(293 days)
This device is part of a total knee replacement system utilized in treating patients who are candidates for primary total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
Noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis
Avascular necrosis of the femoral condyle
Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
Moderate valgus, varus or flexion deformities
Rheumatoid arthritis
Treatment of fractures that are unmanageable using other techniques.
The 3DKnee™ porous coated femoral component is manufactured from CoCr alloy conforming to ASTM F75. The inner surface is porous coated with CoCrMo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in 7 sizes (2-12) and is provided in left and right configurations. The femoral component is designed to match the condyles of the tibial insert for greater congruency and is the same design as the 3DKnee™ cleared in K020114.
I am sorry, but the provided text only contains an FDA 510(k) submission summary for a knee implant device (3DKnee™ Porous Coated Femoral Component). This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as it pertains to AI/algorithm-based medical devices or comparative effectiveness studies.
The document is for a physical medical device (a knee implant) and focuses on describing the device, its indications for use, and its substantial equivalence to a previously cleared device (K020114) based on design, materials, and indications, rather than clinical performance data from a study with acceptance criteria.
Therefore, I cannot fulfill your request for an acceptance criteria table and information about a study proving the device meets those criteria, as that information is not present in the provided text.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.