(126 days)
The Freedom® Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System. The Freedom® Total Knee System is indicated for the following:
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, and polyarthritis.
- Correction of functional deformities.
- Post-traumatic loss of knee join contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods.
The Freedom® Ultra-Congruent Tibial Liner is intended for cemented use only. This device is for single use only.
The Freedom® Ultra-Congruent CR Tibial Liner consists of an ultra-high molecular weight polyethylene (UHMWPE) liner that is designed to be used with the Freedom® Total Knee Cruciate Retaining (CR) Femoral Components in the Freedom® Total Knee System.
I apologize, but the provided text from the FDA 510(k) clearance letter for the Freedom Ultra-Congruent CR Tibial Liner does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The document is a standard FDA clearance letter confirming that Maxx Orthopedics, Inc. can market the device because it has been determined to be substantially equivalent to a legally marketed predicate device. It details:
- The regulatory classification and product code.
- The general controls provisions of the Act that apply.
- The Indications For Use for the device.
It does not include any technical performance specifications, clinical study results, or statistical analyses that would allow me to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding the study design, as that data is not present in the provided text.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.