(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. |
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K 994415
y 2+2
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988 |
|---|---|
| 510(k) CONTACT: | Cheryl HastingsDirector, Regulatory Affairs |
| TRADE NAME: | DePuy Marathon™ Cross-linked Polyethylene AcetabularCup Liners |
| COMMON NAME: | Acetabular Cup Prosthesis |
| CLASSIFICATION: | 888.3358 Hip joint metal/polymer semi-constrainedcementless prosthesis |
| DEVICE PRODUCT CODE: | 87 LPH |
| SUBSTANTIALLY EQUIVALENTDEVICES: | DePuy Duraloc Acetabular Cup Liners |
DEVICE DESCRIPTION AND INTENDED USE:
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.
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.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Marathon Cross-linked Polyethylene Acetabular Cup Liners have the following similarities to the acetabular cup liners that were cleared in K972596: same intended use; same material; same method of manufacture; same design; same mating components; same sterilization and packaging methods. DePuy is now adding a labeling claim for reduced wear. This claim is supported by 10 million cycle hip simulator wear data which show that when tested against highly polished femoral balls, the acetabular
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cups manufactured from Marathon cross-linked UHMWPE, (with and without artificial aging) exhibit 85-86% less wear than identical acetabular cups manufactured from conventional UHMWPE. When tested against moderately roughened femoral heads the Marathon cross-linked cups wore 74-79% less than the conventional UHMWPE cups and when tested against severely roughended femoral heads the Marathon cross-linked cups wore 17-56% less than the conventional UHMWPE cups. These in vitro results have not been correlated to clinical experience.
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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 3 2000
Ms. Cheryl Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988
K994415 Re:
Trade Name: Marathon Cross-linked Polyethylene Acetabular Cup Liners Regulatory Class: II Product Code: LPH Dated: January 13, 2000 Received: January 14, 2000
Dear Ms. Hastings:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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Page 2 - Ms. Cheryl Hastings
predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Russell Sage
Sames E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) 9944 | 5
Device Name DePuy Marathon Cross-linked Polycthylene Acetabular Cup Liners
Indications for Use:
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.
Concurrence of CDRH, Office of Device Evaluation
Yunil i-yom. Serzen
(Division Sign-Off) Division of General Restorative Devices 197491 510(k) Number _
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use
000005
§ 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.