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510(k) Data Aggregation

    K Number
    K213523
    Device Name
    X-CUBE i8, X-CUBE i9
    Manufacturer
    Alpinion Medical Systems Co., Ltd.
    Date Cleared
    2022-01-28

    (86 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K182594
    Why did this record match?
    Reference Devices :

    K211300 X-CUBE 90, K181277 E-CUBE 12, K150773 E-CUBE 15, K181617 E-CUBE 8, K161439 E-CUBE 11

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

    The X-CUBE i8, X-CUBE i9 diagnostic ultrasound systems are intended for use by, or by the order the supervision of, a licensed physician who is qualified for the evaluation of soft tissue and blood flow in the clinical applications of Fetal; Abdominal(renal & GYN/pelvic); Pediatric; Small Organ(breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Trans-raginal; Musculo-skeletal(Conventional); Musculo-skeletal(Superficial); Cardiac(adult& pediatric); Trans-esoph. (Cardiac); Peripheral Vessel(PV); and Urology(including prostate).

    And, in the imaging modes of 2D(B) mode; Harmonic mode(HAR); M mode; Anatomical M mode; Color Flow Doppler(CF) Mode; Power Doppler(PD) Mode; Directional PD mode; Pulsed Wave Doppler(PWD) Mode; Continuous Wave Doppler(CWD) Mode; High PRF Doppler mode; Tissue Doppler Imaging(TDI) Mode.

    The X-CUBE i8. X-CUBE i9 are intended to be used in a hospital or medical clinic.

    Device Description

    X-CUBE i8 and X-CUBE i9 products are an ultrasound imaging system for medical diagnosis. This system platform provides optimal patient diagnosis workflow with the wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.

    Signal Mode:
    2D(B) mode, Harmonic mode (HAR), M mode, Color M mode, Anatomical M mode, Color Flow Doppler(CF) Mode, Power Doppler(PD) Mode, Directional PD mode, Pulsed Wave Doppler(PWD) Mode, Continuous Wave Doppler(CWD) Mode, High PRF Doppler mode, Tissue Doppler Imaging(TDI) Mode

    Combination Mode:
    B/Color Doppler, B/PWD, B/Color Doppler/PWD

    Acoustic output track: Track 3

    AI/ML Overview

    This document is a 510(k) premarket notification for an ultrasound imaging system. It demonstrates substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific performance acceptance criteria for an AI/ML-driven medical device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details for an AI/ML system.

    The "Summary of Non-Clinical Tests" and "Summary of Clinical Tests" sections explicitly state:

    • Non-Clinical: "X-CUBE i8 and X-CUBE i9 have been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards." This refers to general device safety and performance based on standards like IEC 60601-1, NEMA UD 2, etc., not AI/ML performance.
    • Clinical: "The subject of this premarket submission, X-CUBE i8 and X-CUBE i9, did not require clinical studies to support substantial equivalence." This means no human-in-the-loop or standalone clinical AI/ML performance studies were conducted or presented for this submission.

    Therefore, I cannot fulfill your request to extract the specific information about acceptance criteria and a study proving AI/ML device performance from the provided document, as the document does not contain this type of information.

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