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The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.

The patient's need for knee replacement should be due to one or more of the following conditions:

• . Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
• Inflammatory degenerative joint disease including rheumatoid arthritis.
• Functional deformity such as varus, valgus or flexion deformities.
• . Revision procedures where other treatments or devices have failed.
• . Fractures that are unmanageable using other techniques.

Signature Orthopaedic's World Knee replacement components may be intended for cemented or cementless use. Please verify whether the particular component is intended for cemented or cementless use by checking the package label.

The intended use of the World Total Knee System is for total knee replacement procedures in skeletally mature patients with structural joint damage. This is the same intended use as previously cleared devices for the World Total Knee System, K181530.

The World Total Knee System is a modular knee system consisting of a femoral component, meniscal insert, a patella and a tibial baseplate or all polyethylene tibia. The femoral component and tibial baseplate components are intended for use with or without bone cement. The femoral component, meniscal inserts and all polyethylene tibias are available as posterior stabilised or cruciate retaining variants. The femoral components are also available as anatomic asymmetrical and symmetrical design variants. The femoral component may be used with modular pegs.

The primary purpose of this Special 510(k) Device Modification to the World Knee System is to notify the FDA of the addition of titanium nitride (TiN) material coating to the femoral components (posterior stabilised{PS}, cruciate retaining{CR}) of the cemented variant. This 510(k) also notifies the FDA of minor design update to the femoral component implant.

Materials: Cast Cobalt Chromium (CoCr) alloy (ASTM F75 and ISO 5832-4) for the femoral component and tibial baseplate, Wrought Titanium-6Aluminium-4Vanadium ELI Alloy (Ti6Al4V ELI, ASTM F136-13) for the femoral peg component and tibial baseplate variant, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) for all variants of the patellar implants, Ultra-High-Molecular-Weight Polyethylene (UHMWPE) or Vit-E HXLPE for the All-poly tibial baseplate components and modular meniscal tibial inserts, and titanium nitride (TiN) for coating cemented femoral components.

The provided text describes a 510(k) premarket notification for a medical device, the "World Total Knee System," seeking clearance for a modification. The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study for an AI/algorithm-based diagnostic or assistive device that would involve a test set, ground truth, and human reader performance.

Therefore, the input document does not contain the information necessary to describe acceptance criteria and a study that proves a device meets them in the context of an AI/algorithm-based diagnostic or assistive device.

The document outlines performance testing for implant components, such as:

• Cytotoxicity testing of TiN coating
• Bioburden testing of TiN coated implant
• Verification of coating pullout strength
• Wear testing for 5 million cycles
• Overlay analysis of femoral component dimensions
• Risk Analysis and Design Control Review

These tests are related to the material properties, manufacturing processes, and mechanical performance of the knee implant, not the diagnostic accuracy or effectiveness of an AI system.

Therefore, I cannot populate the requested table and answer the specific questions about an AI/algorithm study as the provided text pertains to a different type of medical device submission (a knee prosthesis with a material coating modification).

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