(82 days)
The Apex Hole Eliminator PSis a threaded plug intended to close the apical hole of the Duraloo® series two-piece acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement. It can be used after insertion of the acetabular cup in a cementless technique once the cup is well seated to prevent movement of blood or particles from behind the shell through the hole or it can be placed prior to insertion of the cup if the cup is being cemented into place to prevent cement from coming through the apical hole. The Apex Hole Eliminator PS also provides support of the polyethylene liner utilized in the metal shell, assuring full, congruent, uninterrupted support of the liner within the shell, and eliminating the potential of cold flow of the liner into the apical hole of the metal shell.
The Apex Hole Eliminator PSis a threaded plug intended to close the apical hole of the Duraloo® series two-piece acetabular cups. It is intended for use in Duraloc cups implanted with or without bone cement. It can be used after insertion of the acetabular cup in a cementless technique once the cup is well seated to prevent movement of blood or particles from behind the shell through the hole or it can be placed prior to insertion of the cup if the cup is being cemented into place to prevent cement from coming through the apical hole. The Apex Hole Eliminator PS also provides support of the polyethylene liner utilized in the metal shell, assuring full, congruent, uninterrupted support of the liner within the shell, and eliminating the potential of cold flow of the liner into the apical hole of the metal shell.
This document describes a medical device called the "Apex Hole Eliminator PS," which is a threaded plug used with acetabular cups in hip prostheses. The document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.
Therefore, I cannot provide the requested table and study details. This appears to be a 510(k) summary for a device seeking substantial equivalence, and such summaries often focus on comparisons to predicate devices rather than reporting on specific performance studies with quantitative acceptance criteria for new, novel functions.
The information provided confirms:
- Device Name: Apex Hole Eliminator PS
- Intended Use: To close the apical hole of Duraloc® series two-piece acetabular cups, preventing blood/particle movement or cement intrusion, and providing support for the polyethylene liner.
- Basis of Substantial Equivalence: Comparison to DePuy Duraloc® 100C Acetabular Cup and Wright Medical Interseal™ Acetabular Components based on similar designs and intended use.
- Key Differences (from predicate): Material (Ti-6AL-4V vs. Co-Cr-Mo) and threading design.
To answer your specific questions, information regarding acceptance criteria, device performance metrics, study design, sample sizes, expert involvement, ground truth, or MRMC studies is entirely absent from the provided text.
§ 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.