(42 days)
The Pinnacle Duofix™ HA Acetabular Cup Prosthesis is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for revision of the previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques. The Pinnacle Duofix HA Acetabular Cup Prosthesis is indicated for cementless application.
The Pinnacle Duofix HA Acetabular Cup Prosthesis is a sintered, porous-coated (Porocoat®) hemispherical outer acetabular shell manufactured from titanium alloy (Ti-6Al-4V) with a thin layer of hydroxyapatite (HA) coating applied. The interior of the acetabular cup is designed with a groove and a taper for use with either an ultra-high molecular weight polyethylene (UHMWPE) or metal acetabular cup liner, which lock into the shell. Articulation occurs between the liner, and a femoral head with the appropriately sized diameter. The shells contain an apical threaded hole to allow the surgeon to attach the shell insertion instrument and grasp the shell during implantation. An optional titanium alloy (Ti-6Al-4V) apical hole plug is available to screw into the threaded apical hole of the shell. The plug is intended to occlude the apical hole in order to prevent particulate migration and provide polyethylene support. The Pinnacle Duofix HA Acetabular Cup Prosthesis is provided in shell diameter sizes 48mm through 66mm in both the "No Hole" (100 series) and the "Cluster Hole” (Sector series) configurations.
This document is a 510(k) Premarket Notification for the DePuy Pinnacle Duofix™ HA Acetabular Cup Prosthesis. It aims to demonstrate substantial equivalence to previously cleared devices (K000306 and K031495) rather than proving a specific medical device meets acceptance criteria through clinical studies.
Therefore, the information requested in your prompt for a study proving a device meets acceptance criteria, including specifics about an AI/human reader study, ground truth establishment, and sample sizes for training/test sets, is not present in this document.
This submission is focused on:
- Demonstrating equivalence: The primary purpose is to show that the modified device (manufacturing location, sterilization sites, and packaging change) is as safe and effective as previously cleared predicate devices.
- Non-clinical testing: The performance data listed are non-clinical (biological safety, sterilization validation, HA coating characterization).
- No clinical tests: The document explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence."
In summary, there is no study described in this document that proves the device meets explicit acceptance criteria through the types of clinical or AI performance studies your prompt asks about.
If you have a document discussing an AI/medical device performance study, please provide that, and I can attempt to extract the relevant information.
§ 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.