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Intended Use: The METS® Smiles Total Knee Replacement is intended for the replacement of diseased or deficient bone around the knee joint.

Indications for Use:

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

The METS® Smiles Total Knee Replacement is for cemented use only.

The METS® Smiles Total Knee Replacement and its components are for single use only

The single use METS® Smiles Total Knee Replacement is intended for the replacement of diseased or deficient bone in the proximal tibia. The femoral component and tibial stems of the system are intended for cemented use only.

The system comprises of the following components:
• Small and standard anatomical femoral knee components with single sized stem for each femoral component;
• A range of tibial options in both small and standard sizes – plastic cased rotating hinge, metal cased rotating hinge or fixed hinge;
• A series of tibial and femoral plateau plates in both knee sizes;
• Hyper-extension bumper pad for soft hyper-extension stop for both knee sizes;
• A pair of bushes, axle and a circlip for both knee sizes.

The materials used in the manufacture of the systems include: titanium (Ti), cobalt-chromium-molybdenum (CoCrMo) and ultra high molecular weight polyethylene (UHMWPE).

The provided text describes a medical device submission (K120992) for the METS® SMILES TOTAL KNEE REPLACEMENT system. It details the device, its intended use, indications for use, and a summary of non-clinical testing and clinical evaluation.

However, the document does not contain the specific information requested about acceptance criteria, reported device performance in a table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment methods for a study proving the device meets acceptance criteria.

The document states:

• Non Clinical Testing: "The results of the non-clinical performance testing demonstrate that the device is safe and effective and substantially equivalent to the predicate devices. The Performance testing included: knee fatigue and wear test, disassembly force testing for the taper connections, ASTM F1800-07 testing."
• Clinical Performance Conclusions: "Clinical evaluation was carried out based upon published papers and post market surveillance."
• Substantial Equivalence: "The METS® Smiles Total Knee Replacement is equivalent to the JTS Extendible Implant, (K092138), AVL Hinge Knee (K051570) and the Repiphysis limb salvage system (K021489) predicate devices. The determination of substantial equivalence is based on the similarity of the intended use, indications for use, design / technological characteristics, materials of composition, method of sterilization, performance data and clinical evaluation."

This indicates that the submission relied on demonstrating substantial equivalence to predicate devices through a combination of non-clinical performance tests and a clinical evaluation based on existing literature and post-market surveillance of the predicate devices, rather than a de novo study with specific quantitative acceptance criteria for the new device.

Therefore, I cannot populate the requested table and answer the specific questions about a study with detailed acceptance criteria, sample sizes, expert involvement, and ground truth, as this information is not present in the provided text. The submission focuses on showing the new device is fundamentally similar and performs comparably to already approved devices.

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