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The MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These inages and/ or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

MAGNETOM Lumina and MAGNETOM Vida Fit with software syngo MR XA50A include new software compared to the predicate devices, MAGNETOM Vida Fit with software syngo MR XA20A (K192924) and MAGNETOM Lumina with syngo MR XA31A (K203443). This software and some hardware components are transferred from the reference device MAGNETOM Vida with software syngo MR XA50A (K213693) as well as an imaging feature from MAGNETOM Vida with software syngo MR XA11A (K181433). A high-level summary of the transferred hardware and software is provided below:

Hardware (Vida Fit only)
Transferred Hardware:

• The Nexaris Dockable Table is a new variant of the MR patient table which is used for intraoperative or interventional imaging. It enables the patient transfer between OR tables and the MR system without repositioning on the MR patient table and vice versa during interventional procedures and surgeries. Additionally, it can be used for diagnostic imaging.
• The Nexaris Head Frame holds up to two Ultra Flex Large 18 coils. It can be used for head imaging in combination with the Nexaris Dockable Table when the patient is positioned on the transfer board but not pinned in a head clamp.
• Transferred MaRS Computer
  Transferred Coil:
• The Nexaris Spine 36 is used in combination with and without transfer board for body imaging on the Nexaris Dockable Table.
  Transferred modifications for hardware:
• The Beat Sensor is a contact less method for generating cardiac triggers as an alternative to the already existing ECG or pulse triggers. It is based on a measurement of the modulation of a weak magnetic Pilot Tone, caused by conformation changes in conductive tissues.
  Software
  Transferred Features and Applications: Vida Fit only:
• SVS EDIT is a special variant of the SVS SE pulse sequence type, which acquires two different spectra (one with editing pulses on resonance, one with editing pulses off resonance) within a single sequence.
• BEAT FQ nav allows the user to make use of navigator echo based respiratory gating for flow imaging to acquire 4D flow data. Both navigator echo based respiratory gating as well as flow imaging are part of the predicate device already. New is merely the combination of both.
• The HASTE interactive pulse sequence type extends the existing HASTE pulse sequence type by offering the possibility to interactively change imaging parameters.
• GRE_WAVE is a special variant of the GRE pulse sequence type which allows larger acceleration factors, measuring one or two contrasts. GRE Wave results in higher signal-to-noise ratio for larger acceleration factors which can be leveraged to allow fast high-resolution 3D susceptibility-weighted imaging.
• The myExam Prostate Assist provides an assisted and quided workflow for prostate imaging. This automated workflow leads to higher reproducibility of slice angulation and coverage; this may support exams not having to be repeated.
• Iniector coupling is a software application that allows the connection of certain contrast agent injectors to the MR system for simplified, synchronized contrast injection and examination start.
  Lumina onlv:
• Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.
  Lumina and Vida Fit:
• Deep Resolve Swift Brain is a protocol for fast routine brain imaging primarily based on echo planar imaging (EPI) pulse sequences. Its main enablers are multi-shot (ms) EPI pulse sequence types and a deep learning-based image reconstruction.
• Deep Resolve Boost is a novel deep learning-based image reconstruction alqorithm for 2D TSE data, which reconstructs images from k-space raw-data.
• BLADE diffusion is a multi-shot imaging method based on TSE or TGSE (when EPI factor > 1) readout and a BLADE trajectory with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity and reduced T2 decay caused image blurring.
• HASTE diffusion (HASTE DIFF) is a single-shot imaging method based on TSE readout with diffusion preparation to enable diffusion weighted imaging with reduced sensitivity to B0 inhomogeneity.
  Transferred Modifications for Features and Applications:
  Vida Fit only:
• The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol.
• The 3D ASL sequence (tgse_asl) now provides relCBF maps, by implementing an additional M0 scan and performing the corresponding reconstruction method. It also provides BAT maps in multiple inversion time(multi-TI) imaging.
  Lumina and Vida Fit:
• Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
• Static Field Correction is a reconstruction option reducing susceptibilityinduced distortions and intensity variations.
• Deep Resolve Sharp is an interpolation algorithm which increases the perceived sharpness of the interpolated images. Functionality is available for different pulse sequence types. (Newly transferred to Vida Fit)
• Deep Resolve Gain is a reconstruction option which improves the SNR of the scanned imaqes. Functionality is available for different pulse sequence types. (Newly transferred to Vida Fit)
• The myExam Angio Advanced Assist provides an assisted and quided workflow for peripheral angiography examination using care bolus. The main advantage of this new workflow is a simplified and improved planning procedure of multi-station peripherical angiography measurements.
  Other transferred Modifications and / or Minor Changes
  Vida Fit only:
• Elastography-AddIn synchronizes settings between the Elastography sequence and the active driver.
• HASTE MoCo is an image-based motion correction in the average-dimension for the HASTE pulse sequence type.
• Coil independent pulse sequences remove the coil information from the pulse sequences and generate this information during run-time from automatic coil detection and localization.
• The Needle Intervention AddIn provides a user interface for workflow improvement of MR-quided needle interventions under real-time imaging conditions. It supports planning a needle trajectory, laser-based localization of the entry point as well as automatic slice positioning.
• The PhaseRev Dot Addin/Component supports the measurement workflow of the user by automatically flipping the direction of the phase encoding gradient.
• The adjustment mode "offcenter" triggers a transmitter adjustment method that is specialized for offcenter imaging. The transmitter adjustment determines the RF voltage that is required to excite a certain B1 field.
  Lumina and Vida Fit:
• TSE MoCo is an image-based motion correction in the average-dimension for the TSE pulse sequence type.
• MR Breast Biopsy is improved with an automatic fiducial detection.

The provided text primarily focuses on the substantial equivalence of the MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A to predicate devices. It does not include detailed information regarding specific acceptance criteria, device performance metrics, or the study design (e.g., sample sizes, expert qualifications, ground truth methods) that would typically be found in a clinical or performance study report.

Therefore, I cannot extract the requested information about acceptance criteria and the study proving the device meets them from the given document.

The document states:

• "No additional clinical tests were conducted to support substantial equivalence for the subject devices." (Page 9)
• The primary testing conducted was "Verification and validation" of transferred hardware and software features against "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices / 21 CFR §820.30" (Page 9).
• The conclusion is that "the results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate devices to which they have been compared." (Page 9).

This indicates that the submission relies on demonstrating equivalence to previously cleared devices through non-clinical verification and validation, rather than presenting a de novo performance study with specific acceptance criteria.

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Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These inages and/ or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

MAGNETOM Lumina with software syngo MR XA11B includes modified hardware and software compared to the predicate device, MAGNETOM Vida with syngo MR XA11A. A high level summary of the modified features is provided below:

Hardware
Modified Hardware

• -Gradient system with XK gradient engine (36/200): Reduction in GPA performance with unchanged hardware components
• -Cover: Adapted system design
• Tim [180x32] configuration: patient table with 180 simultaneous connectable coil elements

Software
New Features and Applications

• GOLiver: Set of optimized pulse sequences for fast and efficient imaging of the abdomen / liver. It is designed to provide consistent exam slots and to reduce the workload for the user in abdominal / liver MRI.
  Other Modifications and / or Minor Changes
• Turbo Suite marketing bundle: Turbo Suite is a marketing bundle of components for accelerated MR imaging offered for the MAGNETOM Lumina MR system.

Here's a breakdown of the acceptance criteria and study information for the MAGNETOM Lumina device, based on the provided document:

This document does not describe the specific acceptance criteria or a detailed clinical study demonstrating the device's performance in a way that typically includes metrics like sensitivity, specificity, or AUC, as would be expected for an AI/algorithm-based diagnostic tool. Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (MAGNETOM Vida) through non-clinical testing and adherence to recognized standards.

The "device" in question (MAGNETOM Lumina) is a Magnetic Resonance Diagnostic Device (MRDD), an MRI scanner, not an AI-powered diagnostic algorithm in the sense of providing specific disease detection or quantification with performance metrics. The new software feature "GOLiver" within the MAGNETOM Lumina is described as a set of optimized pulse sequences for imaging, designed to improve workflow, not an AI for diagnosis.

Therefore, many of the requested elements (like effect size of AI assistance, sample size for test set with ground truth, expert qualifications for ground truth, adjudication methods) are not applicable or not provided in the context of this 510(k) submission, which is for an MRI scanner itself.

However, I can extract information related to the closest aspects of acceptance criteria and testing that are present:

Acceptance Criteria and Device Performance for MAGNETOM Lumina

Given that the device is an MRI system (not an AI diagnostic algorithm), the acceptance criteria and performance evaluation are centered on safety, functionality, and image quality compared to a predicate device, rather than diagnostic accuracy metrics of an AI.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a number of patients or cases in the typical sense for an AI diagnostic study. The document mentions "Sample clinical images were taken for the hardware and software feature." This implies a set of images, but the quantity or characteristics of these images are not detailed.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The phrase "Sample clinical images were taken" suggests existing data, but further details are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable/not provided in the context of this submission. The "image quality assessment" was performed by implicitly qualified personnel comparing images, but there is no mention of a formal "ground truth" establishment by multiple experts with specific qualifications to evaluate diagnostic accuracy metrics typically derived from AI output.

4. Adjudication Method for the Test Set

• Not applicable/not provided. No formal adjudication method like 2+1 or 3+1 is mentioned, as this is not a study assessing diagnostic accuracy outcomes from an AI.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

• No MRMC comparative effectiveness study was explicitly done to evaluate how human readers improve with AI vs. without AI assistance. The document refers to "MAGNETOM Lumina" as an MRI system, not an AI-assisted diagnostic tool for interpretation. The software feature (GOLiver) is for optimized image acquisition, minimizing user workflow in abdominal/liver MRI, not for diagnostic assistance to human readers.

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

• Not applicable. The MAGNETOM Lumina is an MRI device, which acquires images for a human to interpret. It is not a standalone algorithm meant to provide a diagnosis without human interaction.

7. The Type of Ground Truth Used

• For the "Image quality assessment of the new set of pulse sequences (GOLiver)," the "ground truth" implicitly referred to was a comparison against the image quality produced by the pulse sequences of the predicate device. This is a comparison of technical image characteristics rather than a clinical ground truth (e.g., pathology, surgical findings, long-term outcomes for disease presence).

8. The Sample Size for the Training Set

• Not applicable/not provided. The device is an MRI scanner. While there is software, the document doesn't describe an AI model that underwent "training" in the machine learning sense with a specific training set to learn diagnostic patterns. The "GOLiver" feature is described as "optimized pulse sequences," which implies engineering and parameter tuning, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/not provided. As there's no mention of a traditional "training set" for an AI model, the concept of establishing ground truth for it is not relevant to this document.

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