(30 days)
- Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- Correction of functional deformities.
- Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
- Moderate valgus, varus, or flexion trauma.
- Knee fractures untreatable by other methods.
- Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components and Primary PCK Components only).
The Freedom Total Knee System, Freedom Stemmed Tibial Components and Freedom PCK Components are indicated for cemented fixation
The Freedom Total Knee System All-Poly Tibial Plate implants have been developed with the desire to expand upon the already clinically successful Freedom® Total Knee System, melding together the best design features of various sub-systems into one. The implants will retain the key benefits of the All-Poly Tibial implant system while leveraging some of the modular, metal-backed systems (K090411, K182574, K243277). Using the All-Poly design, the articular surface, tibial baseplate, and stem are manufactured from a single component. This eliming from modularity, reduces the overall weight and subsidence risk, adds full radiolucency to the tibial implants, and comes at a reduced cost. Like the original All-Poly Implants, these new versions will be manufactured from GUR 1020 (Type 1) UHMWPE per ASTM F648.
To enhance the existing All-Poly Implant designs, the stem of these implants is being upgraded to the larger, finned stem/keel design from the modular Freedom® Total Knee System (K090411). This will provide the new All-Poly Tibial implanted stability post-operatively and allow surgeons to use the same instruments/surgical technique as the modular, metal-backed system. This will improve the harmony between the various Freedom® systems and ensure all produce the same strong clinical results.
This document is a 510(k) Premarket Notification from the FDA regarding a Knee Joint Prosthesis, specifically the Freedom Total Knee System (All-poly Tibial Plate). It does not contain information related to an AI/ML (Artificial Intelligence/Machine Learning) powered medical device. Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria and study data for an AI/ML device.
The document discusses substantial equivalence for a physical medical device (a knee implant) based on mechanical properties, design comparisons, and adherence to existing predicate devices. It does not mention any software, algorithms, or AI components that would require a study with acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC).
To provide the information you're asking for, I would need a document related to an AI/ML medical device.
§ 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.