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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 nonunion of femoral fractures. Use of the 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 Metal-on-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.

The subject of this 510(k) consists of modifications to the Instructions for Use (IFU). The following two contraindications and potential adverse effect have been added to the IFU. DePuy Orthopaedics is making these IFU revisions to comply with a request from Health Canada, as well as to update the contents to reflect current industry practice. These are the only changes to the labeling and IFU; there are no changes to the device design.

This 510(k) submission, K083642, describes modifications to the Instructions for Use (IFU) for the DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners. It is not a submission for a new device requiring performance testing against acceptance criteria. Instead, it focuses on label updates, specifically adding contraindications and a potential adverse effect. Therefore, many of the requested categories related to device performance studies, such as sample sizes, expert qualifications, and ground truth establishment, are not applicable to this particular submission.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. This submission is for labeling modifications to an already cleared device, not for proving the performance of a new device against acceptance criteria. The device's performance was established during the original 510(k) clearances (K062426, K023786, K003523, K002883).

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No new performance testing was conducted.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. No new performance testing was conducted. The changes to the IFU were made "to comply with a request from Health Canada, as well as to update the contents to reflect current industry practice," implying an expert consensus based on clinical experience and regulatory guidance rather than a specific study with a defined number of experts for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. No new performance testing was conducted requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is an implantable medical device, not an algorithm.

7. The type of ground truth used:

Not applicable for new device performance. The "ground truth" for the IFU modifications is regulatory compliance and updated clinical understanding/industry practice, as prompted by Health Canada and general industry evolution.

8. The sample size for the training set:

Not applicable. As this is not an algorithm, there is no training set. The clinical experience and scientific understanding that led to the IFU changes would be based on a broad range of data from previously implanted devices, post-market surveillance, and general medical literature regarding metal-on-metal implants.

9. How the ground truth for the training set was established:

Not applicable.

Summary of the 510(k) Submission:

This 510(k) submission (K083642) by DePuy Orthopaedics, Inc. is a submission for labeling changes only for their DePuy Pinnacle® Metal-on-Metal Acetabular Cup Liners. The changes involve adding two contraindications and one potential adverse effect to the Instructions for Use (IFU). These revisions were made to comply with a request from Health Canada and to reflect current industry practice. No changes to the device design, indications for use, or intended use were made. The FDA determined the device, with its updated labeling, to be substantially equivalent to previously legally marketed predicate devices, allowing its continued marketing.

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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 the 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 Metal-On-Metal Acetabular Cup Liners are intended for use with DePuy Pinnacle Acetabular Shells and M-Spec Co-Cr-Mo femoral heads only.

The Pinnacle Metal-On-Metal (MOM) Acetabular Cup Liner is a metal liner that is intended for use with Pinnacle Acetabular Shells that have been cleared previously. The liners currently are offered with inner diameters (ID) of 28-36mm, this modification is to add 40 and 44mm Ids and to add a 36mm liner with a outer diameter (OD) of 50mm. The liners are offered in a neutral style only. The subject Pinnacle MOM liner is mechanically locked with the shell via a taper junction which is identical to the taper junction used for the cleared 28 and 36mm liners and articulates with previously cleared M-Spec metal prosthetic femoral heads.

The provided text is a 510(k) summary for the DePuy Pinnacle Metal-on-Metal Acetabular Cup Liners. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance data for a device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets those criteria, as this information is not contained within the provided text. The document is for a medical device that has been cleared through the 510(k) process, which relies on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance criteria through a new study.

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Ask a specific question about this device