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The Patient Specific SMILES Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint. It is indicated for:

• Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis or traumatic arthritis
• Correction of varus, valgus or post traumatic deformity .
• . Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement
• Ligament deficiencies .
• Tumor resection .
• Revision of previously failed total joint arthroplasty .
• . Trauma
• . The fixed hinge tibial component is intended for limb salvage procedures requiring radical resection of bone and soft tissue

The Patient Specific SMILES Total Knee Replacement and its components are for cemented use only.

The Patient Specific Patient Specific SMILES Total Knee Replacement and its components are for single use only.

The Patient Specific SMILES Total Knee Replacement is a patient-specific system that is intended for the replacement of diseased or deficient bone around the knee joint. The system includes three tibial options: 1) metal cased rotating hinge, 2) fixed hinge, and 3) rotating hinge polyethylene tibia. The Patient Specific SMILES Total Knee Replacement and its components are intended for cemented use only.

The materials used in the manufacture of the Patient Specific SMILES Total Knee Replacement include titanium (Ti), cobalt-chromium-molybdenum (Co-Cr-Mo) and ultra-high molecular weight polyethylene (UHMWPE).

The device is for single use only.

The provided text describes a 510(k) premarket notification for a medical device called the "Patient Specific SMILES Total Knee Replacement." While it mentions that the device met acceptance criteria through non-clinical performance testing for fatigue and wear, it does not provide the specific acceptance criteria or the study details requested in the prompt.

The document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed clinical or performance study with defined acceptance criteria and reported device performance.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is not present in the provided text.

The only relevant information from the document related to performance is:

• Performance Data: "The Patient Specific SMILES Total Knee Replacement has been evaluated through non-clinical performance testing for fatigue and wearing testing of the knee and ASTM F1800-07 testing. The Patient Specific SMILES Total Knee Replacement met all of the acceptance criteria."

This statement confirms that testing was done and the device passed, but it lacks all the specific details requested in your prompt.

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