Statistics for 510(k) Submissions


For most non-statisticians, reviewing the statistical sections of a 510(k) can be a taunting task. This paper does not aim to replace a statistician, but rather to familiarize the reader with some common statistical techniques used for 510(k) submissions.

This white paper includes discussion of Summary Statistics, Graphical Methods, Statistical Terms and more. It will help you:

  • Understand P-value
  • Learn Best Practices for Sample Selection
  • Use Confidence Intervals and Tolerance Intervals
  • Understand Equivalence and TOST
  • Learn about Non-Inferiority and Contingency Tables
  • Identify Software Tools available for these Tests and Analyses

Download contains:

  • Statistics for 510(k) Submissions White Paper (.pdf, 5 pages)
SKU: WPS-01 Category: