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510(k) Data Aggregation

    K Number
    K990153
    Device Name
    VIRGO MRI SYSTEM
    Date Cleared
    1999-10-08

    (262 days)

    Product Code
    Regulation Number
    892.1000
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.

    Device Description

    The Vaya MRI SYSTEM is functionally similar to most existing MRI systems. General specifications are as follows:
    Magnet Subsystem
    0.35 Telsa C-Shaped Compact Permanent Magnet Optimized Pole Design Homogeneity +/- 10 ppm with30 cm DSV Dimension 110cm x 160cm x 180cm Detachable Patient Table 2nd Detachable Patient Table Gradient Subsystem Strenath: 10mT/m Rise Time: 0.6ms Air Cooled RF Subsystem Quadrature Head Coil Quadrature Body/Spine Coil 3 Solenoid Coils for Extremities, Shoulder and C Spine Low Noise Preamplifier (0.5 dB Noise Figure) Digital RF Electronics Maximum Transmitter Power 5kW
    Computer System
    Host Computer: Dual Pentium CPU True Multi-tasking NT Environment All JAVA Language Programming RAM: 128MB Hard Disk: 2.1GB Image Capacity: 9000 256x256 1.7 GB WORM Archiving Remote System Maintenance Console Patient Registration Scanning Post-Processing & Image Enhancement (option) Display & Analysis Package Archiving User Defined Protocols User Specific Menus View Console (option) DICOM Compliant Laser Camera Interface Via 3M Protocol Laser Camera (option) CD Rewritable Drive (option) Protocols As Described on the Intended Use Page Site Requirements 5 Gauss Line 15" x 15" Maximum 3 Phase AC Power20kVA No Water Requirement

    AI/ML Overview

    This document is a 510(k) premarket notification for a new MRI system, the Virga™ MRI SYSTEM. It does not describe a study to prove that the device meets specific acceptance criteria in the way a clinical trial or performance validation study would for an AI/ML device.

    Instead, the submission focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (the AIRIS II M.R.I System by Hitachi Medical Systems America, K961876, K974212, K980691). The "acceptance criteria" in this context are the regulatory requirements for showing substantial equivalence, which primarily involve comparing technical characteristics, intended use, and performance to the predicate device.

    Therefore, many of the requested items (sample size, experts, ground truth type, training set details, MRMC study, standalone performance) are not applicable or not explicitly detailed in this type of regulatory submission, as it's not a study validating an AI algorithm's performance against clinical endpoints.

    However, I can extract the relevant information regarding the comparison to the predicate device and the implied "acceptance criteria" for substantial equivalence.


    1. Table of Acceptance Criteria and Reported Device Performance

    For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are effectively the characteristics of the predicate device, and the "reported device performance" is how the new device compares.

    FEATUREPredicate Device (Hitachi AIRIS II MRI System) "Acceptance Criteria"VIRGO MRI SYSTEM "Reported Performance"Substantial Equivalence Determination (SE?)
    Indications for UseNon-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.Non-invasive, non-ionizing diagnostic 2D & 3D imaging system for use on the head, spine, torso, abdomen and extremities.YES
    DesignOpen MRIOpen MRIYES
    Magnetic Field0.30 T (Telsa)0.35 T (Telsa)YES (Though different, this is a technical characteristic, not a direct performance metric that would invalidate equivalence without further clinical impact)
    Magnet TypePermanentPermanentYES
    OriginJapanCanadaYES (Administrative detail, not performance)
    ManufacturerHitachiMTI (MILLENNIUM TECHNOLOGY, INC.)YES (Administrative detail, not performance)
    Product Code90LNH90LNHYES
    K - NumberK961876, K974212, K980691PENDING (at time of submission)YES (Refers to the predicate's prior clearance)
    General ControlsComplies with Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.MILLENNIUM TECHNOLOGY, INC. intends to comply fully with the general controls authorized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.YES (Implied)
    Special ControlsComplies with § 1005.1 through 1005.24 and § 1005.25 for electronic products.MILLENNIUM TECHNOLOGY, INC. will comply with all special controls currently in effect.YES (Implied)
    Performance StandardsUtilizes various voluntary performance standards such as ASTM, ISO, QSR/CGMP, and in-house SOP standards.MILLENNIUM TECHNOLOGY, INC. will comply with all voluntary Performance Standards applicable to MRI systems (ASTM, ISO, QSR/CGMP, and in-house SOP standards).YES (Implied)

    Summary of "Study" to Prove Acceptance Criteria:

    The "study" here is the 510(k) Premarket Notification process itself, which aims to demonstrate substantial equivalence (SE) to a legally marketed predicate device. The core of this demonstration is the comparison table provided in the submission, highlighting the similarities in intended use, design, and technical specifications between the new device and the predicate.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not Applicable / Not Provided. This document does not describe a clinical performance study using a test set of patient data to evaluate the device's diagnostic accuracy or imaging quality. The comparison is based on the technical specifications and stated intended use of the device itself against a predicate device.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not Applicable / Not Provided. This document does not describe a study involving human readers or the establishment of ground truth for image interpretation.

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

    • Not Applicable / Not Provided. No adjudication method is described as there is no human reader study.

    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. This is a submission for an MRI system, not an AI-powered diagnostic algorithm. Therefore, no MRMC study or AI assistance is relevant or described.

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

    • No. This is not an AI algorithm. The device is a physical MRI system.

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

    • Not Applicable / Not Provided. For this type of 510(k) submission, the "ground truth" for showing substantial equivalence is primarily the technical specifications and regulatory clearance status of the predicate device. The new device is evaluated against these established characteristics of the predicate, not against clinical ground truth from patient data.

    8. The sample size for the training set

    • Not Applicable / Not Provided. There is no AI model or training set described.

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

    • Not Applicable / Not Provided. There is no AI model or training set described.

    In summary: K990153 is a 510(k) premarket notification for an MRI system, focusing on demonstrating substantial equivalence to a legally marketed predicate device (Hitachi AIRIS II). The "study" involves a feature-by-feature comparison of the new device to the predicate device to show that it is as safe and effective. It does not involve performance data from clinical trials or explicit validation against diagnostic accuracy metrics that would typically be described with acceptance criteria, sample sizes, and ground truth in the context of an AI/ML device or a novel diagnostic test.

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