirmed no Vitamin E was extracted from EXp material when refluxed in hexane at 74°C for 24 hours (detection limits: 50-250 ppb) or soaked in IPA at room temperature for 18 hours (detection limits: 1000 ppm). |
  | EXp liners remain resistant to oxidation after 5 million cycles of wear testing and artificial aging.
  Criteria: Resistance to oxidation (per ASTM F2102) after wear testing (ISO 14242-1) followed by accelerated aging (ASTM F2003). | After 5 million cycles of wear testing (ISO 14242-1) and subsequent 4 weeks of oxidative aging (ASTM F2003):
• Maximum oxidation index (ASTM F2102) for EXp liners: increased from 0.1 ± 0.02 (non-aged EXp material) to 0.2 ± 0.02 (4-week-aged EXp material). |
  | EXp liners experience no failures from dynamic impingement testing.
  Criteria: Resistance to rim fracture under fatigue loading conditions to 1.0 MC (million cycles) per ASTM F2582, with no failure of the locking mechanism. | Dynamic impingement testing per ASTM F2582:
• Three (3) artificially aged EXp liners were loaded to engage the rim with the femoral neck at 4.6 Nm (70% of static peak dislocation moments).
• All three samples reached run-out (1.0 MC) with no fractures observed and no failure of the locking mechanism. |

Regarding the other requested information, which is more relevant to AI/ML device studies:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not applicable. This submission is for a physical medical device (acetabular liner) and relies on non-clinical, in vitro, and mechanical bench testing, not data analysis from patient studies. The "samples" refer to physical specimens of the material or device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. Ground truth in this context is established by standardized physical, chemical, and mechanical testing protocols (e.g., ASTM, ISO standards), not human expert consensus on images or clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods are typically for subjective assessments or discrepancy resolution in clinical or image-based studies. This submission relies on objective physical measurements.

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 is a physical device, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the performance claims is derived from standardized physical and chemical measurements according to established industry standards (e.g., ASTM F2183, ASTM F2003, ASTM F2102, ISO 14242-1, ASTM F2582).

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling. The material properties are inherent to its manufacturing process and composition.

9. How the ground truth for the training set was established

• Not applicable. As above, no training set is described for this physical device.

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