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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint confi guration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  Porous components may be used cemented (biological fixation). Augments may be attached via bone cement or screw to the tibial plates and/or femoral components. Splined stem extension components are intended to be used press-fit (uncemented). All other femoral component, tibial plate, stem extension, and fibial augment components are indicated for cemented use only.

The Persona Revision Knee System is a semi-constrained total knee prosthesis consisting of anatomically shaped components designed to resurface the articulating surface of the femoral and tibial bones including:

• Femoral components
• Articular surfaces
• Tibial components
• . Stem extensions
• Femoral and tibial augments
• Femoral and tibial cones
  The large modularity of the componentry of the Persona Revision Knee System including articular surfaces with different levels of constraint, augments, cones and stem extensions provides numerous possible configurations to optimally address the bone and joint condition of the patient in a primary or revision TKA surgery.
  The Persona Revision Knee System also includes nonimplantable tools, or instrumentation, that facilitate the implantation of above described implant components as well as cases and trays to hold these instruments during sterilization and their subsequent storage.

The provided text is an FDA 510(k) clearance letter for the Persona Revision Knee System. It does not contain any information about acceptance criteria, device performance studies, or AI/human reader studies.

The document states that the purpose of the submission is to obtain clearance for "proposed changes to the contraindications for the Persona Revision Knee System" to align with current standard practice and for clarification. Crucially, it explicitly mentions: "Non-clinical or clinical tests are not needed to support the proposed changes to contraindications."

Therefore, I cannot fulfill your request to describe acceptance criteria and study details as this information is not present in the provided text. The document is about a modification to labeling (contraindications) for an already cleared device, not about a study proving new performance claims.

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