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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 kinematic 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 kinematic alignment (KA) surgical technique may only be used with Persona CR femoral components, Persona CR or UC articular surface components, and cemented nonporous Persona tibial components without a stem extension.

Porous coated components may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate, and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

Zimmer Inc Persona Personalized Knee System offers Vivacit-E polyethylene components that are sterile packaged with a shelf life of 5 years. The purpose of this submission is to extend the shelf life of these polyethylene components by re-packaging and re-sterilizing unexpired product and product expired up to 3 months post-expiration date. The rework of these devices to extend the shelf life by an additional 5 years does not change the intended use or fundamental scientific technology of the device.

Based on the provided text, the submission is for extending the shelf life of an existing medical device, the Zimmer Persona Personalized Knee System. It is not a submission for a new AI/ML-driven medical device, and therefore, the document does not contain information about acceptance criteria or a study proving an AI/ML device meets those criteria.

The text focuses on non-clinical data related to:

1. Shelf life extension of the Vivacit-E polyethylene components after ethylene oxide re-sterilization.
2. Biological safety assessment of the re-sterilized components.

The "Summary of Performance Data (Nonclinical and/or Clinical)" section explicitly states that the listed items are "Non-Clinical Tests." There is no mention of a comparative effectiveness study involving human readers with and without AI assistance, or any standalone algorithm performance testing, or the use of experts to establish ground truth for a test set.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving an AI/ML device meets those criteria, as the provided document pertains to a resubmission for a non-AI/ML device's shelf-life extension.

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