(27 days)
The Arthrex iBalance TKA System is indicated for use in individuals undergoing surgery for:
• 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 and stability;
• Revisions of previous unsuccessful knee replacement or other procedure.
Additional indications for posteriorly stabilized components:
• Ligamentous instability requiring implant bearing surfaces with increased constraint;
• Absent or non-functioning posterior cruciate ligament.
These devices are single use only and are intended for implantation with bone cement.
The Arthrex iBalance Total Knee System consists of femoral devices, tibial trays, tibial bearing and patellar devices. All devices are available in a range of sizes to fit varying anatomical requirements. Femoral devices and tibial bearing devices are available in both posteriorly stabilized (PS) and cruciate retaining (CR) configurations. Femoral devices are available in left and right versions and are designed to work with the Arthrex dome patella devices. Femoral and tibial tray devices are manufactured from Cobalt Chromium Alloy conforming to ASTM F75. Tibial bearing and patellar devices are manufactured from UHMWPE conforming to ASTM F648.
The Arthrex iBalance Patella Implant, Dome subject of this application is comparable to the system's current dome patella devices with the exception that the proposed device will be offered in a larger size to further compliment the Arthrex iBalance Total Knee System product offering.
The provided document is an FDA 510(k) premarket notification for the Arthrex iBalance Patella Implant, Dome. It states that the device is substantially equivalent to a predicate device and provides information on its intended use, design, and materials.
However, this document does NOT contain information about acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity for a diagnostic device), sample sizes for test sets or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types, which are typically associated with AI/ML-driven medical device submissions.
The document is for a traditional medical device (a knee implant), not an AI/ML device. Therefore, the requested information (related to AI/ML evaluation) cannot be extracted from this document.
To fulfill the request, a document describing the evaluation of an AI/ML-driven medical device would be needed.
§ 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.