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Intended Use

The system is intended for the creation and viewing of digital images of scanned ThinPrep Pap test glass slides, aiding cervical cancer screening for atypical cells, cervical neoplasia, carcinoma, and other cytological classifications per The Bethesda System.

Technology

The system includes a digital slide imager that scans ThinPrep Pap test slides, an image management server for storing and managing images, a review station for image interpretation by cytologists/pathologists, and an AI algorithm using convolutional neural networks to identify objects of interest by analyzing whole slide images.

Performance

Multiple bench, analytical, and clinical studies were conducted. Analytical tests validated the imaging system's optical and scanning performance, color reproducibility, spatial resolution, and image quality. Clinical studies involving ~2000 slides across multiple sites showed that the AI system improves sensitivity for detecting LSIL+, ASC-H+, and HSIL+ lesions compared with manual and ThinPrep imaging system reviews, with a manageable decrease in specificity. User studies showed reduced cytologist workload without loss of diagnostic accuracy.

View FDA documentation

Device Timeline

  • 1

    Submission

    8/27/2021

    2 years, 5 months
  • 2

    FDA Approval

    1/31/2024

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