Search Results

The PINNACLETM Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history or prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options of constrained acetabular components have been considered.

The PINNACLETM Constrained Acetabular Liner is indicated for use with the PINNACLETM Acetabular Cup in cementless application.

The PINNACLE™ Constrained Acetabular Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra-high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-Al6-V4). The liner component articulates with a metal femoral head of an appropriate diameter.

The PINNACLE™ Constrained Acetabular Liner mechanically constrains the femoral head within the inner diameters of the liner by providing greater than 180 degrees femoral head capture combined with a titanium constraining ring which fits over the opening diameter of the liner. The UHMWPE liner is held in the metal shell by means of a titanium locking ring.
The PINNACLE™ Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized face-changing orientation. The liners have inner diameters compatible with standard metal femoral heads sized 28, 32, and 36mm, as well as larger diameter unipolar, Self-Centering (bipolar) and Modular M femoral heads sized 40 and 44mm. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Liners, in a 48mm-76mm size range offering.

This document is a 510(k) premarket notification for the PINNACLETM Constrained Acetabular Liners. The submission is not for a new device but for an expansion of the labeling to include updated MRI compatibility information, standardization of language and symbols, and inclusion of new internationally recognized symbols and implant cards for international markets. Crucially, the document states: "There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices."

Therefore, the acceptance criteria and study information typically associated with a new or significantly modified device, especially regarding clinical performance or algorithm evaluation, are not provided in this regulatory document. The focus of this submission is on demonstrating the device's acceptable performance in an MRI environment.

Here's an analysis based on the provided text, but it will be limited due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

The document focuses on MRI safety evaluation. The acceptance criteria are implicit in the adherence to established ASTM standards for MRI compatibility. The reported performance indicates that the device met these standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "Non-clinical testing" and "full test data present and reviewed in the FDA cleared submission 'K231873 - DePuy Hip Portfolio MRI Bundled Traditional 510(k)'". This indicates that the testing was non-clinical (ex-vivo/in-vitro), not involving human subjects. The sample size would refer to the number of devices or components tested, but this specific detail (the exact number of liners tested) is not provided in this document. The provenance is not explicitly stated beyond "DePuy Ireland UC" as the submitter, implying the testing was conducted or overseen by them.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study involved non-clinical MRI safety testing of a physical device, not an AI or diagnostic device requiring human expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for non-clinical testing of device properties like MRI compatibility.

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

An MRMC study was not done. This submission is for a physical orthopedic implant.

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

This is not applicable. This submission is for a physical orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" here is the objective measurement of physical properties of the device under MRI conditions, compared against the limits established by the referenced ASTM standards.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable for the same reason as above.

Ask a specific question about this device