(175 days)
Depuy Duraloc® Cementless Acetabular Cup System, Modified DePuy Acetabular Cup System
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No
The summary describes a physical medical device (acetabular cups) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is an acetabular cup intended for cementless total hip replacement, which is a therapeutic intervention to restore hip function.
No
Explanation: The device is an acetabular cup designed for surgical implantation to resurface the hip socket, not for diagnosing diseases or conditions.
No
The device description clearly states it is a physical implant (porous coated Ti-6Al-4V alloy acetabular cups) used in surgery, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "resurface the acetabular socket in cementless total hip replacement." This is a surgical procedure performed on a patient's body.
- Device Description: The device is a physical implant (acetabular cup) made of Ti-6Al-4V alloy.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
All of the DePuy Duraloc Acetabular Cups are intended to be used with DePuy Duraloc polyethylene liners and locking rings to resurface the acetabular socket in cementless total hip replacement.
Product codes
87 LPH
Device Description
The subject DePuy Duraloc Acetabular Cups are porous coated Ti-6Al-4V alloy acetabular cups which are available in various sizes, ranging from 38mm in outer diameter. All of the cups have screw holes, either dome or peripheral, for adjunctive fixation. All of the DePuy Duraloc Acetabular Cups are intended to be used with DePuy Duraloc polyethylene liners and locking rings to resurface the acetabular socket in cementless total hip replacement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Acetabular socket in cementless total hip replacement.
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Depuy Duraloc® Cementless Acetabular Cup System, Modified DePuy Acetabular Cup System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS
| NAME OF FIRM: | DePuy Inc.
P.O. Box 988
700 Orthopaedic Drive
Warsaw, Indiana 46581-0988 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| FIRM CONTACT: | Sally Foust
Clinical Research Specialist |
| TRADE NAME: | DePuy Duraloc® Acetabular Cups - the Bantam,
Sector, Polished Sector, Polished Sector, Full Profile
Sector, and Deep Profile Solutions Cups |
| COMMON NAME: | Acetabular Cup Prosthesis |
| CLASSIFICATION: | 888.3358 Hip joint metal/polymer semi-constrained
cementless prosthesis |
| DEVICE PRODUCT CODE: | 87 LPH |
| SUBSTANTIALLY EQUIVALENT DEVICES: | Depuy Duraloc® Cementless Acetabular Cup SystemModified DePuy Acetabular Cup System |
DEVICE DESCRIPTION AND INTENDED USE:
The subject DePuy Duraloc Acetabular Cups are porous coated Ti-6Al-4V alloy acetabular cups which are available in various sizes, ranging from 38mm in outer diameter. All of the cups have screw holes, either dome or peripheral, for adjunctive fixation. All of the DePuy Duraloc Acetabular Cups are intended to be used with DePuy Duraloc polyethylene liners and locking rings to resurface the acetabular socket in cementless total hip replacement.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The DePuy Duraloc Acetabular Cups are substantially equivalent to the DePuy Duraloc Acetabular 1200 Cups cleared for both cementless fixation and cemented fixation (under the name Modified DePuy Acetabular Cup). All of the subject Duraloc Acetabular Cups and the Duraloc 1200 Cup are manufactured from Ti-6Al-4V alloy with a CP Titanium porous coating. All are available in numerous and varying outer diameters ranging from 38mm to 80mm and are designed to be used with the Duraloc polyethylene liners.
The only differences between the subject DePuy Duraloc Acetabular Cups and the Duraloc 1200 Cups are the addition of smaller outer diameter options with the Bantam cups; the number/and or placement of screw holes with the Bantam, Sector and Deep Profile Solution cups; the polished inner surface of the Polished Sector cups; and the full 180 degree hemispherical profile of the Full Profile Sector and Deep Profile Solution acetabular cups.