(156 days)
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:
- 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 resections
- 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 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.
§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.