K Number
K123019
Manufacturer
Date Cleared
2012-10-22

(24 days)

Product Code
Regulation Number
888.3358
Panel
OR
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

The system is intended for use either with or without bone cement in total hip arthroplasty.

Device Description

The Longevity IT Highly Crosslinked Polyethylene Liners are intended to be used with either Continuum or Trilogy IT Acetabular components in Total Hip Arthroplasty. The liners are available with neutral, elevated, offset, and oblique liner faces in 28, 32, 36, and 40mm articulation diameters.

AI/ML Overview

The provided document describes the modification of Longevity IT Highly Crosslinked Polyethylene Liners and relies on non-clinical performance data for substantial equivalence. Therefore, there is no acceptance criteria or study that proves device meets acceptance criteria in the context of clinical performance as this was not required.

However, the document does detail the non-clinical performance assessment:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria CategoryReported Device Performance
Design and GeometryMet performance requirements and demonstrated substantial equivalence to predicates.
Wear TestingPerformed to demonstrate substantial equivalence to predicates.
Range of Motion AnalysisPerformed to demonstrate substantial equivalence to predicates.
Materials and ProcessesEquivalent to predicates.

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

This information is not applicable as no clinical test set was used. The assessment was based on non-clinical studies. The provenance for the non-clinical testing is implied to be Zimmer, Inc.

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

This information is not applicable as no clinical test set or human expert review was performed.

4. Adjudication Method for the Test Set

This information is not applicable as no clinical test set was used.

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

A MRMC comparative effectiveness study was not conducted as no clinical study involving human readers or patient cases was performed.

6. Standalone Performance Study

No standalone clinical performance study was conducted. The assessment was based solely on non-clinical testing and comparison to predicate devices.

7. Type of Ground Truth Used

The ground truth for the non-clinical assessment was based on:

  • Engineering analysis
  • Risk analysis
  • Results from wear testing
  • Results from range of motion analysis
  • Design and geometry evaluation against established performance requirements for hip prosthesis liners.

8. Sample Size for the Training Set

This information is not applicable as there was no training set in the context of a machine learning or AI algorithm. The "training" for this device's assessment was based on the performance history and characteristics of the predicate devices.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. The "ground truth" for showing equivalence was based on the previously cleared predicate devices' performance and characteristics, which themselves would have been established through a combination of non-clinical and, where applicable, clinical data. For the current submission, the focus was on demonstrating that the modified device's non-clinical performance matched that of the predicates.

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.