(445 days)
General indications:
The MobileLink(0) Acetabular Cup System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures.
Indications:
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- Primary and secondary osteoarthritis
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- Rheumatoid arthritis
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- Correction of functional deformities
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- Avascular necrosis
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- Femoral neck fractures
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- Revision after implant loosening dependent on bone mass and quality
The MobileLink(8) Dual Mobility Insert is additionally indicated for:
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- Dislocation risks
The MobileLink(8) Acetabular Shells are intended for cementless fixation.
- Dislocation risks
The MobileLink® Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system. This 510k adds several system components to the MobileLink® Acetabular Cup System previously cleared in K182321.
Dual Mobility Inserts: The Dual Mobility Inserts are manufactured from CoCrMo alloy. They assemble by taper lock to any MobileLink® Acetabular Shell (either the PlasmaLink or TiCaP versions cleared in K182321) and mate with polyethylene Dual Mobility Liners (from the BiMobile System cleared in K171273 and K190535.
Shell/Insert Adapters ("face changers"): These are optional components that can be used as an interface between the MobileLink® Acetabular metal shells (either the PlasmaLink or TiCaP versions cleared in K182321) and the neutral and shouldered polyethylene inserts to adjust the center of rotation and anteversion angles. They are manufactured from Ti6Al4V alloy, and come in various designs: neutral, offset, offset with 10° inclination, and offset with 20° inclination. The neutral version assembles to the mating shell by taper lock only, while the other versions assemble by taper lock plus an assembly screw.
The provided document is a 510(k) summary for the LINK MobileLink® Acetabular Cup System. This document describes the device and its indications for use, but does not contain any information regarding specific acceptance criteria, device performance metrics, or study results that would allow for the completion of the requested table and detailed study description.
The "Performance Testing" section states that non-clinical performance testing and analysis were provided, including:
- Acetabular construct disassembly testing (Push-out, lever-out, torque out for all acetabular modular connections)
- Fretting/Corrosion testing
- Impingement testing
- Range of Motion analysis according to ISO 21535
- Biocompatibility evaluation
However, it does not report the acceptance criteria for these tests or the actual device performance values achieved. It only concludes that "The results of non-clinical performance testing demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent."
The document also explicitly states: "Clinical performance testing was not required to demonstrate the substantial equivalence of this device." This confirms that there was no study involving human subjects or a comparison of AI-assisted vs. non-AI assisted performance.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets, data provenance, number of experts, adjudication methods for ground truth, MRMC studies, or standalone performance.
- Details on ground truth types or training set information.
This information would typically be found in a more detailed technical report or study protocol, which are not included in this 510(k) summary.
§ 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.