Intended Use

Second Opinion® CS is a computer aided detection ("CADe") software to aid dentists in the detection and segmentation of caries in periapical radiographs, designed for dental health professionals to review permanent teeth images in patients 12 years or older as a second reader.

Technology

Second Opinion® CS uses machine learning-based computer vision neural network algorithms to detect and segment caries on digital periapical radiographs. It processes images via an API linked to machine learning modules and displays results as overlays highlighting caries with segmentation showing lesion overlap with dentin and enamel.

Performance

The device's safety and effectiveness were demonstrated via standalone retrospective studies and multi-reader multi-case (MRMC) clinical trials showing improved caries detection sensitivity (>70%) and effective lesion segmentation compared to ground truth and predicate devices. Statistically significant improvement was observed with AI aided reading over unaided. The device met its primary endpoints with robust segmentation accuracy and manageable false positive rates.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    10/10/2024

    8 months
  • 2

    FDA Approval

    6/12/2025

Other devices from Pearl Inc.

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.