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When a mechanical alignment approach is utilized, 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 configuration, 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.
  When a personalized alignment approach is utilized, 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.
• Moderate valgus, varus, or flexion deformities.

The Persona Personalized Knee System is a semiconstrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones.
The purpose of this submission is to add compatibility for cemented nonporous Persona tibial components with a stem extension to the current Personalized Alignment (PA) surgical technique option. In addition to the modifications regarding personalized alignment, this submission also discusses the updated geometric evaluations for the Persona Personalized Knee System as well as the shelf-life extension (5 years to 10 years) of its Vivacit-E VEXLPE implant components.

I'm sorry, but based on the provided text, I cannot describe the acceptance criteria and a study that proves the device meets those criteria, as the document does not contain this information. The text is a 510(k) premarket notification letter from the FDA to Zimmer Biomet regarding the Zimmer® Persona® Personalized Knee System, confirming its substantial equivalence to previously marketed devices.

The document focuses on:

• The FDA's determination of substantial equivalence (K243293).
• Regulatory information and requirements for medical devices.
• Indications for use of the Zimmer® Persona® Personalized Knee System.
• Identification of predicate devices (K240299, K222566).
• A brief description of the device and the purpose of the submission (adding compatibility for cemented nonporous Persona tibial components with a stem extension to the Personalized Alignment surgical technique; updated geometric evaluations; shelf-life extension for specific components).
• A summary of technological characteristics comparing the subject device to the predicate device, emphasizing their similarities regarding intended use, indications for use, variants/sizes, design features, material, and sterility, and noting a similar shelf life with an extension for Vivacit-E VEXLPE components.
• A general statement about performance data indicating the proposed devices meet established acceptance criteria and are as safe and effective as predicate devices.

However, the document does NOT include:

• A table of specific acceptance criteria and detailed reported device performance against those criteria.
• Information about sample sizes for test sets, data provenance, or the nature of prospective/retrospective studies.
• Details on the number or qualifications of experts used for ground truth establishment.
• Adjudication methods.
• Statements about multi-reader, multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance.
• Information on standalone algorithm performance.
• The specific type of ground truth used (e.g., pathology, outcomes data).
• Sample sizes for training sets or how ground truth for training sets was established.

The text primarily attests to substantial equivalence based on the similarity of the device to existing predicates and a general statement about meeting performance criteria, but it does not elaborate on the specific studies or data that would fulfill your request for detailed acceptance criteria and proof of adherence.

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