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510(k) Data Aggregation

    K Number
    K111098
    Device Name
    INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN
    Manufacturer
    IMAGING DYNAMICS COMPANY LTD.
    Date Cleared
    2011-05-27

    (37 days)

    Product Code
    MQB,MOB
    Regulation Number
    892.1680
    Type
    Special
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K071402,K102123,K090742
    Why did this record match?
    Reference Devices :

    K071402, K102123

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

    Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

    Device Description

    The innovaXion FP represents a modification of our own predicate K071402 X3C 1600 plus Digital Radiographic System. We now support the 510(k) cleared Samsung digital panel. The other radiographic equipment is identical to that supplied by Viztek in Ku 102123. We will market the product in four possible configurations:
    . innovaXion FP 1600 Plus
    innovaXion FP (flat panel as a retrofit package with Magellan FP software) .
    . Magellan (software)

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Stated)Reported Device Performance
    Substantial Equivalence to Predicate Devices"The results of clinical, bench, safety test, and software validation testing indicates that the new device is as safe and effective as our predicate device." "After analyzing risk analysis, software validation, safety testing data, and clinical images, it is the conclusion of IDC that the innovaXion FP software is as safe and, suite onlined predicate devices, have almost no technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate devices."
    Safety and Effectiveness comparable to predicate devices"This modified device has the same indications for use and technological characteristics as the predicate devices, in fact supplying the predicate devices in the end product. The only difference is adding a new panel (cleared sparely) ) and requisite software."
    Conformance to US Performance Standards"The modified device conforms to US Performance Standards and the hardware is CSA Listed to US Standards for softon for medical devices."
    UL listed to US Standards for safety (for digital receptor panels)"The digital receptor panels are UL listed to US Standards for safety for medical devices."

    2. Sample size used for the test set and the data provenance

    • Sample Size: Not explicitly stated. The document mentions "Clinical images were acquired" but does not give a specific number.
    • Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective in comparison, as "clinical images were acquired and compared to our predicate images," suggesting existing data from the predicate device was used for comparison.

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

    • This information is not provided in the document. The abstract does not detail the process of establishing ground truth for the clinical images used in the comparison.

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

    • This information is not provided in the document.

    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 vs without AI assistance

    • No, a multi-reader, multi-case comparative effectiveness study of the device with human readers was not done or described. The study focuses on comparing the new device's images to the predicate device's images.
    • This device is a digital X-ray system, not an AI-assisted diagnostic tool, so the concept of human readers improving with AI assistance is not applicable in this context.

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

    • The study described is a standalone performance comparison of the device itself (new digital panel and software) against a predicate device, based on acquired clinical images. It assesses image quality and output, not an algorithm's diagnostic performance. Therefore, in a sense, it's a "standalone" evaluation of the imaging system.

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

    • The document implies that the ground truth for the clinical images was established by the predicate images themselves serving as the reference. The new device's images were compared to these predicate images to determine if there were "no significant differences between them," implying the predicate images represented an acceptable standard. There's no mention of expert consensus, pathology, or outcomes data being used to establish a separate, independent ground truth.

    8. The sample size for the training set

    • This information is not applicable as the device is not an AI algorithm that requires a training set in the typical sense. It's a digital X-ray system.

    9. How the ground truth for the training set was established

    • This information is not applicable for the same reason as point 8.
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