510k Study Design for AI Diagnostic Algorithm

Hello,

We have developed an AI/Deep Learning algorithm for detecting a specific type of skin cancer in Pathology samples. We are preparing an application for 510k clearance for the software.

We have access to a lab that has 1,000 samples that we can test against, but we need someone to help us design the study.

The successful applicant should have prepared studies for prior 510k applications, and will be able to help guide us on trial parameters. We are programmers, but have limited experience with the statistical validity that the FDA requires.
About the recuiter
Member since Sep 9, 2017
Deshawn Cooke
from Maryland, United States

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