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The Pinnacle Metal-On-Metal Acetabular Cup Liners are indicated for use as the acetabular component in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of this prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

The Pinnacle 28mm Metal-On-Metal Acetabular Cup Liners are intended for use with the DePuy Pinnacle Acetabular Shells and 28 mm diameter Co-Cr-Mo femoral heads.

The Pinnacle Metal-On-Metal Acetabular Cup Liner is a metal liner that is intended for use with the Pinnacle Acetabular Shells that have been cleared previously. The liner is offered in both 28 mm and 36 mm inner diameter (ID) sizes with outer diameters (OD) ranging from 48mm through The liner is offered in neutral style only. The metal-on-metal liner is mechanically 66mm. locked with the acetabular shell via a taper junction, and articulates with commercially available prosthetic femoral heads.

The provided documentK023786 is a 510(k) summary for the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liner. This document is a pre-market notification to establish substantial equivalence to a predicate device, rather than a submission involving a novel device or AI/ML algorithm. Therefore, it does not include information typically found in studies for AI/ML devices, such as acceptance criteria, statistical performance metrics, ground truth establishment, or human reader studies.

The document primarily focuses on demonstrating that the new device is "substantially equivalent" to an existing, legally marketed predicate device (DePuy Pinnacle Metal-On-Metal Acetabular Cup Liners, K002883). Substantial equivalence in this context means the device has the same intended use, principles of operation, and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.

Therefore, the requested information categories (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set details) are not applicable to this type of regulatory submission and are not present in the provided text.

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