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The DePuy LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

• malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) . requiring extensive resection and replacement;
• patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., theumatoid arthritis. requiring extensive resection and replacement;
• revision cases for a failed previous prosthesis requiring extensive resection and . replacement:
• severe trauma requiring extensive resection and replacement. .

The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The distal femoral component, the S-ROM Tibial Tray and the non-porous coated straight and bowed stems are intended for cemented use only.

The DePuy LPS Proximal Tibial Component is a modular component that is designed to replace the proximal portion of the tibia. Unlike primary knee systems, the LPS System is used when the amount of bone resection and replacement is extreme (e.g. in oncology cases or endstage revision).

The distal end of the LPS Proximal Tibial Component has a female Morse-type taper that is designed to accept either a DePuy LPS Segment Component or a tibial stem. The proximal/superior surface is designed with a central stem hole to allow it to accept the stem of the LPS tibial plateau/hinge assembly. The top surface has a highly polished mirror pr nish for smooth articulation with the polyethylene component of the tibial plateau/hinge assembly. The anterior surface has a Porocoat beaded Co-Cr-Mo porous coating.

This document is a 510(k) summary for a medical device called the "DePuy LPS Proximal Tibial Component." It describes the device, its intended use, and its substantial equivalence to previously cleared devices. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it involve an AI/algorithm-based device.

Therefore, I cannot provide the requested information in the format specified because the input text does not contain any of the details required for such a response, particularly regarding acceptance criteria, performance metrics, ground truth, expert involvement, or AI/algorithm performance studies.

Based on the provided text, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment) is available as this is a traditional medical device submission, not an AI-powered one.

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