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The Prime Modular Endo Heads, with the Prime Cemented Femoral Stems, are intended to replace the femoral head in cases of femoral head and neck fracture, nonunion of femoral head and neck fractures, femoral head aseptic necrosis, osteoarthritis, rheumatoid arthritis and revision of failed hip fracture treatment.

The Prime Modular Endo Heads feature a one piece spherical endo head and a Morse-type taper. This Morse-type taper provides for modular component selection, allowing the head to attach to the Prime Cemented Calcar Femoral Stems. The Prime Modular Endo Heads are provided in diameters from 36mm to 70mm in 1 mm (one millimeter) increments. It is constructed from Cobalt-Chrome Alloy, per ASTM F-1537. Sold Presterile.

This document is a 510(k) summary for a medical device (hip joint femoral prosthesis). It describes the device, its intended use, and compares it to substantially equivalent products. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical or performance validation study report for an AI/algorithm-based device.

The provided text is from a regulatory submission (510(k)) for a physical medical device (orthopaedic implant). The questions in your prompt are geared towards the validation of a software or AI-based medical device, which is a different type of submission and validation process.

Therefore, I cannot extract the requested information from the provided text because it does not exist within this document.

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