(84 days)
Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
- inflammatory degenerative joint disease including rheumatoid arthritis;
- correction of functional deformity;
- revision procedures where other treatments or devices have failed; and
- treatment of fractures that are unmanageable using other techniques.
Unicondylar knee system is indicated for patients with unicompartmental joint disease secondary to the above indications with or without valgus, varus, or flexion deformities where all ligaments are intact.
The ADVANCE® Unicondylar Knee System components are for single use only.
The ADVANCE® Unicondylar Knee System components are for cemented use only.
The ADVANCE® Unicondylar Knee System contains anatomically shaped, medial, nonporous Co-Cr femoral components. The tibial components will consist of all-poly ultrahigh molecular-weight polyethylene (UHMWPE) tibial implants.
The ADVANCE® Unicondylar Femoral component will be available in four anatomic sizes (to provide coverage of the condyle from posterior to anterior). The anatomic shape of the femoral component necessitates separate left and right configurations.
The ADVANCE® Unicondylar Tibial component will be available in four sizes (universal in shape- no lefts and rights).
The provided text is a 510(k) summary for the ADVANCE® Unicondylar Knee System. It describes the device, its intended use, and states its substantial equivalence to previously cleared predicate devices.
However, the document does not contain any information regarding acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or expert involvement for a study proving device performance.
This document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway than providing detailed performance study data against specific acceptance criteria. The claim of safety and effectiveness is based on this substantial equivalence, materials data, and general testing results without specifying what those tests were or if they involved patient data and performance metrics against acceptance criteria.
Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The document explicitly states:
"The safety and effectiveness of ADVANCE® Unicondylar Knee System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification."
This indicates that the "testing results" are likely bench testing or materials characterization, not a clinical study with detailed performance metrics, ground truth, or statistical analysis against pre-defined acceptance criteria in the way you've outlined.
In summary, none of the requested information (acceptance criteria, device performance table, sample sizes, data provenance, number/qualification of experts, adjudication method, MRMC study, standalone study, type/establishment of ground truth for training/test sets) is present in the provided text.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.