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Femoral replacement in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This component may also be used with the Distal Femoral segment components of the GMRS™ in total femoral replacement.

It is the intention of Howmedica Osteonics Corp. to offer GMRS™ Proximal Femoral Components in an anteverted style, so both the standard and trochanteric versions will be available in left and right orientations. These new GMRSTM Proximal Femoral Components offer 15 degrees of anteversion.

The current GMRS™ proximal femoral components have the axis of their femoral neck perpendicular to the center plane of the slot formed by the two anti-rotation tabs when viewed from the distal-to-proximal direction. The subject GMRS™ anteverted proximal femoral components have the axis of their femoral neck at 75 or 105 degrees to the center plane of the slot formed by the two anti-rotation tabs when viewed from the distal-toproximal direction. The difference in the degrees of rotation from the currently available component is 15 degrees, which provides 15 degrees of anteversion (left or right) when implanted with the bowed press-fit stems.

The following design features are common to the new Anteverted Proximal Femoral Components, and the existing GMRS™ Proximal Femoral Components:

• . These components are each available in one size.
• These components are fabricated from cast cobalt-chromium alloy that meets the . requirements of ASTM standard F-75.
• 5 degree 40 minute taper angle to accept Howmedica Osteonics' modular femoral . heads with the same taper
• . 70mm replacement length
• . porous coating and suture holes in the A-P direction for tissue attachment
• . threaded insertion feature on the shoulder to allow for the use of an insertion instrument
• . 26mm distal diameter
• 34mm head-neck offset .

The GMRS™ Trochanteric Proximal Femoral Component has increased material in the region of the greater trochanter for surgeons who prefer an anatomically shaped component.

The Standard and Trochanteric Proximal Femoral Components of the GMRS™ may be used with the GMRS™ Connection Pieces, Extension Pieces and the Press Fit Stems with PureFix™ HA Coating in proximal femoral replacement. These products may also be used with the MRS Body components, and modular stems in proximal femoral replacement.

This document appears to be a 510(k) Premarket Notification summary for a medical device called the "Global Modular Replacement System Anteverted Proximal Femoral Component." It details the device, its intended use, indications, and contraindications. However, it does not include information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as typically required for clinical validation studies of AI/ML-based medical devices.

The information provided is for a traditional medical device (proximal femoral component for hip replacement), not an AI/ML device. Therefore, the questions related to AI/ML device evaluation (like MRMC studies, standalone performance, training sets, etc.) are not applicable to this document.

The 510(k) summary explains that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, rather than novel clinical performance studies against specific acceptance criteria for a new AI/ML algorithm.

Therefore, I cannot populate the requested table and answer the questions based on the provided text, as this document does not contain the type of information you've requested regarding acceptance criteria and scientific study results for an AI/ML device.

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