(118 days)
The Delta Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
· Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
- · Rheumatoid arthritis;
- · Post-traumatic arthritis,
- · Correction of functional deformity;
- · Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
- · Revisions in cases of good remaining bone stock;
- · Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only).
The Delta Acetabular System is intended for cementless use.
The Delta Multihole TT Pro Acetabular System consists of a Delta Multihole TT Pro cup, an acetabular liner and a modular femoral head. Bone screws can also be used to provide additional stability of the cup.
The Delta Multihole TT Pro cup is manufactured from titanium alloy; the Delta Multihole TT Pro liners are manufactured from cross-linked UHMWPE with Vitamin E and the femoral heads made of Biolox Delta ceramic or Cobalt Chrome Molybdenum alloy.
The design of shell is similar to the previously cleared sizes of Delta Multihole TT Pro Acetabular System (K191622) and the G7 Acetabular System (Biomet, Inc., K140669) devices. The acetabular liners, the Biolox Delta heads, the CoCrMo heads and the bone screws are the same as those cleared in K182099. The Multihole TT Pro cup has a hemispherical design and provides holes in cranial and caudal aspects of the cup to provide additional cup stability by means of fixation screws. The Multihole TT Pro cup is coupled with a Delta TT Pro acetabular liner that is available in neutral, protruded and high wall versions.
This document is a 510(k) summary for the Limacorporate S.P.A. Delta Multihole TT Pro Acetabular System. It details the device, its intended use, and substantial equivalence to predicate devices, but does not describe acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot extract the requested information from the provided text. The document explicitly states:
- Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Multihole TT Pro Acetabular System to the predicate devices.
This means there is no clinical study described in this document that would include acceptance criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies related to AI device performance. The information provided is for a total hip arthroplasty system, a physical medical device, not an AI or software as a medical device.
If you intended to ask about the acceptance criteria and study for a different type of device (e.g., an AI/ML powered diagnostic device), please provide the relevant document.
§ 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.