(12 days)
Indication: for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following:
- Non-inflammatory degenerative joint disease including: osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia,
- Inflammatory degenerative joint disease including rheumatoid arthritis;
- Correction of functional deformity;
- Revision procedures where other treatments or devices have failed; and, treatment of nonunion, femoral neck fractures of the proximal femur with head Involvement that are unmanageable using other techniques.
The Avalon cup is manufactured from Titanium 6AL 4V Eli (ASTM F136). The Avalon Cup is porous coated with commercial pure (CP) titanium sintered beads (ASTM F67) to promote fixation. The Avalon Cup is a low profile cup available in three versions: [No-hole], [Three hole], and a [Multi-hole]. The holes are to allow for added fixation with bone screws. The Avalon Cup's outer geometry consists of a 14° flared rim and 8 external cutouts, which are machined into the peripheral exterior of the cup.
The provided document, K022711 for the Avalon Cup System, is a 510(k) premarket notification for an orthopedic implant. It primarily focuses on demonstrating substantial equivalence to a previously cleared device. Therefore, it does not contain the detailed information requested regarding specific acceptance criteria, a dedicated study proving performance against those criteria, or an AI/algorithm-related evaluation.
The document states:
"The proposed device modification has been tested and meets and exceeds the requirements provided in the Draft Guidance Document for Testing Orthopedic Implants With Modified Metallic Surfaces Apposing Bone Or Bone Cement."
and
"The Avalon Acetabular cup system demonstrated adequate performance in design control activities."
However, it does not provide the acceptance criteria, the specific study results, or any of the detailed information about sample size, ground truth, expert involvement, or AI performance as requested. The "modification" is a "line extension" to add a sintered beaded coated option, which is explicitly stated to have no changes to any other aspect of the cup. The basis of substantial equivalence relies on the new device being "identical (except for sintering process)" to the previously cleared device.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, and AI evaluation based on the information provided in this 510(k) summary. The document is about demonstrating equivalence for a minor material change, not about proving device performance against detailed statistical acceptance criteria or evaluating an algorithm.
§ 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.