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This device is indicated for:

• Moderate to severe knee instability
• Sigmificant bone loss and/or ligament deficiencies caused by neoplasms, traumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, and/or avascular necrosis of the proximal and/or proximal tibia.
• Valgus, varus or flexion deformities
• The salvage of previously failed surgical attempts
• A total femoral replacement consisting of the MOST Options® or Segmental proximal femoral, Segmental System segments and Segmental System distal femoral components may be used without cement.
• Variable Stiffness stem extensions require the use of either a smooth or Trabecular Metal stem collar, which must be cemented to the stem. Following cementing to the stem, the smooth collar must be cemented against the bone. The remainder of the stem must be used uncemented.
• · Fluted stem extensions require the use of either a smooth or Trabecular, which must be cemented to the stem. Following cementing to the stem extension, the smooth collar must be cemented against the bone. The remainder of the stem must also be cemented against the bone.
• · The Trabecular Metal collar may be used cemented or uncemented against the bone.
• All other constructs are for cemented use only.

The Zimmer Segmental System is intended to replace the proximal femur, mid-shaft femur, distal femur, proximal tibia and/or total knee in cases that require extensive resection and restoration. The Segmental System provides for cross compatibility between selected components from the MOST Options® System and NexGen® Rotating Hinge Knee System. A total mid-calf to hip replacement can be achieved using the Segmental System. The cleared distal femoral and the proposed distal femoral components are designed to be compatible with standard NexGen patella components.

I am sorry, but the provided text is a 510(k) summary for a medical device (Zimmer Segmental System XT Components), which focuses on establishing substantial equivalence to a predicate device. It does not describe a study that proves the device meets acceptance criteria in the context of an AI/ML device.

Therefore, I cannot extract the information requested regarding:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

The document explicitly states under "Clinical Performance and Conclusions:" that "Clinical data and conclusions were not needed for this device." and mentions "results of non-clinical (lab) component fatigue performance testing" but does not provide details on specific acceptance criteria or performance metrics in a way that aligns with an AI/ML device evaluation.

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