(29 days)
This device is intended for use in total hip arthroplasty. The device is intended for uncemented, biological fixation only in cases of:
- Notably impaired hip joints due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
- Previously failed hip surgery.
- Fractures of the femoral neck or head.
- Avascular necrosis of the femoral head.
- Congenital dysplasia or other structural abnormalities where stock exists to properly seat the prosthesis.
The proposed subject device Escalade Legend® Acetabular Shell is a line extension to the Escalade Acetabular Cup System (K103384). The Escalade Acetabular Cup System is a modular system intended for the replacement of the natural articular surface of the hip replacement surgery. The system consists of acetabular shells, liners, bone screws, apical screw hole cover, and femoral heads.
The Escalade Legend® Acetabular Shells are hemispherical in shape and are designed for press-fit, cementless, surgical applications. The subject device differs from the shell in K103384 device in the use of sintered titanium beads instead of titanium plasma spray for bone fixation.
The provided document is a 510(k) summary for the Escalade Legend® Acetabular Shell. It describes a medical device and its equivalence to a predicate device. The information provided does not include the specifics of acceptance criteria for software performance or a study proving a device meets such criteria for AI/software.
The document discusses non-clinical testing for certain physical characteristics of the device, but this is not related to software performance or AI.
Therefore, I cannot extract the requested information concerning acceptance criteria for device performance related to AI/software, as the document pertains to a physical medical implant (an acetabular shell) and its material and mechanical properties, not an AI or software-based device.
Specifically, there is no mention of:
- A table of acceptance criteria and reported device performance for software.
- Sample sizes for test sets or data provenance for software.
- Number of experts or their qualifications for establishing ground truth for software.
- Adjudication methods for software test sets.
- Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
- Standalone performance studies for an algorithm.
- Type of ground truth for software performance.
- Sample size for the training set of an AI.
- How ground truth for a training set was established for AI.
The document states: "No clinical studies were performed." and the non-clinical testing performed is for material and connecting strength properties.
§ 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.