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    K Number
    K172276
    Device Name
    Xario 200 Diagnostic Ultrasound System V6.0
    Manufacturer
    Toshiba Medical Systems Corporation
    Date Cleared
    2017-12-12

    (137 days)

    Product Code
    IYN,ITX,IYO
    Regulation Number
    892.1550
    Type
    Traditional
    Panel
    Radiology (RA)
    Reference & Predicate Devices
    K151451,K143027,K162155
    Why did this record match?
    Device Name :

    Xario 200 Diagnostic Ultrasound System V6.0

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

    The Diagnostic Ultrasound System Xario 200 Model TUS-X200 and Xario 200 Model TUS-X200S are indicated for the visualization of structures, and dynamic processes with the human body using ultrasound and to provide image information for diagnosis in the following clinical applications: fetal, abdominal, intra-operative(abdominal), laparoscopic, pediatric, small organs, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional), musculo-skeletal (superficial), cardiac adult, cardiac pediatric, trans-esoph(cardiac) and peripheral vessel.

    Device Description

    The Xario200 Model TUS-X200 and Model TUS-X200S are mobile diagnostic ultrasound systems. These systems are Track 3 devices that employ a wide array of probes including flat linear array, convex linear array, and sector array with frequency ranges between approximately 2 MHz to 12 MHz.

    AI/ML Overview

    The provided text describes modifications to an ultrasound system, the Xario 200 Diagnostic Ultrasound System V6.0, and states that these modifications do not change the intended use of the device. The modifications primarily involve the addition of new transducers and implementation of previously cleared software options. Therefore, the acceptance criteria and study information provided are primarily focused on demonstrating that the new transducers and software features perform as intended and are substantially equivalent to previously cleared devices or features.

    Acceptance Criteria and Reported Device Performance

    The document does not explicitly state quantitative acceptance criteria in a table format for the device's overall performance. Instead, it refers to the device performing "as intended" for the new features based on comparisons to predicate software/devices. The criteria for demonstrating safety and effectiveness likely included successfully fulfilling the intended use, maintaining image quality, and adhering to applicable medical device standards.

    Acceptance Criteria (Inferred)Reported Device Performance
    New transducers (PLU-1202BT and others for specific applications) function as intended.The various tables for each transducer (PSU-25BT, PSU-30BT, PSU-50BT, PSU-70BT, PVU-375BT, PVU-382BT, PVU-674BT, PVU-674MV, PVU-712BT, PVU-745BTF, PVU-745BTH, PVU-745BTV, PVU-681MVL, PVU-770ST, PVU-781VT, PVU-781VTE, PVL-715RS, PLU-704BT, PLU-1005BT, PLU-1202BT, PLU-1204BT, PET-512MC, PET-512MD, PET-805LA, PC-20M, PC-50M) are listed with their supported clinical applications and modes of operation, indicating suitability for their intended uses. For new indications, they are marked as 'N'.
    2D Wall Motion Tracking (2D WMT) performs as intended in comparison to predicate software.Clinical images of volunteers were obtained, and it was concluded that 2D WMT implemented on the subject device performs as intended in comparison to the predicate software. Specifically, it enables cardiac wall trace, local wall motion tracking, wall motion information analysis and display, cardiac volume measurement, and cardiac function analysis.
    Shear Wave feature performs as expected including measurement quantification accuracy and precision.Bench testing using an elasticity phantom demonstrated that the implementation of Shear Wave onto the subject device performed as intended, including measurement quantification accuracy and precision.
    The device maintains conformance with applicable standards.The device is designed and manufactured under the Quality System Regulations (21 CFR § 820 and ISO 13485 Standards). Conforms with applicable parts of IEC60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, AIUM RTD2-2004 Output Display, and ISO 10993-1 standards. Software Documentation for a Moderate Level of Concern was included as per FDA guidance.
    Software validation is successful.Successful completion of software validation is reported.

    Study Information

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

      • 2D Wall Motion Tracking: "Representative clinical images of volunteers were obtained." The exact sample size is not specified. The data provenance is implied to be clinical, but the country of origin is not detailed. Given the company is "Toshiba Medical Systems Corporation" in Japan and "Toshiba America Medical Systems, Inc" in the USA, it could be from either or both.
      • Shear Wave: "Bench testing was done using an elasticity phantom." This indicates a non-human, controlled setting. No specific sample size (e.g., number of phantoms or measurements) is provided.
      • Transducers: No specific test set size or data provenance is mentioned for the general performance of the new transducers beyond their listed clinical applications.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The document states "it was concluded" for 2D WMT and "As concluded in the study" for Shear Wave, implying expert assessment, but details about the number or qualifications of these experts are missing.

    3. Adjudication method for the test set: Not specified.

    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: Not explicitly stated. The document mentions 2D WMT "compared to predicate software", but this does not describe a comparative effectiveness study involving human readers with and without AI assistance for improved performance. The device itself is a diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool in the sense of a standalone AI algorithm for interpretation.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes bench testing for Shear Wave and clinical image evaluation for 2D WMT. While these tests evaluate the algorithm/feature's performance and output, it's not clear if a standalone algorithm-only performance assessment without any human review or interpretation of the output was conducted or reported. However, for an ultrasound system, the output (images, measurements) is inherently for human interpretation.

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

      • 2D Wall Motion Tracking: The phrase "Representative clinical images of volunteers were obtained" and "performs as intended" suggests a comparison against expected normal cardiac function and/or comparisons with the predicate device's output, likely adjudicated by clinical experts.
      • Shear Wave: "Bench testing using an elasticity phantom" implies a known, controlled physical property as ground truth for measurement accuracy and precision.

    7. The sample size for the training set: Not applicable and not mentioned. This document pertains to a diagnostic ultrasound system and its software features, not an AI/ML model that typically requires a training set.

    8. How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for an AI/ML model.

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