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The Modular Acetabular Shell II is a metal hemispherical shell manufactured from Ti-6A1-4V alloy and coated with Cancellous Structured Titanium™ (CSTi™). This device may be implanted with or without bone cement and will be used in conjunction with a snap-in acetabular insert manufactured from ultra-high molecular weight polyethylene (UHMWPe). In order to address various clinical situations, these inserts are available in standard, hooded and hooded protrusio designs.

The Modular Acetabular Shell II may be implanted in a solid configuration or in a screwhole configuration. The shell is provided with screwhole plugs which are sintered in place. The screwhole plugs can be removed intraoperatively before or after implantation if the surgeon opts to enhance fixation of the shell with bone screws.

This document is a 510(k) summary for a medical device (Modular Acetabular Shell II) and does not contain the type of acceptance criteria and study information typically associated with AI/ML-based medical devices.

The provided text focuses on the mechanical and material properties of a hip implant device, and its substantial equivalence to other existing devices based on these properties. It describes physical testing related to:

• Integrity of screwhole plug bonds under fatigue loading.
• Comparability of screwhole surfaces to marketed devices.
• Attachment strength between the acetabular shell and insert.

Therefore, I cannot provide a response filling out the requested table and sections, as the input document does not pertain to the performance evaluation of an AI/ML device in the context of diagnostic accuracy, which is what your questions are designed to cover.

To reiterate, the input discusses:

• Device Type: A hip joint prosthetic (acetabular shell).
• Evaluation Method: Mechanical testing and comparison to predicate devices, not clinical studies involving human readers or AI algorithms for diagnostic tasks.
• Performance Metrics: Durability, bond integrity, attachment strength – not sensitivity, specificity, AUC, etc.

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