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510(k) Data Aggregation
(24 days)
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.
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.
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 Category | Reported Device Performance |
|---|---|
| Design and Geometry | Met performance requirements and demonstrated substantial equivalence to predicates. |
| Wear Testing | Performed to demonstrate substantial equivalence to predicates. |
| Range of Motion Analysis | Performed to demonstrate substantial equivalence to predicates. |
| Materials and Processes | Equivalent 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.
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