(36 days)
The DePuy Marathon Cross-linked Polyethylene Acetabular Cup Liners are intended to be used with the DePuy Duraloc metal acetabular shells to resurface the acetabular socket in cementless total hip replacement.
The DePuy Marathon Cross-linked Polyethylene Acetabular Cup Liners are intended to be used with the Duraloc System Acetabular Cups to resurface the acetabular socket in cemented or cementless total hip arthroplasty.
The DePuy Marathon Cross-linked Polyethylene Acetabular Cup Liners are UHMWPE acetabular cup liners that are available with 28mm or 32mm inner diameters and with a neutral or 10° lip. The 28mm liners are available in sizes to fit Duraloc metal acetabular shells with outer diameters of 48-74mm. The 32mm liners are available in sizes to fit Duraloc metal acetabular shells with outer diameters of 52-80mm. The polyethylene liners are locked into the Duraloc metal shells with a metal wire locking ring which is supplied with the metal shells.
The Marathon Acetabular Cup Liners are manufactured from UHMWPE that has been cross-linked by exposure to radiation in a very low oxygen environment and then heat treated prior to machining of the liners. The cross-linked polyethylene has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to oxidation and wear. Marathon cross-linked UHMWPE meets all of the specifications of ASTM F648.
This document describes the DePuy Marathon Cross-linked Polyethylene Acetabular Cup Liners. The provided text refers to a 510(k) premarket notification for a medical device and doesn't contain information about an AI/ML device study. Therefore, I cannot fulfill your request for an AI-specific study breakdown. However, I can extract information related to the device's performance claims and the study backing those claims based on the provided text.
Here's a breakdown of the information that is available in the provided document, adapted to your requested format where possible, and explicitly stating why certain AI/ML-specific fields cannot be filled:
Acceptance Criteria and Device Performance
The device's acceptance criteria, in terms of proving "reduced wear," are implicitly defined by the comparative wear data against a predicate device (conventional UHMWPE cups). The study aims to demonstrate a significantly lower wear rate for the Marathon cross-linked UHMWPE liners.
| Acceptance Criteria Category | Specific Criteria/Metric | Reported Device Performance (Marathon Cross-linked UHMWPE) |
|---|---|---|
| Wear Reduction | Against highly polished femoral balls | 85-86% less wear than conventional UHMWPE |
| Wear Reduction | Against moderately roughened femoral heads | 74-79% less wear than conventional UHMWPE |
| Wear Reduction | Against severely roughened femoral heads | 17-56% less wear than conventional UHMWPE |
Note: The document explicitly states: "These in vitro results have not been correlated to clinical experience." This is a crucial disclaimer indicating that while the device performs well in a lab setting, its long-term clinical performance (which would involve human patients and outcomes) is not covered by this study.
Study Details (Non-AI/ML Device)
Here's a breakdown of the study attributes based on the provided text. Many fields are not applicable or cannot be determined for this type of medical device assessment.
| Information Requested | Details from the Document |
|---|---|
| 2. Sample size for test set and data provenance | The study involved "10 million cycle hip simulator wear data." The "sample size" refers to the specific number of cups tested, but this is not explicitly stated. The data provenance is in vitro (laboratory-based simulation), not human patient data. No country of origin for the data is mentioned, as it's a lab test rather than clinical data from a specific region. |
| 3. Number of experts and their qualifications for ground truth | Not applicable. This is an in vitro mechanical wear study, not an AI/ML study requiring expert ground truth for image or data interpretation. |
| 4. Adjudication method for the test set | Not applicable. There is no expert adjudication in a mechanical wear test. The measurement of wear is typically done quantitatively and objectively. |
| 5. Multi-reader multi-case (MRMC) comparative effectiveness study | No. This is a mechanical wear test comparing material performance, not a clinical study involving human readers or AI assistance. |
| 6. Standalone (algorithm only without human-in-the-loop) performance | Not applicable. This is a medical implant, not an algorithm. The "standalone" performance refers to the device's mechanical wear characteristics as measured in the simulator. |
| 7. Type of ground truth used | Mechanical Wear Measurement. The "ground truth" for this study is the quantified amount of material loss (wear) from the acetabular cups, measured directly following the hip simulator testing. This is a scientific, objective measurement. |
| 8. Sample size for the training set | Not applicable. This is not an AI/ML study requiring a training set. |
| 9. How ground truth for the training set was established | Not applicable. This is not an AI/ML study requiring a training set. |
§ 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.