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The LPS Upper Extremity is intended for use in replacement of the proximal, mid-shaft or intercalary portion, distal and/or total humerus. This system is especially designed for cases that require extensive resection and restoration. Specific diagnostic indications for use include:

• Primary bone neoplasnms (e.g., osteosarcomas, chondrosarcomas, Ewing's sarcomas) requiring extensive resection(s) and replacement(s) of the proximal and/or distal humerus;
• Metastatic bone disease and pathologic fractures with extensive bone loss or where other forms of treatment such as internal fixation are inadequate;
• Patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (JD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal humerus;
• Patients suffering from congential or acquired deformity, such as post-traumatic deformity and/or arthritis;
• Communited fractures of the proximal, distal and/or humeral shaft where forms of fixation are indadequate;
• Persistent humeral fracture non-union;
• Patients suffering from severe cuff tear arthropathy that does not respond to any conservative therapy or better alternative surgical treatment;
• Revision shoulder or elbow arthroplasty cases requiring extensive resection(s) and replacements of the proximal, distal or total humerus.
• Severe trauma requiring extensive resection and replacement.
  The LPS Upper Extremity components are for CEMENTED USE ONLY.

The LPS Upper Extremity components are designed for the replacement of the mid-shaft or intercalary portion of the humerus, proximal, distal and/or total humerus. Unlike primary shoulder and elbow systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, end-stage revision). A total humeral replacement is possible in those cases where no part of the humerus can be salvaged.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance results, or any study conducted to prove the device meets specific criteria. The document is a 510(k) summary for the 'LPS Upper Extremity' device, which outlines its indications for use, device description, and substantial equivalence to previously cleared devices. It does not include details on clinical trials, performance testing, sample sizes, expert ground truth establishment, or any comparative effectiveness studies. Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets them based on the given information.

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