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

The World 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 manufactured from cast cobalt chromium alloy and are intended for use with or without bone cement. The cementless variants are additionally coated with cobalt chromium beads and hydroxyapatite. The cemented femoral components are also available as a symmetrical variant. The femoral component may be used with modular pegs. The modular femoral peg is manufactured from wrought cobalt chromium allov. The femoral component, meniscal inserts and all polyethylene tibias are available as postererior stabilized or cruciate retaining variants.

Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. All variants of the all polyethylene tibia, meniscal insert and patella are manufactured from UHMWPE. The patella components are available in a spherical or non-symmetrical designs.

The provided text describes the regulatory clearance of the "World Total Knee System" by Signature Orthopaedics. This document is a 510(k) premarket notification letter from the FDA, and it focuses on demonstrating substantial equivalence to previously cleared predicate devices, not on proving that the device meets specific acceptance criteria through a clinical study or standalone performance testing in the way an AI/software device would.

Therefore, the requested information components (1, 2, 3, 4, 5, 6, 7, 8, 9) regarding acceptance criteria, sample sizes, ground truth establishment, expert validation, and MRMC studies are not applicable to this type of device clearance document.

Instead, the document details:

• Non-clinical testing and engineering evaluations were conducted to verify performance. These included:

  • Range of motion analysis
  • Component contact area and stress testing
  • Porous coating characterization, shear strength, tensile strength, and shear fatigue testing

• The company claims substantial equivalence to several predicate devices based on:

  • Same intended use and indications for use.
  • Similar materials (cast cobalt chromium alloy, UHMWPE, hydroxyapatite, wrought cobalt chromium alloy).
  • Similar geometry for specific components (e.g., Symmetrical World Knee femur to Total Joint Orthopedics Klassic Knee System, World Knee All Poly Tibia to Smith & Nephew Genesis II Knee System's All Poly Tibia, World Knee patellas to Signature Orthopaedics World Knee System, Signature Orthopaedics Genius Knee System, and Smith & Nephew Genesis II Knee System's patellas).

In summary, this document is for a medical device (knee prosthesis) seeking 510(k) clearance, which relies on demonstrating substantial equivalence through non-clinical performance and material comparisons, not typically through clinical trials with acceptance criteria, ground truth, or expert review like a digital health or AI-driven device would.

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