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510(k) Data Aggregation

    K Number
    K040877
    Device Name
    ARTOSCAN C
    Manufacturer
    ESAOTE S.P.A.
    Date Cleared
    2004-05-04

    (29 days)

    Product Code
    LNH
    Regulation Number
    892.1000
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K032121,K010057
    Predicate For
    K092469
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    C-scan is a magnetic resonance (MR) system that produces transversal, sagittal and coronal and oblique crosssection images of the limbs and joints. It is intended for imaging portions of the arm, including the hand, wrist, forearm and elbow, but excluding the upper arm, and imaging portions of the leg, including the foot, ankle, call and knee, but excluding the thigh.

    C-scan MR images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

    Device Description

    The C-scan device is a magnetic resonance (MR) system. The changes performed on the C-scan device, with respect to the cleared version - Artoscan C K010057 -, are due to the improvement of the system performance. These modifications do not affect the intended use or alter the fundamental scientific technology of the device and are the following:

    1. Upgrading of the electronics.
    2. New pulse sequences.
    3. A new software release.
    4. Mobile installation.

    The system is composed of three main parts:

    1. Patient Positioning Seat
    2. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
    3. Electronics and Magnetic Unit
    AI/ML Overview

    The provided document is a 510(k) summary for the C-scan MR system, indicating it's a submission for modifications to an already cleared device (Artoscan C K010057) rather than a de novo submission. As such, the focus is on demonstrating substantial equivalence to the predicate device, not necessarily on entirely new clinical studies to prove effectiveness or diagnostic accuracy against specific acceptance criteria for a novel device.

    The "study" described here is a comparison of technical specifications and performance characteristics between the modified C-scan and the predicate Artoscan C, to show that the modifications do not alter the intended use and maintain or improve performance within the established safety and effectiveness profile of an MR diagnostic device.

    Here's an attempt to extract the requested information based on the provided text, acknowledging that some fields may not be directly applicable or explicitly stated in a 510(k) summary focused on technical equivalence for an MR system upgrade:

    Description of Acceptance Criteria and Study to Prove Device Meets Criteria

    The device under review, the C-scan MR System, is a modified version of the previously cleared Artoscan C (K010057). The acceptance criteria are implicitly based on demonstrating that the performance of the C-scan, with its upgraded electronics, new pulse sequences, new software, and mobile installation capability, is equivalent to or improved compared to the predicate device, without negatively affecting its intended use or fundamental scientific technology. The study presented is a technical comparison focusing on various system characteristics.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Feature/CharacteristicAcceptance Criteria (Implied: Equivalence/Improvement to Predicate)Reported Device Performance (C-scan)
    Pulse SequencesMaintained or enhanced range of pulse sequences.New sequences added: Spin Echo T1 3D (SET1_3D), Short TI Inversion Recovery 3D (STIR_3D), Short Time Inversion Recovery Gradient Echo 3D (GE_STIR_3D), and several High Resolution sequences (se_26, se_26_hf, se_18_he, tse_80, tme, ge_16). Existing sequences retained.
    Sequence ParametersMaintained or improved parameter ranges, especially for new sequences.SET1_3D: TR 60-5000 ms, TE 24 ms, min FOV 100 mm, FOV 3D 40-200 mm.STIR_3D: TR 150-5000 ms, TE 24 ms, TI 20-200 ms, min FOV 100 mm, FOV 3D 40-200 mm.GE_STIR_3D: TR 150-5000 ms, TE 16 ms, TI 20-200 ms, FA 90°, min FOV 100 mm, FOV 3D 40-200 mm.High Resolution Sequences: Fixed TEs (e.g., SE T1 at 26ms, GE at 16ms), increased max acquisition matrix to 512x512, ensuring best S/N for high resolution.
    Spatial ResolutionMaintained or improved spatial resolution.Improved: Up to 0.2 mm (nominal value), compared to Artoscan C's 0.4 mm. Achieved by increasing acquisition matrix (min pixel size = min FOV / max matrix size = 100x100mm / 512x512).
    Acquisition MatrixSufficient matrices for standard & high resolution imaging.2D FT: 192x128 to 256x256 (non-High Resolution); 192x128 to 512x512 (High Resolution).3D FT: 192x128 to 256x256, slice encoding from 24 to 128.
    Control System (Gradients)Modernized and capable control system.Digital electronic, DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM (upgrade from DSP SHARC 21062@40 MHz). Software ramp generation (from hardware).
    Magnetic CompensationRobust and technologically current compensation system."Open loop" control, digital elaboration of signal in separated channels (DC - 50/60 Hz - 16.6 Hz). Digital electronic, DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM (technological updating from microcontroller HC11).
    A/D Conversion (RF System)Technologically updated and efficient A/D conversion.For each channel: 3 MHz conversion, A/D converter 14 bit 20 MHz sampling (upgrade from 2 A/D converter 16 bit 78 kHz sampling). Digital demodulation and low-pass filter with wider bandwidth.
    Synthesizer (RF System)Improved frequency, amplitude, and phase modulation capabilities and stability.Digital, DSP SHARC 21161@100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM (upgrade from DSP SHARC 66 Mips). Improved resolutions (e.g., 28.4 µHz frequency, 4096 levels amplitude) and stability (< 1 ppm, < 8 x 10^-8 on 15 minutes).
    Central Processing UnitModern and powerful CPU for image processing.CPU Pentium IV 2.4 GHz or more, 1 GB Main memory, 512 KB Secondary cache (upgrade from Pentium III 700 MHz, 256 MB main memory, 256 MB secondary cache).
    Control ProcessorUpgraded control processor.DSP SHARC 21161 @ 100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM + 384 KB SSRAM (upgrade from DSP SHARC 21062 @ 40 MHz).
    Acquisition/Reconstruction ProcessorEnhanced processing power for image acquisition and reconstruction.DSP SHARC 21161 @ 100 MHz, 400 MFLOPs, 128 KB On-Chip SRAM + from 256 to 512 MB SDRAM + 1.28 MB SSRAM (upgrade from DSP SHARC 21060 @ 40 MHz).
    Hard Disk UnitIncreased storage capacity.At least 40 GB, 7200 rpm (upgrade from at least 20 GB).
    Image Reconstruction MatrixSupport for higher resolution images.2D: 128x128, 256x256, 512x512 (added 512x512).3D: 256x256x24 to 256x256x128 step 8 (modified lower bound for slice encoding).
    Type of InstallationFlexibility in installation.Permanent, Mobile (added mobile installation).
    Power ConsumptionCharacterization of power consumption.More precise characterization with slightly reduced consumption during quick magnet heating (950 VA vs 1100 VA).

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

    • This 510(k) summary primarily details technical specifications and comparisons to a predicate device. It does not describe a clinical test set in the traditional sense of patient data used for diagnostic accuracy assessment. The "study" here is a technical comparison report.
    • Therefore, there is no mention of a sample size or data provenance (country of origin, retrospective/prospective) for a clinical test set. The submission focuses on inherent device performance characteristics.

    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 test set is described, there's no mention of experts establishing ground truth for such a set. The validation is based on engineering and performance metrics compared to established standards for MR systems and the predicate device.

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

    • Not applicable. No clinical test set.

    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. The C-scan MR System is a diagnostic imaging device, not an AI-assisted diagnostic tool. There is no mention of AI or MRMC studies.

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

    • Not applicable. This is a hardware/software upgrade of an MR imaging system; it does not represent an "algorithm only" product for standalone performance assessment.

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

    • Not applicable in the clinical sense. The "ground truth" for this submission are the established technical specifications and performance characteristics of the predicate device (Artoscan C K010057) and general regulatory requirements for MR diagnostic devices. The modifications are assessed against these technical and performance benchmarks.

    8. The sample size for the training set:

    • Not applicable. This document does not describe a machine learning or AI algorithm where a "training set" would be used.

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

    • Not applicable, as there is no training set mentioned.
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