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General total knee arthroplasty indications include:
• Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis

• · Post-traumatic loss of knee ioint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
  · Revision of previous unsuccessful knee replacement or other soft tissue stability is adequate
  · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques

The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament.

The ACS® LD FB Knee System is intended for cemented use, single use only.

The ACS® LD FB Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

The ACS® LD FB Knee System is a modular knee replacement system offering various components that can be combined to replace the knee joint with various options depending upon the size and anatomy of each patient. The ACS® LD FB Knee System consists of:

• . ACS® LD Femoral Components
  • o ACS® LD Femoral Component
  • o ACS® LD Femoral Component Slim
  • o ACS® LD PS Femoral Component Slim
  • o ACS® LD PS Femoral Component
  • o ACS® LD SC Femoral Component
• ACS® LD FB+ Tibial Components ●
  • o ACS® LD FB+ Tibia
  • o Locking Plug for ACS® FB Tibial Component
  • o Cone Plug for ACS® FB Tibial Component
• ACS® FB+ PE-Inserts ●
  • o ACS® FB+ PE-Insert
  • ACS® FB+ PE-Insert Hyperflex o
  • ACS® FB+ PE-Insert Ultra o
  • o ACS® FB+ PS PE-Insert Hyperflex
  • o ACS® FB+ SC PE-Insert
  • ACS® Double Taper
• ACS® Stem ●
• o ACS® LD Extension Stem Male Taper
• o ACS® Stem
• ACS® Spacers .
  • o ACS® FB Tibial Spacer
  • o ACS® FB screw for spacer
  • o MK Femoral Spacer
• o MK Screw for Spacer
• ACS® Patella Replacements
  • o ACS® PE-Patella

The ACS® LD FB Knee System is available as a non-coated (LD) fixed bearing (FB) version. The tibial and femoral components are available in cemented version.

This FDA 510(k) Premarket Notification is for the ACS® LD FB Knee System, a knee replacement system. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through performance testing. It does not describe the acceptance criteria and study for an AI/ML device.

Therefore, I cannot extract the information requested regarding acceptance criteria, study details (sample size, provenance, expert qualifications, etc.), MRMC studies, standalone performance, or ground truth establishment for an AI/ML device from the provided text.

The provided text details the regulatory approval process for a traditional medical device (knee implant) and its physical and mechanical performance testing, not an AI/ML diagnostic or therapeutic device.

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