(27 days)
The Unity™ Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.
General total knee arthroplasty indications include:
• Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
• The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament
The Unity™ Total Knee System is indicated for cemented use, single use only.
The Unity Knee™ is a fixed bearing total knee replacement system that consists of a cobalt chromium alloy (CoCr) femoral component, a UHMWPE polyethylene tibial insert, a cobalt chromium Alloy (CoCr) tibial tray with a titanium alloy keel extension and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee™ is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity Knee™ CR is intended for use in instances where the posterior cruciate ligament (PCL) is functional. The Unity Knee™ PS variant is utilized when a total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The Unity Knee™ patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides titanium alloy augments including femoral augments tibial augments and stem extensions.
I am sorry, but based on the text provided, I cannot fulfill your request. The document is a 510(k) premarket notification for a medical device (Unity Total Knee System) and does not contain any information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies related to an AI/ML device.
The document specifically states under "13. Clinical Testing": "Clinical testing was not necessary to determine substantial equivalence between the Unity™ Total Knee System augment and the predicate devices." This indicates that the device's substantial equivalence was established through non-clinical testing and comparison to predicates, not through performance metrics derived from a study involving human readers or an AI algorithm.
Therefore, I cannot extract the information required to populate the tables and answer your questions about the device's acceptance criteria and the study proving it meets them.
§ 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.