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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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