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    K Number
    K210068
    Device Name
    HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System
    Manufacturer
    Samsung Medison CO., LTD.
    Date Cleared
    2021-04-09

    (88 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K192505
    Why did this record match?
    Device Name :

    HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System

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

    The HS50 / HS60 Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.

    The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal(Cardiac) and peripheral vessel.

    If is intended for use by, or by the order of, and under the supervision of, a licensed physician who is qualified for direct use of medical devices. It can be used in hospitals, private practices, clinics and similar care environment for clinical diagnosis of patients.

    Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.

    Device Description

    The HS50 / HS60 are a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode. Color M mode. Anatomical mode. Color Doppler mode, Pulsed Wave (PW) Spectral Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, Power Doppler (PD) mode, ElastoScan Mode, 3D/4D/XI STIC imaging mode, Dual mode, Quad mode, Combined mode, Simultaneous mode and Zoom mode. The HS50 / HS60 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HS50 / HS60 have real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

    AI/ML Overview

    Based on the provided text, the device in question, the Samsung Medison HS50 / HS60 Diagnostic Ultrasound System, did not involve a clinical study with acceptance criteria and performance evaluation against a test set based on expert ground truth.

    The document explicitly states:
    "The proposed device HS50 / HS60 Ultrasound System did not require clinical studies to demonstrate substantial equivalence." (Page 6)

    Therefore, I cannot provide the detailed information requested in the prompt based on this submission. The submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of intended use, imaging capabilities, technological characteristics, and safety and effectiveness, supported by non-clinical testing against recognized standards.

    The new features mentioned (MV-Flow™, LumiFlow™, S-Detect™ for Thyroid, Slab 3D) are stated as being "migrated ... from predicates HERA W9/HERA W10 (K192319)" (Page 4). This implies that their performance was likely evaluated during the clearance of the HERA W9/W10 systems, and not as part of a new clinical study for the HS50/HS60.

    To directly answer your points where information is available/applicable:

    1. A table of acceptance criteria and the reported device performance: Not applicable, as no clinical study was performed. Performance was deemed "substantially equivalent" based on non-clinical data and comparison to predicate devices.
    2. Sample size used for the test set and the data provenance: Not applicable, as no clinical study was performed.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study was performed.
    4. Adjudication method for the test set: Not applicable, as no clinical study was performed.
    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: Not applicable, as no clinical study was performed. While S-Detect™ for Thyroid is mentioned, this submission does not detail an MRMC study for it.
    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as no clinical study was performed.
    7. The type of ground truth used: Not applicable, as no clinical study was performed.
    8. The sample size for the training set: Not applicable, as no clinical study information is provided.
    9. How the ground truth for the training set was established: Not applicable, as no clinical study information is provided.
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