(171 days)
The DePuy Pinnacle AltrX Acetabular Cup Liners are indicated for use in total hip replacement procedures.
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The Pinnacle AltrX Acetabular Cup Liners are indicated for use with Pinnacle Acetabular Cups in cementless applications.
The DePuy Pinnacle ALTRX Acetabular Liners are 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-6Al-4V). The liner component articulates with a metal or ceramic femoral head of an appropriate diameter. The subject devices represent additional sizes and style combinations of the predicate acetabular liners.
The DePuy Pinnacle ALTRX Acetabular Liners are a medical device used in total hip replacement procedures. The 510(k) summary provides information on the device's acceptance criteria and the study that proves it meets these criteria.
Acceptance Criteria and Device Performance
The acceptance criteria for the DePuy Pinnacle ALTRX Acetabular Liners are implicitly demonstrated by showing substantial equivalence to legally marketed predicate devices. The study conducted was a non-clinical test that focused on specific performance requirements.
Here's a table summarizing the characteristics of the subject device in comparison to its predicate and reference devices, which effectively serve as the acceptance criteria based on equivalence:
| Characteristic | Acceptance Criteria (Predicate/Reference) | Reported Device Performance (Subject Device) |
|---|---|---|
| Intended Use | Total Hip Arthroplasty | Total Hip Arthroplasty (Same) |
| Material | UHMWPE, GUR 1020 (Predicate)/GUR 1050 (Reference) | UHMWPE, GUR 1020 |
| Fixation | Uncemented | Uncemented (Same) |
| Compatible Acetabular Shell Diameters | 44-76 mm (Predicate), 38-76 mm (Reference) | 52-76 mm (New sizes added within acceptable range) |
| Compatible Femoral Head Diameters | 28, 32, 36, 40, 44, and 48 mm (Predicate/Reference) | 28, 32, 36, and 40 mm (Subset of compatible sizes) |
| Minimum Cross-sectional Thickness | 3.14 mm (Predicate), 3.25 mm (Reference) | 3.05 mm (Slightly thinner but justified by testing) |
| Sterile Method | Gas Plasma | Gas Plasma (Same) |
| Packaging | Double PETG blister with Tyvek peel lid | Double PETG blister with Tyvek peel lid (Same) |
| Shelf Life | 5 years | 5 years (Same) |
| Impingement Performance | Met applicable performance requirements (implied by predicate clearance) | Demonstrated to meet applicable performance requirements |
| High Angle Fatigue Performance | Met applicable performance requirements (implied by predicate clearance) | Demonstrated to meet applicable performance requirements |
| Push-out Performance | Met applicable performance requirements (implied by predicate clearance) | Demonstrated to meet applicable performance requirements |
| Torque-out Performance | Met applicable performance requirements (implied by predicate clearance) | Demonstrated to meet applicable performance requirements |
The device performance, as reported, indicates that the subject devices "met the applicable performance requirements and are as safe and effective as a legally marketed device."
Study Details
Given that this is a 510(k) submission for a line extension, the primary "study" is a demonstration of substantial equivalence through non-clinical testing.
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Sample size used for the test set and the data provenance:
- No specific sample sizes for test sets are provided in the document. The testing mentioned (Impingement, High Angle Fatigue, Push-out, and Torque-out) would involve specific numbers of physical samples of the liners and associated components, but these numbers are not detailed here.
- Data Provenance: The data is from non-clinical tests conducted by the manufacturer, DePuy Orthopaedics. The country of origin of the data is not explicitly stated but is implied to be within the company's testing facilities, likely in the US (Warsaw, IN). The tests are prospective in the sense that they were conducted for the purpose of this submission to demonstrate performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For non-clinical performance testing of medical devices like acetabular liners, the "ground truth" is typically established by engineering standards and validated test methodologies. There isn't a concept of medical "experts" establishing ground truth in the same way as, for example, reviewing medical images. The acceptance criteria for these tests (e.g., maximum force, cycles to failure) are derived from industry standards, regulatory requirements, and historical data from similar, cleared devices. The engineers and technicians who conduct and interpret these tests are qualified in biomechanical testing and materials science, but their specific number or qualifications are not provided here.
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Adjudication method for the test set:
- Not applicable in the traditional sense. Non-clinical mechanical tests are generally quantitative, and their outcomes are determined by meeting predefined engineering specifications and statistical analysis, rather than through expert human adjudication.
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If a multi-reader, multi-case (MRMC) comparative effectiveness study was done:
- No, a MRMC comparative effectiveness study was explicitly stated as not conducted. The document states, "No clinical tests were conducted to demonstrate substantial equivalence." This type of study is typically used for diagnostic or screening devices involving human interpretation of data (e.g., radiology images).
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant (acetabular liner) for hip replacement, not a software algorithm.
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The type of ground truth used:
- The ground truth for the non-clinical tests (Impingement, High Angle Fatigue, Push-out, and Torque-out) is based on established engineering performance requirements and industry standards for such orthopedic implants. The reported performance of the subject device was compared against these predefined acceptable limits (derived from the predicate devices and general orthopedic device standards) to ensure it performs "as safe and effective as a legally marketed device."
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.