ContourQA is a powerful software tool designed to automatically assess AI performance across diverse imaging modalities and generate a report conforming to FDA requirements.

Effortless Experiment Documentation

• Built-in annotation features log every user action, ensuring full traceability and transparency.
• Automatically captures and documents detailed experiment workflows, including annotation processes, data specifications, algorithm descriptions, and performance results.

Automatic AI Metric Calculation

• Calculates evaluation metrics for AI detection and segmentation against the reference standard, delivering consistent and accurate results with clear insights to validate your AI solutions with confidence.

Advanced Statistical Analysis

• Offers rigorous statistical analysis to demonstrate substantial equivalence, providing strong evidence to support regulatory requirements.

Auto-generated AI Evaluation Report

• Generates a comprehensive report that conforms to the FDA requirements and includes experiment documentation, metrics and statistical analysis.
• This streamlined report greatly simplifies FDA 510(k) submission preparation, ensuring that all necessary documentation is organized and easily accessible.

Our data service includes compiling and preparing training and validation data with automated quality control to accelerate the development of your AI tool.

Data Source

• Leverage our extensive network of data providers to access tailored datasets that meet your specific requirements.
• We ensure high-quality, diverse data to support robust training and validation, helping to speed up the development process with confidence.

Expert Annotation

• We provide expert annotation services to create accurate and reliable reference standards, offering a solid foundation for effectively training and evaluating your AI tool’s performance.

Quality Control

• We manage the preprocessing and formatting of datasets using AI-based algorithms to ensure compatibility with your device and compliance with regulatory standards, streamlining both the training and validation processes.

We offer expert technical support to optimize the development of your AI tool.

AI Algorithm Optimization

• Our experts assist in fine-tuning and optimizing AI algorithms, ensuring maximum accuracy, efficiency, and scalability to meet your tool’s specific requirements.

Performance Evaluation

• We provide in-depth analysis and benchmarking of your AI tool’s performance, identifying areas for improvement and ensuring reliable, high-quality results.

Integration Support

• Our team delivers seamless integration support, ensuring that your AI tool easily fits within existing systems and clinical workflows for smooth deployment and operation.

With extensive experience in FDA 510(k) submissions, we provide expert guidance to ensure an efficient approval process with minimal roadblocks.

Regulatory Compliance

• Comprehensive support to ensure your AI tool meets all FDA regulatory requirements, including adherence to relevant guidelines, standards, and documentation expectations.

Content Completeness

• Assistance in preparing and reviewing submission content, ensuring completeness and accuracy across all necessary components such as device descriptions, performance data, validation results, risk assessments, and cybersecurity.

Submission Strategy

• Tailored strategies to streamline the submission process, including pre-submission consultations, addressing FDA feedback, and effectively navigating regulatory pathways.