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The b-ONE MOBIO Total Knee System is intended for total knee arthroplasty due to the following conditions:

· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), 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.

· Revision of previous unsuccessful knee replacement or other procedure.

· Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture- management techniques.

Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components:

· Ligamentous instability requiring implant bearing surface geometries with increased constraint.

• · Absent or nonfunctioning posterior cruciate ligament.
  · Severe anteroposterior instability of the knee joint.

The b-ONE MOBIO Total Knee System is intended for implantation with bone cement only. b-ONE MOBIO Total Knee System components are not intended for use with other knee systems.

The b-ONE™ MOBIO™ Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.

The purpose of this submission is to add a line extension to the existing system to offer the Tibial Inserts and Patella components in UHMWPE Crosslinked with 0.1% tocopherol.

All system components are supplied sterile and are single use devices.

This is a 510(k) Premarket Notification for a medical device (a total knee replacement system), not for a diagnostic AI/ML device. Therefore, the provided text does not contain the information requested regarding acceptance criteria, study design for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, or ground truth establishment for an AI/ML algorithm.

The document discusses a traditional 510(k) submission for a physical medical device (knee implant), focusing on its materials, design features, and manufacturing processes, and demonstrating substantial equivalence to a predicate device. The "Performance Data" section refers to non-clinical studies (material characterization, wear testing, biocompatibility) for the physical implant material, not the performance of an AI/ML algorithm.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI device meets the acceptance criteria from this document.

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