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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Correction of functional 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

Biomet Manufacturing Corp. is modifying the manufacturing process of ultrahigh molecular weight polyethylene (UHMWPE) used in the fabrication of polyethylene acetabular mgh molecular naglio partiles. The modified manufacturing process results in a higher cross-linked polyethylene. The highly cross-linked UHMWPE is infused with medical grade Vitamin E.

The provided text is a 510(k) Summary for a medical device (100 kGy E-Poly™ Acetabular Liners- Additional Profiles). It describes the device, its intended use, and claims substantial equivalence to a predicate device.

However, the provided document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria in the way a typical clinical performance study would.

Instead, it states:

• "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
• "Clinical Testing: None provided as a basis for substantial equivalence."

This means the submission relies on non-clinical (i.e., lab-based, not involving human patients) testing to demonstrate that the modified manufacturing process for the UHMWPE used in the acetabular liners results in a product that is substantially equivalent to the previously cleared predicate device (K050327 - E-Poly™ (Vitamin E) Acetabular Liners). Substantial equivalence means that the device is as safe and effective as a legally marketed predicate device.

Therefore, I cannot populate the table and answer the questions as requested because the document explicitly states that no clinical performance study was conducted or provided. The "acceptance criteria" here relate to the non-clinical tests demonstrating substantial equivalence, not clinical performance metrics.

If you are looking for a document that does include details on clinical studies, acceptance criteria, and ground truth establishment for a device's performance, this particular submission is not it, as it relies on non-clinical data for substantial equivalence.

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