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EMPOWR Dual Mobility (Metal Liner and Poly Bearing) is indicated as part of a total hip replacement for patients suffering from pain and dysfunction due to:

• Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
• Revision of previously failed total hip arthroplasty
• Dislocation risks
• To be used for uncemented applications

EMPOWR Dual Mobility (Metal Liner and Poly Bearing) introduces a modular dual mobility bearing to the current acetabular system. The benefit of the new system is enhanced stability due to a larger femoral head with more ROM for a given cup size than the previously cleared single articulation liners. Bearings are offered in nominal OD sizes of 38-58mm compatible with previously cleared cups.

The subject bearing includes a Metal Liner made of CoCr alloy that locks to the cup with a modular taper junction and a Poly Bearing (Head) made from highly crossed linked UHMWPE infused with Vitamin E that captures an Inner Head made of ceramic or CoCr. The bearing provides two articulating surfaces. The Poly Bearing component articulates inside the Metal Liner and the permanently captured Inner Head articulates inside the Poly Bearing. The two articulations can occur independently or simultaneously.

The provided text is a 510(k) summary for the EMPOWR Dual Mobility Metal Liner and Poly Bearing. This document indicates that clinical testing was not required for this device. Therefore, the comprehensive information regarding acceptance criteria and a study proving device performance as requested cannot be extracted from this document, as such a study was not performed or submitted for this regulatory clearance.

However, I can provide the available information:

1. A table of acceptance criteria and the reported device performance:
   Since no clinical study was required or performed, there is no "reported device performance" in terms of clinical outcomes or specific acceptance criteria for clinical efficacy. The device's substantial equivalence was based on non-clinical mechanical testing.

   Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
   Demonstrated ability to perform under expected conditions for: Wear Testing, Metal Liner Disassembly, Head Disassembly, Metal Liner Corrosion, Impingement Testing, Range of Motion.	Mechanical testing demonstrated the device's ability to perform under expected conditions for all listed tests.
   Pyrogen limit specifications met.	Device testing assures pyrogen limit specifications are met via Kinetic Chromogenic method for bacterial endotoxin testing.

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, as no clinical test set was used. Non-clinical testing would involve physical prototypes or samples rather than patient data.

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, as no clinical test set was used requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no clinical test set was used.

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 physical medical implant (hip replacement component), not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical medical implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   Not applicable, as no clinical study or patient data requiring ground truth was used for this submission. The "ground truth" for non-clinical mechanical testing would be the engineering specifications and performance expectations.

8. The sample size for the training set:
   Not applicable, as no AI algorithm or clinical training set was used.

9. How the ground truth for the training set was established:
   Not applicable, as no AI algorithm or clinical training set was used.

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