Search Results

The PCA® Constrained Acetabular Liners are intended to be used with the various components of the PCA® Total hip System in the replacement of the acetabulum and femoral head bearing surface secondary to degenerative joint disease, trauma, or failed previous prosthesis. These constrained liner components provide the surgeon with an alternative method in treating the total hip replacement patient who chronically dislocates.

A Constrained Acetabular Insert is intended for use as a component of a total hip prosthesis in revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

This 510(k) submission is a line extension intended to add PCA® Constrained Acetabular Liners to the PCA® Total Hip System.

This document describes a 510(k) premarket notification for a medical device, the PCA® Constrained Acetabular Liners. It is not a study report or clinical trial. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly available in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of acceptance criteria with corresponding device performance metrics (e.g., sensitivity, specificity, accuracy, etc.) related to a clinical study. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a novel study.

The document states:

• "The subject PCA® Constrained Acetabular Liners share intended use, design concepts, and demonstrated comparable mechanical properties to the predicate components and are substantially equivalent to these devices."

This implies that the "acceptance criteria" are implicitly met by demonstrating comparable mechanical properties and design to the predicate device, which is the core of a 510(k) submission. However, specific, quantifiable performance metrics beyond "comparable mechanical properties" are not detailed.

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

Not applicable. This is a 510(k) submission, not a new clinical study with a test set of data as would be used for AI/diagnostic devices. The submission relies on demonstrating equivalence to predicate devices, potentially through bench testing of mechanical properties, but no clinical 'test set' in the traditional sense is described.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No "ground truth" establishment from experts for a test set is described in this 510(k) pertaining to a new clinical study. The 'ground truth' for substantial equivalence is based on existing regulatory frameworks and characteristics of the predicate device.

4. Adjudication Method

Not applicable. No clinical study with adjudication of results is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a study involving human readers or AI in a diagnostic or interpretive capacity. It's a submission for a hip implant component.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This device is a physical hip implant component, not an algorithm.

7. Type of Ground Truth Used

The 'ground truth' in this context is the performance and safety profile of the legally marketed predicate devices. The new device aims to demonstrate substantial equivalence to this established 'truth'. For mechanical properties, the ground truth would be established engineering standards and test results for the predicate devices.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable.

Ask a specific question about this device