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The Natural Hip System Porous Stem is identical in design geometry as compared to the predicate IOI Porous Natural Hip Stem, except for the reduction in the neck length. This design change was intended to address various patient population in cases of total hip or hemi-hip arthroplasty. The Natural Hip System Porous Stem employs a Sulzer 12/14 configured neck trunnion for attachment to IOI's femoral heads, including Biolox and Zirconia ceramic heads. featuring a Sulzer 12/14 configured bore. The Natural Hip System Porous Stem is available in both collared and collarless design. The Natural Hip System with Collar employs Cancellous Structured Titanium (CSTi™) porous coating on the inferior surface of the collar. The proximal surface of the Natural Hip System Porous Stem employs anterior angulation to match the anatomic angulation of a natural femur. In addition, the proximal surface of the Natural Hip System Porous Stem employs circumferential CSTi™ porous coating The distal portion of the Natural Hip System Porous Stem employs ribs and flutes on the anterior and posterior sides of the hip stem. In addition, the distal portion of the Natural Hip System Porous Stem employs a flared coronal slot.

This is a 510(k) summary for a medical device (Natural Hip System Porous Stem), not a study evaluating an AI/ML device. Therefore, the requested information regarding acceptance criteria and studies proving the device meets that criteria with respect to AI/ML performance is not applicable.

The document describes a orthopedic implant and focuses on demonstrating substantial equivalence to predicate devices, primarily through design comparisons, material specifications, and theoretical stress analysis. There is no mention of any AI or machine learning component in this device or its evaluation.

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