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The Type 3 Femoral Components are intended to be used in primary or revision total hip arthroplasty, specifically in the presence of severe proximal bone loss. These stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components. These femoral stems are designed to be press fit into the proximal femur.

The Type 3 Femoral Components are a series of Titanium femoral stems intended to be used for primary or revision total hip arthroplasty, specifically in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components. These stems are modular, with varying proximal body and distal stem sizes to accommodate various anatomical requirements. These femoral stems are designed to be press fit into the proximal femur. These femoral components are manufactured from Titanium alloy, Ti-6Al-4V, which conforms to the requirements of ASTM specification F 136.

The provided text is related to a 510(k) premarket notification for a medical device called "Type 3 Femoral Components." It details the device's intended use, materials, classification, and substantial equivalence to predicate devices. However, the document does not contain information about acceptance criteria for performance metrics, nor does it describe a study involving human readers, ground truth establishment, or sample sizes in the context of device performance in a clinical or AI-assisted scenario.

The only performance-related statement is: "Testing has demonstrated that the fatigue load carrying capacity of the Type 3 Femoral stems exceeds the minimum ISO load requirements." This is a engineering/mechanical performance test, not a clinical study involving human readers or AI.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth, training set sample sizes, or how training set ground truth was established. These details are typically found in documents describing clinical trials, software performance evaluation, or AI model validation, which is not the nature of this 510(k) summary.

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