(221 days)
- Non-inflammatory degenerative ioint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity 4) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) Revision of previously failed total hip arthroplasty. Cemented and Uncemented Applications.
Biomet Manufacturing Corp. is modifying the manufacturing process of UHMWPE used in the fabrication of polyethylene acetabular components. The modified manufacturing process results in a higher cross-linked polyethylene, that Biomet will herein refer to as ArComXL™.
The provided document describes the ArComXL™ Polyethylene Liners and studies conducted to demonstrate their performance compared to a predicate device. The information is extracted from a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than defining explicit "acceptance criteria" in the same way one might for a new, novel product with performance goals.
However, we can infer the acceptance criteria from the reported performance improvements over the predicate device. The studies are standalone (algorithm only, no human-in-the-loop performance is relevant here as it's a material science evaluation). The ground truth is based on physical material testing and established ASTM standards, not expert consensus or clinical outcomes.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
Note: "Acceptance Criteria" are inferred as improved performance over the predicate device, as this is a 510(k) submission for a modification to an existing device. The goal is to show the new device is "substantially equivalent" or better.
| Category | Acceptance Criteria (Inferred from Predicate Performance Baseline) | Reported Device Performance (ArComXL™) |
|---|---|---|
| Hip Simulator Wear | Volumetric wear rate ≤ predicate (65.8 mm³/10⁶ cycles) | 47% reduction (34.9 mm³/10⁶ cycles) vs. predicate |
| Abrasive Hip Wear | Volumetric wear rate ≤ predicate (309.0 mm³/10⁶ cycles) | 64% reduction (109.8 mm³/10⁶ cycles) vs. predicate |
| Free Radicals | Number of free radicals ≤ predicate (3.82 x 10¹⁵ spins/g) | 94% reduction (0.22 x 10¹⁵ spins/g) vs. predicate |
| Oxidative Stability | Oxidation index ≤ predicate (>=1.1 at 1mm depth) after aging | No measurable oxidation (index |
§ 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.