EDAX results.
Analysis of particulate (implant) debris is done by characterizing either proteinaceous (serum) or saline media by isolation treatment (either protein or acid digestion), and includes written reports and documentation attesting to:
1. Low Angle Laser Light Scattering (LALLS), also known as Laser Diffraction, analysis (0.1-700 microns) using a Microtrac X-100 to generate both number and volume analysis distributions with histogram graphs providing quantitative particle size.
2. Extensive Scanning Electron Microscopy (SEM) and Energy Dispersion Analysis by X-ray (EDAX) analysis of particles to determine qualitative particle shape. These images are provided in both photographic paper pictures and electronic format as results in binder. Also, a Number Based Analysis using SEM and image processing software may be performed to examine 10 low and 10 high power fields for generating another number distribution analysis.
Analysis includes written protocol, reports and data documentation ready for inclusion in regulatory submissions. All images are included with results, and all analyses meet and exceed ASTM 1877-05 (IDE) guidelines for particle analysis.
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Example results of debris characterized from proteinaceous milieu after isolation treatment:
LALLS characterization showing volume (left) and number (right) analyses.
SEM photograph at 6000 times magnification.
