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    K Number
    K121963
    Device Name
    PLANMED NUANCE DIGIGUIDE
    Manufacturer
    PLANMED OY
    Date Cleared
    2012-11-21

    (139 days)

    Product Code
    MUE
    Regulation Number
    892.1715
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K021945
    Why did this record match?
    Device Name :

    PLANMED NUANCE DIGIGUIDE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Planmed Nuance DigiGuide is an optional system for Stereotactic Biopsy. It consists of a needle guidance unit attached to Planned Nuance or Planmed Nuance Excel digital mammography X-ray units and DigiGuide software module for Nuance Manager 3 acquisition software.

    The system is used for needle sampling of women's breast tissues for examination. The use of Planmed Nuance DigiGuide is allowed only under supervision of a health care professional.

    Device Description

    Planmed Nuance DigiGuide is a digital biopsy imaging system. This system is compatible with Planmed Nuance and Planmed Nuance Excel FFDM X-ray units. .

    The Planmed Nuance DigiGuide system consists of the FFDM X-ray unit (Planmed Nuance or Planmed Nuance Excel) that is equipped with the needle guidance unit and the acquisition workstation (AWS), including a personal computer with the Nuance Manager 3 software, which is used for acquiring mammographic images, determining the lesion coordinates, and taking the biopsy.

    AI/ML Overview

    This document describes the Planmed Nuance DigiGuide, a stereotactic biopsy system for Full Field Digital Mammography (FFDM). The submission is a 510(k) premarket notification (K121963) to the FDA.

    1. Table of Acceptance Criteria and Reported Device Performance

    The FDA submission for the Planmed Nuance DigiGuide does not explicitly define quantitative acceptance criteria for its performance. Instead, it relies on a comparison to a predicate device and qualitative assessments.

    CriteriaAcceptanceReported Device Performance
    Substantial Equivalence to Predicate DeviceDevice functions similarly, has similar design and composition.Considered similar in design, composition, and function to K021945 Planmed Sophie & Sophie Classic (with Digispot and Cytoguide) = Planmed DigiGuide. The biopsy procedure, needle guidance unit, and control are the same.
    Image Quality (Clinical Test)At least equal to the old system (predicate device).The image quality scored was at least equal to the old system.
    Accuracy and Reliability (Clinical Test)Accurate and reliable in clinical use.The new Planmed Nuance DigiGuide system was accurate and reliable in clinical use.
    Compliance with Set Specifications (Nonclinical)Compliance with set specifications.Nonclinical verification tests at the factory and accuracy tests by a 3rd party show compliance with set specifications.
    Workflow Improvement (Implicit)Faster and more accurate procedure due to technical differences.Removes the need to move the detector between stereo exposures and mark the reference in images, "making the procedure faster and more accurate."

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: 20 stereotactic biopsies.
    • Data Provenance: Conducted at a mammography screening facility. The information does not explicitly state the country of origin, but the manufacturer is based in Finland. It is a prospective clinical test.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    The document does not specify the number of experts or their qualifications used to establish ground truth for the 20 stereotactic biopsies. It mentions "a mammography screening facility, which already had long experience in using the previous Planmed DigiGuide system," implying experienced healthcare professionals were involved in the clinical evaluation.

    4. Adjudication Method for the Test Set

    The document does not explicitly state the adjudication method (e.g., 2+1, 3+1, none) used for the clinical test set. It describes the "end result" of the comparison study, suggesting a consensus or evaluation process by the clinical site's staff.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI versus without AI assistance?

    No MRMC comparative effectiveness study was mentioned. This device is a hardware system for biopsy guidance, not an AI-assisted diagnostic tool for human readers. The clinical test was a comparison of the new hardware system to its predicate, focusing on image quality, accuracy, and reliability during the biopsy procedure.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done?

    This is not applicable as the Planmed Nuance DigiGuide is a hardware system for biopsy guidance, requiring human operation. It is not an algorithm with standalone performance.

    7. The Type of Ground Truth Used

    For the clinical study, the "ground truth" was likely defined by the success and accuracy of the biopsy procedure itself, including successful tissue acquisition and the clinical assessment of the system's performance (image quality, accuracy, reliability) by experienced users at the mammography screening facility. It is implied to be expert clinical assessment rather than pathology or outcomes data specifically. The statement "The new Planmed Nuance DigiGuide system was accurate and reliable in clinical use" suggests a clinical consensus on performance.

    8. The Sample Size for the Training Set

    No training set is mentioned as this device is a hardware system, not a machine learning algorithm requiring a separate training set.

    9. How the Ground Truth for the Training Set Was Established

    Not applicable, as there is no training set for this device.

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