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The MUTARS® Proximal Femur Replacement System is a modular hip replacement system offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient.

The MUTARS® Proximal Femur System is intended to for uncemented use in total hip arthroplasty for the following indications:

• Proximal femur replacement in oncology cases where radical resection and replacement of bone is required.
• Limb salvage procedures including surgical intervention failed previous prosthesis, and/or oncology indications, where radical resection and replacement of the bone is required.

Use of this prosthesis is generally only indicated in skeletally mature patients

The MUTARS® Proximal Femur Replacement System is a modular hip replacement system, which combines the offering various components that can be combined to replace the hip joint and address major bone defects with various options depending upon the size and location of the defects of each patient. The MUTARS® Proximal Femur Replacement System includes the MUTARS® Proximal Femur System. The MUTARS® Proximal Femur System is manufactured of TiAls V4 and includes the proximal femur, femoral stem, stem extension piece, connecting part, and screws. The MUTARS® Proximal Femur Replacement System can be used as a total hip system with previously cleared (K163577) modular cobalt chrome femoral head, Ecofit® uncemented titanium alloy acetabular cup and polyethylene liner.

The provided text describes a 510(k) premarket notification for a medical device, the "MUTARS® Proximal Femur Replacement System." This document is primarily focused on demonstrating substantial equivalence to previously marketed predicate devices rather than proving the device meets specific performance criteria through a clinical or algorithmic study with defined acceptance criteria for classification accuracy or similar measures.

Therefore, the information regarding acceptance criteria, study design for proving performance, and details about training/test sets, ground truth establishment, or expert adjudication as typically seen for AI/ML-based medical devices or diagnostic tools, is not present in this document.

The performance testing mentioned (Construct fatigue, Corrosion, Range of Motion, Modular Disassembly) relates to mechanical and physical properties of the implant, not to a study proving diagnostic or prognostic capabilities and therefore does not include the elements requested in the prompt (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, etc.).

No information for the requested points (1-9) can be extracted from the provided text as it is not relevant to the type of device and submission described.

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