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510(k) Data Aggregation

    K Number
    K111776
    Device Name
    DELTAVIEW MODEL 2.1
    Manufacturer
    RIVERAIN MEDICAL GROUP,LLC
    Date Cleared
    2011-12-28

    (188 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K092363
    Why did this record match?
    Device Name :

    DELTAVIEW MODEL 2.1

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

    DeltaView is intended to generate a secondary residual image based on a current and prior chest x-ray image of the same patient, resulting in improved detection of lung nodules that have changed between the two examinations. The DeltaView image provides adjunctive information and is not a substitute for the original PA/AP image. This device is intended to be used by trained professionals, such as physicians and radiologists, on patients with risk of having lung nodules, and is not intended to be used on pediatric patients.

    Device Description

    DeltaView is a dedicated post-processing application which registers current and prior chest exams to provide an image that shows areas of change.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the DeltaView™ device based on the provided text:

    Acceptance Criteria and Device Performance

    Acceptance Criteria (Study Objective)Reported Device Performance
    Radiologist's results when using DeltaView images are superior to results when using standard prior and current AP/PA x-ray image pairs alone.Area under the Localized Receiver Operating Characteristic (LROC) curve (AUCLROC) increased from 0.477 (Unaided) to 0.536 (with DeltaView) (12.4% increase).
    The upper 95% confidence limit on the differences in the area under the DeltaView LROC curve (AUCDV) subtracted from the area under the Unaided LROC curve (AUCUA) is greater than or equal to 0.0.The text states "The research hypothesis indicating superiority was that the upper 95% confidence limit... is greater than or equal to 0.0," and the reported AUCLROC increase supports this.

    Study Details

    1. Sample sizes used for the test set and the data provenance:

      • The document does not explicitly state the sample size (number of cases or images) used for the test set.
      • The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • The document does not specify the number of experts or their qualifications for establishing ground truth.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

      • The document does not specify an adjudication method for the test set.

    4. 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 vs without AI assistance:

      • Yes, an MRMC reader study was done.
      • Effect size: The area under the LROC curve (AUCLROC) "increased from 0.477 to 0.536 (12.4%)" when radiologists were aided by DeltaView compared to unaided interpretation. This indicates a 12.4% improvement in the AUCLROC.

    5. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:

      • The document does not state that a standalone (algorithm-only) performance study was conducted. The study described focuses on human-in-the-loop performance with the device as an adjunct.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • The type of ground truth used is not explicitly stated. However, the study evaluated "the detection of actionable lung nodules," implying that a determination of the presence or change of such nodules constituted the ground truth.

    7. The sample size for the training set:

      • The document does not provide information on the sample size used for the training set.

    8. How the ground truth for the training set was established:

      • The document does not provide information on how the ground truth for the training set was established.
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