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Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. The Pinnacle Revision System is intended to be used to resurface the Acetabular socket in cementless total hip arthroplasty.

The Pinnacle" Revision System is indicated for total hip replacement in the following conditions:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, l. rheumatoid arthritis, or congenital hip dysplasia.
• Avascular necrosis of the femoral head. 2.
• Acute traumatic fracture of the femoral head or neck. 3.
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, 4. hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
• 5. Certain cases of ankylosis.

The Pinnacle™ Revision System Porocoat® porous-coated Acetabular Cup Shell components arc indicated for cementless application.

The Pinnacle™ Revision System is a modular system for resurfacing the acetabulum in total hip arthroplasty. It is a line extension of the DePuy Pinnacle™ Acetabular System. The system consists of two separate units, a shell and a liner. The shell substrate is manufactured from forged or wrought titanium alloy (Ti-6AL-4V). The outer porous-coating (Porocoat®) consists of commercially pure titanium beads metallurgically bonded to the shell substrate. The interior of the shell is designed to mate with a variety of styles of liners that lock into the liner is manufactured from Ultra-high molecular weight polyethylene (UHMWPE). The liners contain multiple ARDs (anti-rotation devices) that engage mating shell features to prevent rotation within the shell. The ARDs enable variable rotational alignment of Face Changing (+4 / 10°) and Lipped liners for patient appropriate positioning. The acetabular liner articulates with a compatible femoral head of appropriate diameter.

The Pinnacle™ Revision System extends the existing Pinnacle™ Acetabular System shell options by providing Multihole, Standard Profile and DPx (Deep Profile) configurations. The Revision DPx Shells provide lateralization of the femoral head. Both Revision Standard Profile and Revision DPx shells provide peripheral screw holes in addition to dome screw holes. The screw holes permit use of compatible titanium alloy screws to provide immediate adjunct fixation, stability and intimate contact with bone. The shells contain an apical threaded hole to attach the shell insertion instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical hole plug is available to screw into the threaded apical hole of the shell.

The Pinnacle™ Revision System extends the range of Pinnacle™ Marathon Liners by offering corresponding sizes for 28, 32 and 36mm femoral heads in Neutral, +4, and +4 / 10' degree configurations and a Lipped liner configuration for 28 and 32mm femoral heads.

The provided text is a 510(k) summary for the DePuy Pinnacle™ Revision System, an acetabular cup prosthesis. This document focuses on demonstrating substantial equivalence to existing devices rather than presenting a study where acceptance criteria are directly evaluated through performance metrics like accuracy, sensitivity, or specificity.

Therefore, the requested information regarding acceptance criteria, study performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present in the provided text. The document is primarily a regulatory submission detailing the device's description, intended use, and basis for substantial equivalence to predicate devices, which typically involves demonstrating similar design, materials, and intended use as legally marketed products.

The "Basis of Substantial Equivalence" section explicitly states: "Based on the same Intended Use, Indications for Use, materials, sterilization processes and similarities of technological and geometric features, DePuy believes that the subject Pinnacle™ Revision System components are substantially equivalent to the previously cleared DePuy predicate devices." This highlights that the evaluation is comparative against existing devices, not an independent performance study against predefined quantitative acceptance criteria.

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