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510(k) Data Aggregation

    K Number
    K163328
    Device Name
    Planmed Clarity
    Manufacturer
    Planmed Oy
    Date Cleared
    2017-12-28

    (395 days)

    Product Code
    MUE
    Regulation Number
    892.1715
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K111361
    Predicate For
    K192317,K202822
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Planmed Clarity 2D mammography unit acquires digital 2D mammographic images. The Planned Clarity 2D system is intended to be used for screening and diagnosis of breast cancer. The Planmed Clarity system may also be used for additional diagnostic workup of the breast.

    Device Description

    The Planmed Clarity is a Full Field Digital Mammography (FFDM) system for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Planmed Clarity utilizes an amorphous silicon based digital image receptor to capture digital images. The receptor directly converts the incoming X-ray photons to digital image data. The workflow with Planmed Clarity is controlled from the acquisition workstation and Planmed Clarity Manager image acquisition and communications software. The patient information is entered manually or received from the hospital. radiology, or mammography information systems (HIS, RIS, or MIS, respectively), as a format of modality worklist. Subsequently, the images are acquired, processed, and displayed for preview. After initial evaluation by the user, the images are either printed or transferred for soft-copy review.

    AI/ML Overview

    The provided text describes the 510(k) submission for the Planmed Clarity Full Field Digital Mammography (FFDM) system. However, it does not contain information about acceptance criteria or a study proving the device meets those acceptance criteria for an AI/algorithm-based diagnostic device.

    The document outlines the testing and performance data for the mammography imaging system itself, focusing on its physical and technical capabilities compared to a predicate device. This includes:

    • Biocompatibility testing
    • Electrical safety and electromagnetic compatibility (EMC)
    • Software Verification and Validation Testing (for the system's software, not an AI algorithm)
    • Physical laboratory testing (sensitometric response, spatial resolution, noise analysis, dynamic range, repeated exposures, AEC performance, phantom tests, patient radiation dose, breast compression system)
    • Clinical image evaluation by an MQSA certified radiologist to assess overall image quality.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance specifically for an AI/algorithm.
    2. Sample size used for the test set and data provenance for an AI/algorithm study.
    3. Number of experts and their qualifications for AI ground truth establishment.
    4. Adjudication method for AI test set.
    5. MRMC comparative effectiveness study results for AI assistance.
    6. Standalone performance for an AI algorithm.
    7. Type of ground truth for AI.
    8. Sample size for AI training set.
    9. Ground truth establishment method for AI training set.

    The document confirms the Planmed Clarity is a mammography imaging system, not an AI diagnostic device. The "Software Verification and Validation Testing" refers to the operational software of the mammography unit, not a separate AI diagnostic algorithm subject to specific diagnostic performance acceptance criteria. The clinical image evaluation mentioned is for the image quality of the output of the imaging system and not for the diagnostic performance of an AI model using those images.

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