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The DePuy Porocoat HPS II Hip Prosthesis with Articul-eze taper is indicated for uncemented or cemented use as the femoral components in total hip arthroplasty for replacing the hip joints of patients whose hip joint has been damaged by inflammatory or non-inflammatory degenerative joint disease, fracture or the failure of a previous arthroplasty.

The Porocoat HPS II Hip Prosthesis with Articul-eze Taper is a design modification of the Porocoat HPS II Hip prosthesis which was previously cleared by FDA for cemented use. The design modification consists of changing the diameter of the taper and neck and adding the intended use of cementless fixation. In addition, five new stem sizes (one increased diameter and four reduced length stems) are being added. The material (ASTM F75 Co-Cr-Mo alloy), manufacturing process, intended use (with the exception of the additional indication of cementless use) and the basic design of the Porocoat HPS II Hip Prosthesis with Articul-eze taper have not changed from those of the Porocoat HPS II Hip Prostheses cleared by FDA in 1984.

This document is a 510(k) summary for a medical device (DePuy Porocoat HPS II Hip Prosthesis with Articul-eze Taper). It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.

However, this document does NOT contain information about acceptance criteria, device performance metrics, or any study results in the manner requested by the prompt. This type of 510(k) submission generally focuses on demonstrating substantial equivalence based on comparisons to predicate devices, rather than presenting novel clinical study data with performance metrics against pre-defined acceptance criteria.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth, experts, or study types like MRMC or standalone performance, as this information is not present in the provided document.

To summarize, based on the provided text, the answer to all parts of your request is: The provided document does not contain the information required to answer these questions.

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