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The MAGNETOM system is indicated for use as a magnetic resonance diagnostic 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 images 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.

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.

The subject device, MAGNETOM Avanto Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Avanto Fit with syngo MR XA50A (K220151).

A high-level summary of the new and modified hardware and software is provided below:

For MAGNETOM Avanto Fit with syngo MR XA70:

Hardware

New Hardware:
myExam 3D Camera
BM Head/Neck 20

Modified Hardware:
Sanaflex (cushions for patient positioning)

Software

New Features and Applications:
myExam Autopilot Brain
myExam Autopilot Knee
3D Whole Heart
HASTE_interactive
GRE_PC
Open Recon
Deep Resolve Gain
Fleet Reference Scan
Physio logging
complex averaging
AutoMate Cardiac
Ghost Reduction
BLADE diffusion
Beat Sensor
Deep Resolve Sharp
Deep Resolve Boost and Deep Resolve Boost (TSE)
Deep Resolve Boost HASTE
Deep Resolve Boost EPI Diffusion

Modified Features and Applications:
SPACE improvement (high band)
SPACE improvement (incr grad)
Brain Assist
Eco power mode
myExam Angio Advanced Assist (Test Bolus)

The subject device, MAGNETOM Skyra Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Skyra Fit with syngo MR XA50A (K220589).

A high-level summary of the new and modified hardware and software is provided below:

For MAGNETOM Skyra Fit with syngo MR XA70:

Hardware

New Hardware:
myExam 3D Camera

Modified Hardware:
Sanaflex (cushions for patient positioning)

Software

New Features and Applications:
Beat Sensor
HASTE_interactive
GRE_PC
3D Whole Heart
Deep Resolve Gain
Open Recon
Ghost Reduction
Fleet Reference Scan
BLADE diffusion
HASTE diffusion
Physio logging
complex averaging
Deep Resolve Swift Brain
Deep Resolve Sharp
Deep Resolve Boost and Deep Resolve Boost (TSE)
Deep Resolve Boost HASTE
Deep Resolve Boost EPI Diffusion
AutoMate Cardiac
SVS_EDIT

Modified Features and Applications:
SPACE improvement (high band)
SPACE improvement (incr grad)
Brain Assist
Eco power mode
myExam Angio Advanced Assist (Test Bolus)

The subject device, MAGNETOM Sola Fit with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola Fit with syngo MR XA51A (K221733).

A high-level summary of the new and modified hardware and software is provided below:

For MAGNETOM Sola Fit with syngo MR XA70:

Hardware

New Hardware:
myExam 3D Camera

Modified Hardware:
Sanaflex (cushions for patient positioning)

Software

New Features and Applications:
GRE_PC
3D Whole Heart
Ghost Reduction
Fleet Reference Scan
BLADE diffusion
Physio logging
Open Recon
Complex averaging
Deep Resolve Sharp
Deep Resolve Boost and Deep Resolve Boost (TSE)
Deep Resolve Boost HASTE
Deep Resolve Boost EPI Diffusion
AutoMate Cardiac
Implant suite

Modified Features and Applications:
SPACE improvement (high band)
SPACE improvement (incr grad)
Brain Assist
Eco power mode

The subject device, MAGNETOM Viato.Mobile with software syngo MR XA70A, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Viato.Mobile with syngo MR XA51A (K240608).

A high-level summary of the new and modified hardware and software is provided below:

For MAGNETOM Viato.Mobile with syngo MR XA70:

Hardware

New Hardware:
n.a.

Modified Hardware:
Sanaflex (cushions for patient positioning)

Software

New Features and Applications:
GRE_PC
3D Whole Heart
Ghost Reduction
Fleet Reference Scan
BLADE diffusion
Physio logging
Open Recon
Complex averaging
Deep Resolve Sharp
Deep Resolve Boost and Deep Resolve Boost (TSE)
Deep Resolve Boost HASTE
Deep Resolve Boost EPI Diffusion
AutoMate Cardiac
Implant suite

Modified Features and Applications:
SPACE improvement (high band)
SPACE improvement (incr grad)
Brain Assist
Eco power mode

Furthermore, the following minor updates and changes were conducted for the subject devices:

Low SAR Protocol minor update (for all subject devices but MAGNETOM Skyra Fit): the goal of the SAR adaptive protocols was to be able to perform knee, spine, heart and brain examinations with 50% of the max allowed SAR values in normal mode for head and whole-body SAR. The SAR reduction was achieved by parameter adaptations like Flip angle, TR, RF Pulse Type, Turbo Factor, concatenations. For cardiac clinically accepted alternative imaging contrasts are used (submitted with K232494).

Implementation of image sorting prepare for PACS (submitted with K231560).

Implementation of improved DICOM color support (submitted with K232494).

Needle intervention AddIn was added all subject device (submitted with K232494).

Inline Image Filter switchable for users: in the subject device, users have the ability to switch the "Inline image filter" (implicite Filter) on or off. This filter is an image-based filter that can be applied to specific pulse sequence types. The function of the filter remains unchanged from the previous device MAGNETOM Sola with syngo MR XA61A (K232535).

SVS_EDIT is newly added for MAGNETOM Skyra Fit, but without any changes (submitted with K203443)

Brain Assist received an improvement and is identical to that of snygo MR XA61A (K232535)

Open Recon is introduced for all systems. The function of Open Recon remains unchanged from the previous submissions (submitted with K221733).

Lock TR and FA in Bold received a minor UI update

Implant Suite is newly introduced for MAGNETOM Sola Fit and MAGNETOM Viato.Mobile, but without any changes (submitted with K232535)

myExam Autopilot Brain and myExam Autopilot Knee are newly introduced for the subject device MAGNETOM AVANTO Fit and are unchanged from previous submissions (submitted with K221733).

myExam Angio Advanced Assist (Test Bolus) received a bug fixing and minimal UI improvements.

The provided text is an FDA 510(k) clearance letter for various MAGNETOM MRI Systems. While it details new and modified software and hardware features, it does not include specific acceptance criteria or a study that "proves the device meets the acceptance criteria" in terms of performance metrics like sensitivity, specificity, or accuracy for a diagnostic task.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This is achieved by:

• Stating that the indications for use are the same.
• Listing numerous predicate and reference devices.
• Detailing hardware and software changes.
• Mentioning non-clinical tests like software verification and validation, sample clinical images, and image quality assessment to show that the new features maintain an "equivalent safety and performance profile" to the predicate devices.
• Referencing scientific publications for certain features to support their underlying principles and utility.
• Briefly describing the training and validation data for two AI features: Deep Resolve Boost and Deep Resolve Sharp, but without performance acceptance criteria or detailed results.

Therefore, much of the requested information cannot be extracted from this document because it is not a study report detailing clinical performance against predefined acceptance criteria for a specific diagnostic outcome.

However, I can extract the information related to the AI features as best as possible from the "AI Features/Applications training and validation" section (Page 16).

Acceptance Criteria and Study Details (Limited to AI Features)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Deep Resolve Boost:
  • Test Set Sample Size: Not explicitly stated as a separate "test set" size. The document mentions "training and validation data" for over 25,000 TSE slices, over 10,000 HASTE slices (for refinement), and over 1,000,000 EPI Diffusion slices. It's unclear what proportion of this was used specifically for final testing, or if the "validation" mentioned includes the final performance evaluation.
  • Data Provenance: Retrospective, described as "Input data was retrospectively created from the ground truth by data manipulation and augmentation." Country of origin is not specified.
• Deep Resolve Sharp:
  • Test Set Sample Size: Not explicitly stated as a separate "test set" size. The document mentions "training and validation" on more than 10,000 high resolution 2D images. Similar to Deep Resolve Boost, it's unclear what proportion was specifically for final testing.
  • Data Provenance: Retrospective, described as "Input data was retrospectively created from the ground truth by data manipulation." Country of origin is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The definition of "ground truth" for the AI features refers to the acquired datasets themselves rather than expert-labeled annotations. Visual comparisons are mentioned as part of the evaluation, but without details on expert involvement or qualifications.

4. Adjudication method for the test set

This information is not provided in the document. While "visual comparisons" and "visual rating" are mentioned, no specific adjudication method (e.g., 2+1, 3+1) is described.

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, a MRMC comparative effectiveness study demonstrating human reader improvement with AI assistance is not described in this document. The focus of the AI features (Deep Resolve Boost and Deep Resolve Sharp) is on image quality enhancement (denoising, sharpness) and reconstruction rather than assisting human readers in a diagnostic task that can be quantified by an effect size.

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

Yes, the evaluation of Deep Resolve Boost and Deep Resolve Sharp, based on metrics like PSNR, SSIM, and perceptual loss, and "visual comparisons" or "visual rating" appears to be an assessment of the algorithm's performance in enhancing image quality in a standalone capacity, without direct human-in-the-loop interaction for diagnosis.

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

• Deep Resolve Boost: "The acquired datasets (as described above) represent the ground truth for the training and validation." This implies the original, full-quality, unaltered MRI scan data. Further, "Input data was retrospectively created from the ground truth by data manipulation and augmentation. This process includes further under-sampling of the data by discarding k-space lines, lowering of the SNR level by addition Restricted of noise and mirroring of k-space data."
• Deep Resolve Sharp: "The acquired datasets represent the ground truth for the training and validation." Similar to Boost, this refers to original, high-resolution MRI scan data. For training, "k-space data has been cropped such that only the center part of the data was used as input. With this method corresponding low-resolution data as input and high-resolution data as output / ground truth were created for training and validation."

8. The sample size for the training set

• Deep Resolve Boost:
  • TSE: more than 25,000 slices
  • HASTE (for refinement): more than 10,000 HASTE slices
  • EPI Diffusion: more than 1,000,000 slices
• Deep Resolve Sharp: more than 10,000 high resolution 2D images.

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

• Deep Resolve Boost: The ground truth was established by the "acquired datasets" themselves (full-quality MRI scans). The training input data was then derived from this ground truth by simulating degraded images (e.g., under-sampling, adding noise).
• Deep Resolve Sharp: Similarly, the ground truth was the "acquired datasets" (high-resolution MRI scans). The training input data was derived by cropping k-space data to create corresponding low-resolution inputs.

Ask a specific question about this device

Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic 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 images 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.

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

MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/ Prisma/ with software syngo MR XA30A, include new and modified hardware and software compared to the predicate device, MAGNETOM Vida with software syngo MR XA20A. A high-level summary of the new and modified hardware and software is provided below:

Hardware

• New Computer

Software
New Features and Applications

• 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 is a pulse sequence that 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 and flow imaging are cleared features available on the predicate device. However, the combination of the two is new.
• Injector coupling is a software application that allows the connection of certain contrast agent injectors to the MR system for simplified, synchronized contrast iniection and examination start.
• The Prostate Dot Engine provides an assisted and guided workflow for prostate imaging. This automated workflow leads to higher reproducibility of slice angulation and coverage based on the segmentation algorithm described and cleared with syngo.via VB40; this may support exams not having to be repeated.

Modified Features and Applications

• An optimized high bandwidth inversion recovery pulse is combined with gradient echo readout to improve diagnostic image quality when imaging myocardial tissue.
• The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol.

Other Modifications and / or Minor Changes

• Elastography-AddIn synchronizes settings between the Elastography sequence and the active driver.
• HASTE MoCo is an image-based motion correction function in the averagedimension 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 provided document is a 510(k) summary for the Siemens MAGNETOM Aera, MAGNETOM Skyra, and MAGNETOM Prisma/Prismafit MR systems with syngo MR XA30A software. It details the device's substantial equivalence to a predicate device but does not describe specific acceptance criteria for a new feature's performance or a study demonstrating the device meets such criteria.

The document primarily focuses on demonstrating substantial equivalence by outlining:

• Device Description: New and modified hardware/software features (e.g., SVS EDIT, BEAT_FQ_nav, Injector coupling, Prostate Dot Engine, optimized high bandwidth inversion recovery pulse, AbsoluteShim mode, Elastography-AddIn, HASTE MoCo, Coil independent pulse sequences).
• Nonclinical Tests: These include "Sample clinical images," "Image quality assessments using sample clinical images," "Performance bench test," and "Software verification and validation." The results "demonstrate that the devices perform as intended and are therefore, substantially equivalent to the predicate device to which it has been compared."
• Clinical Tests/Publications: No clinical tests were conducted to support substantial equivalence for the subject devices. However, "sample clinical images were provided," and "clinical publications were referenced to provide information on the use of the following features and functions" (listing publications for SVS_EDIT and Prostate Dot Engine).

Therefore, I cannot extract the specific information requested because it is not present in the provided text. The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details on sample sizes, data provenance, number of experts for ground truth, or adjudication methods for any specific test set.
• Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on the type of ground truth used for specific features.
• Training set sample size or how ground truth was established for a training set.

The document's purpose is to show that the new/modified features are substantially equivalent to existing ones and perform as intended through verification and validation activities, rather than presenting a performance study against predefined acceptance criteria for novel functionalities.

Ask a specific question about this device

Your 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 images 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.

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

MAGNETOM Sola, MAGNETOM Altea and MAGNETOM Sola Fit with software syngo MR XA20A includes new and modified hardware and software compared to the predicate device, MAGNETOM Sola with software syngo MR XA11A. A high level summary of the hardware and software is provided below:

Hardware

• Computer
• Nose Marker for Inline Motion Correction
  Coils
• BM Body 18: The new BM Body 18 coil is a receive coil with 18 elements and is based on the Body 18 coil, (cleared with K101347). It is a general purpose coil.
  The BM Body 18 coil can be used with two different cables of different length; this capability was introduced with the BM Body 12 coil.

Software
Features and Applications

• SMS for TSE DIXON: Simultaneous excitation and acquisition of multiple slices with the Simultaneous multi-slice (SMS) technique for TSE Dixon imaging.
• GOLiver is a set of optimized pulse sequence 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.
• Angio TOF with Compressed Sensing (CS): The Compressed Sensing (CS) functionality is now available for TOF MRA within the BEAT pulse sequence type for the 1.5 T MR systems. Scan time can be reduced by an incoherent undersampling of k-space data. The usage of CS as well as the acceleration factor and further options can be freely selected by the user.
• RT Respiratory self-gating for FL3D VIBE: Non-contrast abdominal and thoracic examination in free breathing with reduced blur induced by respiratory motion.
• i SMS for RESOLVE and QDWI: Simultaneous excitation and acquisition of multiple slices with the Simultaneous multi-slice (SMS) technique for readout-segmented echo planar imaging (RESOLVE) and quiet diffusion weighted imaging (QDWI).
• SPACE with Compressed Sensing (CS): The Compressed Sensing (CS) functionality is now available for the SPACE pulse sequence type. Scan time can be reduced by the incoherent under-sampling of the k-space data. The usage of CS as well as the acceleration factor and other options can be freely selected by the user.
• SEMAC: SEMAC is a method for metal artifact correction in ortho imaging of patients with whole joint replacement. Using Compressed Sensing the acquisition can be accelerated.
• TSE MDME: A special variant of the TSE pulse sequence type which acquires several contrasts (with different TI and TE, i.e. Multi Delay Multi Echo) within a single sequence.
• TFL (3D MPRAGE), TSE and GRE with Inline Motion Correction: 3D -MPRAGE, TSE and GRE with Inline Motion Correction: Tracking of motion of the head during head scans with a nose marker and a camera system. The MR system uses the tracking information to compensate for the detected motion.
• EP SEG PHS: pulse sequence type EP SEG PHS, based on BEAT EPI and modified with a silent period that can be used by external devices/applications for synchronization with the MR imaging
• GRE PHS: pulse sequence type GRE PHS, is a GRE pulse sequence type, modified to provide a silent period that can be used by external devices/applications for synchronization with the MR imaging.
• GRE Proj: The GRE projection pulse sequence type "" allows the acquisition of 1-D projection data for different orientations.
• GOKnee2D: GOKnee2D is a set of multi-band pulse sequence types with Simultaneous Multislice TSE for fast and efficient imaging of the knee. It is designed to provide consistent exam slots and to reduce the workload for the user in Knee MRI.
• BEAT_interactive: The BEAT_Interactive pulse sequence type is a modification of the BEAT IRTTT pulse sequence type in order to interactively increase the slice thickness and switch on and off a magnetization pulse that the user can select prior to the measurement start.
• EP2D SE MRE: As an alternative of greMRE, EP2D SE MRE pulse sequence type is based on single-shot EP2D_SE_MRE sequence. It offers acquisition of multiple slices in a single, short breath-hold, and it is more robust against signal dephasing effects while providing comparable relative stiffness values.
• ZOOMit DWI: syngo ZOOMit based on EPI diffusion allows diffusion weighted imaging (DWI) while avoiding signal and artifacts from surrounding tissue. The feature is now available for 1-ch-systems and enables improved robustness to infolding artifacts from tissue from outside the excited reqion.
• SPACE Flair Improvements: SPACE pulse sequence type offers a magnetization preparation mode for brain imaging with FLAIR contrast (FLuid Attenuated Inversion Recovery); improving the image quality of FLAIR images.
• External Phase Correction Scan for EPI Diffusion: Separate N/2 Nyquist ghost correction acquisition method for diffusion imaging in the presence of fat.
• MR Breast Biopsy Workflow improvements: The changes made to MR Breast Biopsy application target two areas: the improved readability of planning results and the ability to handle the planning of multiple biopsy targets.
• GOBrain / GOBrain+: GOBrain (brain examination in short acquisition time) GOBrain+ (adaptation of GOBrain pulse sequences)

Software / Platform

• Dot Cockpit: MR Protocol Manager as part of a scanner fleet with connection via a share.
• Access-i: The interface Access-i allows 3rd party devices to establish a bidirectional communication with the MR scanner via a secure local network connection, supporting data transfer to and triggering of data acquisition from the 3rd party device. It enables the 3rd party client to control and edit a measurement program on the MR.
• Table positioning mode: A new table positioning mode "FIX" is introduced which complements the existing table positioning modes ISO and LOC to support workflows in which the user needs to be in control of a defined Zposition at which measurements get executed.

Other Modifications and / or Minor Changes

• MAGNETOM Sola Fit: The MAGNETOM Sola Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Aera.
• BM Body 12: For MR examinations of head and neck in situations where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution as what can be achieved with 4-channel Flex rf coils
• Body 18: For MR examinations of head and neck in situations, where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution than what can be achieved with 4-channel Flex rf coils
• UltraFlex Large 18, UltraFlex Small 18: For MR examinations of head and neck in situations, where a rigid rf head coil cannot be used, e.g. with patients positioned in thermoplastic masks used for radiotherapy planning, aiming at higher signal-to-noise and spatial resolution than what can be achieved with 4channel Flex rf coils
• Broad band / narrow band online supervision: The broadband/narrowband supervision checks the correctness of the measurement values used for the SAR calculation. With syngo MR XA20A, the supervision cycle is reduced significantly.
• LiverLab Dot Engine debundling: LiverLab is now offered separately as standalone workflow and is also still available as part of the Abdomen Dot Engine.
• The 1.5T system MAGNETOM Altea is made available to the marked with software syngo MR XA20A.

This document is a 510(k) summary for the Siemens MAGNETOM Sola, Altea, and Sola Fit MRI systems with software syngo MR XA20A. It outlines their substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Important Note: This document primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device for a Magnetic Resonance Diagnostic Device (MRDD). The testing described is largely for demonstrating the safety and performance of new and modified hardware and software features in comparison to the predicate. It is not a clinical study proving diagnostic accuracy of an AI algorithm, a typical scenario for the detailed acceptance criteria you requested. Therefore, many of your specific questions regarding AI algorithm performance (e.g., MRMC studies, ground truth for training data, effect size of human improvement with AI) are not applicable or not explicitly detailed in this type of 510(k) submission for an MRI system.

The "acceptance criteria" here relate more to the performance and safety of the MRI system itself, rather than diagnostic accuracy of an AI algorithm based on a specific clinical endpoint.

Acceptance Criteria and Reported Device Performance

The document presents the testing conducted to support the substantial equivalence of the new and modified hardware and software components of the MAGNETOM systems. The "acceptance criteria" are implied by the successful completion of these nonclinical tests and their demonstration that the device performs as intended and is equivalent to the predicate.

Table of Acceptance Criteria and Reported Device Performance (Implied from Nonclinical Tests):

Study Details (Based on Provided Text)

Given that this is a 510(k) for an MRI system with new/modified features, and not an AI diagnostic algorithm, the "study" is a collection of nonclinical tests.

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

   • The document states "Sample clinical images were provided" for image quality assessment. It does not specify the number of images or patients (sample size) used for these assessments.
   • Data provenance (country of origin, retrospective/prospective) is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For the "Image quality assessments by sample clinical images," it's stated, "when interpreted by a trained physician, yield information that may assist in diagnosis."
   • However, the number and qualifications of experts involved in the assessment of these sample clinical images for the purpose of the 510(k) submission are not specified. This is likely an internal verification step, not a formal clinical trial with external readers.

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

   • Not specified. Given the nature of the nonclinical testing for device features, a formal adjudication process for "ground truth" (as expected for diagnostic performance studies) is not described. The assessments were likely internal comparisons to predicate performance.

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:

   • No MRMC study described. This 510(k) is for an MRI system, not an AI diagnostic algorithm. The improvements mentioned ("fast and efficient imaging," "reduce the workload") are theoretical benefits of the features themselves, not a quantified improvement in human reader performance with AI assistance. The document explicitly states "No additional clinical tests were conducted to support substantial equivalence for the subject devices."

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

   • Not applicable. This document describes an MRI system, not a standalone AI algorithm. The software features are integrated into the system for image acquisition and processing.

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

   • The term "ground truth" as it pertains to clinical diagnostic accuracy is not explicitly used or established in this context. The "truth" for these nonclinical tests is based on the device meeting its engineering specifications, performing equivalently to the predicate, and producing images of acceptable quality when interpreted by a trained physician. The images themselves serve as the output, assessed against expected image quality parameters.

7. The sample size for the training set:

   • Not applicable / Not specified. This document describes a medical device (MRI system) with software and hardware features, not a machine learning model that requires a "training set" in the common sense. Any internal development data used to refine pulse sequences or image reconstruction is not considered a "training set" in the context of AI regulatory submissions.

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

   • Not applicable / Not specified. See point 7.

Ask a specific question about this device

The Motion Correction System is an accessory to a Magnetic Resonance Imaging (MRI) scanner. The system is a sensorbased technology for tracking of patient movement during an MRI session. It provides the current position of the patient in real-time to the MRI scanner for further data processing.

User: Professional Use

Environment: Hospital, doctor's office, or any facility that uses an MRI device

KinetiCor defines the Motion Correction System as an accessory to a medical device. It is intended to supplement and/or augment the performance of the MAGNETOM Skyra 3T MRI scanner.

During an MRI scan, if the patient's head does not remain still during the scan, the resulting images may not be sharp. This could prevent a physician from analyzing the images, therefore requiring additional scanning.

Software has been developed to somewhat reduce these effects.

KinetiCor has developed a Motion Correction technology using a track the true position of the patient's head. These coordinates are provided to the MRI scanner, which adjusts the MR images.

The Motion Correction System delivers head pose tracking and correction in 6 degrees of freedom for MR applications.

• . Optimized for high field MR environments, the technology has been FDA Cleared for use in the MAGNETOM Vida, 510(k) K183254, cleared January 18, 2019. Customized optics, electronics and enclosures minimize Electromagnetic Interference (EMI) and Radiofrequency (RF) interference and isolate the camera system for stable tracking accuracy.
• . Proprietary optical machine vision tracking technology provides tracking data to the MRI scanner with a static accuracy of approximately 0.1 mm and 0.1 deg. This means that the MR pulse sequences are updated in real-time.
• The impact of the Motion Correction technology can be illustrated by taking a closer look at the corrected and uncorrected images in the figure below.

The Motion Correction System Hardware consists of the following:

• Camera Enclosure (incorporating four Cameras) located inside the distal end of the MRI scanner; ●
• Wiring Conduit - provides a protected location for wiring to exit the distal end of the MRI scanner;
• Processing Unit - electronics with software, located outside the MRI room;
• External Wiring - used to connect processing unit to Camera Enclosure;
• . Tracking Markers - single use markers located on patient nose bridge (Referred to as "Nose Marker for Inline Motion Correction" in predicate device);
• External Monitor - if requested, located inside MRI Control Room;
• Network System located outside the MRI room.

Here's an analysis of the acceptance criteria and study information for the KinetiCor Motion Correction System (K193324) based on the provided text, structured as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or a reported device performance table in the typical format of a clinical study outcome. Instead, it describes the technology's performance capabilities and its substantial equivalence to a predicate device.

However, based on the description, we can infer some performance claims:

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

• Sample Size for Test Set: The document does not specify a numerical sample size for a test set in terms of patient numbers or a dataset size for evaluating device performance. The non-clinical tests mention "Software Verification and Validation testing" and "Design Verification and Validation testing" but don't provide details on the data used.
• Data Provenance: The document does not specify the country of origin of data or whether it was retrospective or prospective for any performance evaluation directly linked to the KinetiCor Motion Correction System. The comparative images (corrected vs. uncorrected MRI scans) are presented as illustrative examples, not as part of a formal study with specified provenance.

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

The document does not provide information on the number of experts, their qualifications, or how ground truth was established by experts for a specific test set. The visual comparison of "corrected" and "uncorrected" images implies a qualitative assessment of image quality, but this isn't attributed to a formal expert review process with specified criteria or adjudicators.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The device is a motion correction system directly influencing image quality, rather than an AI diagnostic aid that assists human readers in interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone performance assessment was effectively done for the core function of the motion correction system, though not presented as a formal study in the typical sense of a diagnostic algorithm. The description states:

• "Proprietary optical machine vision tracking technology provides tracking data to the MRI scanner with a static accuracy of approximately 0.1 mm and 0.1 deg."
• "The MR pulse sequences are updated in real-time."
• The comparison of "Motion correction using KinetiCor technology" versus "MR images obtained when the motion was not corrected" (Figure on page 5) directly illustrates the system's performance in isolation from human interpretation. The effectiveness is demonstrated by the improved image quality produced by the system itself.

7. Type of Ground Truth Used

The ground truth for the motion correction capabilities appears to be based on:

• Quantitative measurements: The stated static accuracy of 0.1 mm and 0.1 deg implies a technical measurement against a known, precise reference or standard for validating the tracking technology.
• Visual comparison/Qualitative assessment: The "corrected" versus "uncorrected" image examples serve as a qualitative ground truth demonstrating the visual improvement in image quality due to the system's function. The "similar motion performed during both scans" indicates a control for comparing the effect of the system.
• The device is framed as an accessory to improve image quality, and its "effectiveness" is linked to this improvement, rather than a diagnostic outcome for which pathology or outcomes data would be the ground truth.

8. Sample Size for the Training Set

The document does not specify a sample size for any training set. It mentions "Proprietary optical machine vision tracking technology," which implies algorithms that might have been trained, but no details are provided.

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

The document does not provide information on how the ground truth for any training set was established.

Ask a specific question about this device

Your MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images 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 images 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 MR 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.

The subject device, MAGNETOM Avanto and MAGNETOM Verio D with software syngo MR E11D, is a modification of the previously cleared predicate device, MAGNETOM Avanto and MAGNETOM Verio with software syngo MR D13A (K121434). Software version syngo E11D for MAGNETOM Avanto and MAGNETOM Verio includes software applications migrated from the previously cleared MAGNETOM Aera and Skyra systems with syngo MR E11C (K153343). Only minor adaptations were needed to support the system specific hardware and optimize the sequence/protocols. The description lists new and modified sequences/algorithms, new and modified applications, and new hardware components.

Here's the breakdown of the acceptance criteria and study information based on the provided text, specifically for the K181613 submission for MAGNETOM Avanto and MAGNETOM Verio with software syngo MR E11D:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and quantitative performance results for a new, novel AI algorithm. The performance is assessed primarily through verification and validation testing against established standards and equivalency to previously cleared predicate devices.

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

• Test Set Sample Size: The document does not explicitly state a specific sample size for a "test set" in the context of a prospective, human-read study with a defined dataset for performance evaluation. Instead, it mentions "non-clinical data" and "sample clinical images."
• Data Provenance: The document generally refers to "non-clinical data" and "sample clinical images." There is no information regarding the country of origin or whether the data was retrospective or prospective. The "sample clinical images" were provided "in accordance with the FDA guidance document, 'Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices,'" but the details of these images (e.g., number, origin) are not elaborated.

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

There is no information provided in the document regarding the number of experts or their qualifications for establishing ground truth for any specific test set. The submission focuses on the performance of the MR system itself, not necessarily an AI-driven image analysis tool requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

There is no information provided regarding any adjudication method, as the study described is not an AI performance study that typically involves expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

No, an MRMC comparative effectiveness study involving AI assistance for human readers was not done or reported in this 510(k) summary. The device in question is a magnetic resonance diagnostic device (MR system) and its updated software, not an AI-driven diagnostic algorithm used to assist human readers.

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

The document describes performance testing of the entire MR system and its software, not a standalone algorithm. The "new sequences or algorithms" and "applications" mentioned are integral parts of the MR system's functionality, producing images and spectra for interpretation by a trained physician. Therefore, a standalone algorithm-only performance study (as would be typical for an AI diagnostic device) was not performed or reported in this context.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically defined for AI performance studies (e.g., pathology, outcomes data, expert consensus) is not explicitly addressed nor applied in this submission. The device's performance is evaluated against its intended function (producing images, spectra, and physical parameters) and its equivalence to a predicate device, which implies that the output (the images themselves) is the primary "truth" and is interpreted by a trained physician.

8. The Sample Size for the Training Set

Since this submission is for an updated MR system software and not a de novo AI algorithm, there is no mention or requirement for a "training set" in the context of machine learning. The software updates described include new and modified sequences or algorithms and applications, which are developed and validated through traditional software engineering and control methods, not machine learning model training.

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

As there is no training set discussed in this document for an AI algorithm, the question of how ground truth was established for it is not applicable.

Ask a specific question about this device

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 Vida with software syngo MR XA11A includes new and modified hardware and software compared to the predicate device, MAGNETOM Vida with syngo MR XA10A. A high level summary of the new and modified features is provided below:

Hardware
New Hardware

• New coils:
• BM Body 12 |
• BM Spine 24 |
• | Head/Neck 16
• -Head 32 MR Coil 3T
• Other components:
• camera —
• computer
• Multi-Channel Interface —

Modified Hardware

• Main components such as 32 independent RF channels -
• -Other components such as Tx-Box / RF filter plate / transmit system

Software
New Features and Applications

• GOKnee3D (examination comprising the AutoAlign knee localizer and two SPACE with CAIPIRINHA sequences to support fast high-resolution 3D exams of the knee)
• SPACE with CAIPIRINHA (3D SPACE pulse sequence type with the iPAT mode CAIPIRINHA)
• GOBrain (brain examination in short acquisition time)
• GOBrain+ (adaptation of GOBrain pulse sequences)
• | MR Breast Biopsy (supports planning and execution of MR guided breast biopsies and wire localizations)
• | MRSim / Synthetic CT (provides MR pulse sequences for the creation of Synthetic CT images based on the MR image input)
• Cardiac Dot Flow Add-In (extension of Cardiac Dot Engine to support blood flow measurements)
• PCASL mode (extension of ASL pulse sequence types by a new blood labeling mode)
• SMS in TSE (Simultaneous Multi Slice (SMS) support for TSE)

Modified Features and Applications

• | SliceAdjust (the framework support was extended to include additional pulse sequence types)

• RetroGating (Compressed Sensing Cardiac Cine acquisitions which split the data acquisition over multiple heartbeats can now be configured to perform complete sampling of the cardiac cycle without prior definition of an acquisition window. Combination with arrhythmia rejection is possible.)

• iPAT / TSE Reference Scan (Changes in the TSE, FAST TSE and TSE DIXON pulse sequence types includes the possibility to use a reference scan "TSE/Separate" for GRAPPA acquisition and reconstruction)

• Care Bolus in Angio Dot Engine (workflow support for bolus administration (bolus detection))

• MRCP in SPACE (improvement of the image quality for MR Cholangiopancreatography (MRCP) acquisitions based on the SPACE pulse sequence type)

• MR Elastography:

• Replacement of existing masking by masking performed on the prescan images used within the prescan/normalize (PSN) functionality.

• Optimization of pulse sequence type timing. |

• Changes in MEG time period (no longer fixed to the wavelength of the | MEG and also implementation of a reduced MEG period)

• Respiratory Sensor Support (additional support for respiratory triggered measurements is provided in several SE-, GRE- and EPI-based pulse sequence types)

Modified (general) Software / Platform

• ー Single and dual monitor workflow (In the single monitor setup the features of the LHS monitor and RHS monitor are provided on separate tab-cards)
• Touch positioning (Select&GO 2.0) (extension to additional body area positions when dedicated coils are plugged in)
• Dot Cockpit (additional features for handling of scan pulse sequences and offline Dot Cockpit)
• MR View&GO (Addition of Mosaic View (view mode to scroll through dimensions | instead of space) and 4D Movie Toolbar (movie toolbar to navigate the 4th dimension))

Other Modifications and / or Minor Changes

• teamplay Protocols Interface (interface to support external pulse sequences | management systems)

• Unilateral Hip (added in Large Joint Dot Engine) (user workflow optimized, since information/settings are taken from the patient registration)

• GRE RefScan (external GRE RefScan has been extended to multiple pulse sequence types)

• Asymmetric saturation pulses (support for regional saturation with an asymmetric shape has been added for BOLD imaging)

• CP Mode modification ("RF Transmit Mode" is provided as part of the patient registration based on IEC 60601-2-33)

• SPAIR FatSat (new "SPAIR Breast" mode in several pulse sequence types and extension of "Abdomen&Pelvis" and "Thorax" modes)

• Compressed Sensing GRASP-VIBE (improvement of SPAIR fat saturation performance)

• MAGNETOM RT Pro Edition marketing bundle (extension of the bundle)

• Siemens "BioMatrix" (extension with additional components)

The provided text is a 510(k) Summary for the Siemens MAGNETOM Vida MRI system (K181433). It describes the device, its intended use, and compares it to a predicate device (MAGNETOM Vida with syngo MR XA10A). However, this document primarily focuses on establishing substantial equivalence based on non-clinical testing and adherence to standards, rather than clinical performance studies with acceptance criteria in the typical sense for AI/CADe devices.

Therefore, many of the requested details regarding acceptance criteria, clinical study design (sample size, expert qualifications, adjudication, MRMC studies, standalone performance), and ground truth establishment (especially for AI/ML models) are not present in this document. This is because this submission is for an MRI system, not an AI/CADe device. It focuses on hardware and software modifications of a diagnostic imaging machine, not on an algorithm that interprets images.

Based on the provided text, here's what can be inferred:

1. A table of acceptance criteria and the reported device performance:

The document discusses "performance testing" but does not provide specific quantitative acceptance criteria or detailed reported performance in a table format as might be expected for an AI/CADe device. Instead, the "acceptance" is qualitative:

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

• Test Set Sample Size: Not explicitly stated. The document mentions "sample clinical images" were taken for the new coils and software features, but no specific number of patients or images is given.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
• Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not specified.
• Qualifications of Experts: The device's output is "interpreted by a trained physician," implying that physicians are involved in assessing the images, but their specific role in establishing "ground truth" for the non-clinical tests is not detailed. For this type of MRI system submission, ground truth isn't established in the same way as for an AI interpretation algorithm. The "truth" is the physical output of the MRI system.

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

• Not applicable/Not specified. This level of detail on ground truth adjudication is typically for AI/CADe clinical studies, not MRI system performance tests focused on image quality and safety.

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 MRMC study was done. The document explicitly states: "No clinical tests were conducted to support substantial equivalence for the subject device". This is not an AI-assisted reading device, but a diagnostic imaging system.

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

• Not applicable. This is an MRI device, not an AI algorithm. "Performance tests" were done on the device itself and its components (e.g., image quality assessments).

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

• For an MRI system, the "ground truth" for non-clinical testing refers to the physical and technical performance of the device (e.g., image clarity, signal-to-noise ratio, spatial resolution, adherence to safety limits). It is not about diagnostic accuracy against a clinical ground truth like pathology. The comparison is made against prior versions/predicate devices and established industry standards for image quality and safety.

8. The sample size for the training set:

• Not applicable. This document does not describe an AI/ML algorithm that requires a training set.

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

• Not applicable. As above, no AI/ML training set is discussed.

In summary: The provided document is a 510(k) summary for a Magnetic Resonance Diagnostic Device (MRDD), the MAGNETOM Vida MRI system. Its purpose is to demonstrate substantial equivalence to a legally marketed predicate device based on non-clinical performance testing (e.g., image quality assessments, software verification/validation) and conformity to recognized standards (e.g., IEC, ISO, NEMA). It explicitely states that no clinical tests were conducted for this submission. Therefore, the detailed requirements for AI/CADe device performance studies (like MRMC, training/test set ground truth, expert adjudication, etc.) are not addressed in this document because they are not relevant to this specific type of medical device submission.

Ask a specific question about this device

The MAGNETOM systems are indicated for use as a magnetic resonance diagnostic 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 mages and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

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

MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/Prisma" with syngo MR E11C software were cleared with K153343 and MAGNETOM Avanto" and MAGNETOM Skyrafff systems with syngo MR E11C software were cleared with K162102.

To address the new feature GOKnee3D and the modifications summarized in Section 3 and furthermore described in this Premarket Notification Siemens intends to make the software application package syngo MR E11C - AP04 available to the systems mentioned above.

The additional options for the synqo MR E11C software is being made available for the following MAGNETOM MR Systems:

• . MAGNETOM Aera,
• MAGNETOM Skyra / Skyraf" ●
• MAGNETOM Prisma / Prisma™ ●
• MAGNETOM Avantofit .

Those options include a new feature with a modified sequence and modified features for the above mentioned MR systems. A high level summary of sequences, features and improvements made available for the above systems is included below.

The provided text does not contain information about specific acceptance criteria, a study proving a device meets these criteria, or detailed performance metrics. The document is a 510(k) premarket notification summary for Siemens MAGNETOM MRI systems, explaining their substantial equivalence to previously cleared devices.

It discusses:

• Device Name: MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit with syngo MR E11C - AP04 software.
• Intended Use: Magnetic resonance diagnostic device (MRDD) for imaging internal structures and functions of the head, body, or extremities, assisting in diagnosis.
• New Feature: GOKnee3D (fast, push-button knee examination with AutoAlign knee localizer and two CAIPIRINHA SPACE sequences).
• Modified Features: SPACE with CAIPIRINHA acquisition technique, Dual Monitor support, Compressed Sensing Cardiac Cine (BEAT_CS Sequence).
• Technological Characteristics: Similar to predicate devices, conforming to IEC 62304:2006 and other standards.
• Nonclinical Tests: Performance testing for modified sequence (CAIPIRINHA SPACE), image quality assessments of new sequences/algorithms, software verification and validation.
• Clinical Tests: "No clinical tests were conducted to support the subject devices and the substantial equivalence argument; however, clinical images and LV evaluation were provided to support the argumentation and documentation which demonstrate the clinical utility and technical capabilities of the method."
• Safety and Effectiveness: Risk management via ISO 14971:2007, adherence to IEC 60601-1 series, and compliance with FDA recognized standards.
• Substantial Equivalence: Concluded based on identical intended use and similar technological characteristics to predicate devices. The hardware is unchanged.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as this information is not present in the provided text. The document explicitly states that no clinical tests were conducted, and the assessment relies on nonclinical tests and substantial equivalence to predicate devices.

Ask a specific question about this device

Your MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body, or extremittes. 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 images 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 MR 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.

The subject device, MAGNETOM Amira with syngo MR E11S, is a modification of the previously cleared predicate device, MAGNETOM Amira with syngo MR E11N (K152283). Software version syngo E11S for MAGNETOM Amira includes software applications migrated from the previously cleared MAGNETOM Aera systems with syngo MR E11C and E11C - AP02 (K153343 and K163312). Only minor adaptations were needed to support the system specific hardware and optimize the sequence/protocols. The following are the software applications migrated from previously cleared software to the subject device:

• . fast TSE
  • o Improvements in BLADE Imaging
• SMS EPI .
  • o Simultaneous Multi Slice Imaging
• Quiet DWI .
  • o Noise reduced sequence for diffusion weighted imaging
• GOBrain ●
  • o Supports brain examination in short acquisition time
• GOBrain+ ●
  • o GOBrain adaptation to support protocols developed for contrast enhanced imaging of the brain

Listed below are the hardware updates to the MAGNETOM Amira with syngo MR E11S:

• Updated MRAWP/MRWP (Syngo Acquisition Workplace/ Syngo Workplace) . based on the new host platform-HP Z440.
• Endorectal interface and adapter to connect the Endorectal Coil (to be ordered . separately) to the MAGNETOM Amira systems.

The MAGNETOM Amira with software version syngo MR E11S will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Amira systems.

This document describes the MAGNETOM Amira with software syngo MR E11S device. Based on the provided text, the device is a modification of a previously cleared Magnetic Resonance Diagnostic Device (MRDD) and no new acceptance criteria or new studies were performed to prove the device meets acceptance criteria. Instead, the manufacturer argues for substantial equivalence to existing predicate devices.

Here's an analysis based on the information provided and what can be inferred about the "acceptance criteria" through the lens of substantial equivalence for this type of device:

1. A table of acceptance criteria and the reported device performance

The provided document does not explicitly state specific acceptance criteria (e.g., in terms of sensitivity/specificity/accuracy) or quantitative performance metrics for the MAGNETOM Amira with software syngo MR E11S.

The "acceptance criteria" for this device, being a modification of an existing MRDD, are implicitly tied to demonstrating that it performs as intended and is as safe and effective as its predicate devices. This is shown through verification and validation activities (non-clinical performance testing) and by confirming that the technological characteristics and indications for use are substantially equivalent to cleared devices.

The reported device performance is that it "performs as intended" and demonstrates "equivalent safety and performance profile" as the predicate device.

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

• Sample Size for Test Set: The document mentions that "sample clinical images were taken for the endorectal coil." It does not specify the number of images or cases.
• Data Provenance: The document does not specify the country of origin of these "sample clinical images" or whether they were retrospectively or prospectively collected.

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)

This information is not provided in the document. Given that no clinical studies were performed to establish new performance metrics, it's unlikely that a formal ground truth establishment process involving multiple experts for a test set was undertaken for this substantial equivalence submission. The interpretation of images for diagnosis as mentioned in the Indications for Use is "by a trained physician," but this pertains to the general use of the device, not specific to establishing ground truth for a new performance study.

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

This information is not provided in the document.

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 MRMC comparative effectiveness study was done, as stated: "No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device." This device is a Magnetic Resonance Diagnostic Device, and the document doesn't indicate it incorporates AI for interpretation or assistance, thus the question of human reader improvement with AI is not applicable here.

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

This device is an MR system, a hardware and software diagnostic device for image acquisition and display. It is not an algorithm-only standalone diagnostic tool, and therefore, standalone algorithmic performance in the context of AI is not relevant or evaluated here. The performance is of the entire MR system.

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

Given that "No clinical tests were conducted," and the primary evaluation was for substantial equivalence through non-clinical performance testing and software verification/validation, a formal "ground truth" as typically established for new diagnostic accuracy claims (e.g., pathology-confirmed cases) was not used for this submission. The "sample clinical images" would likely have been used to subjectively confirm expected image quality and functionality, rather than for a quantitative ground truth comparison.

8. The sample size for the training set

This device is an MR diagnostic system, not an AI model that requires a distinct training set. The software updates are "migrated from previously cleared software," implying reuse and adaptation of existing, validated code and functionalities. Therefore, the concept of a "training set" in the context of machine learning does not apply here.

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

As the concept of a training set for an AI model is not applicable to this device as described, the establishment of ground truth for a training set is not relevant.

Ask a specific question about this device

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

The device is intended for patients > 30 kg/66 lbs.

MAGNETOM Terra is a 60 cm bore Magnetic Resonance Imaging system with an actively shielded 7T superconducting magnet. With the interplay of the magnetic field, gradients, radio frequency (RF) transmitter and receiver coil and software this magnetic resonance scanner produces transverse, sagittal, coronal and oblique cross sectional images that represent the spatial distribution of protons with spin. The MAGNETOM Terra uses two local coils 1Tx32Rx Head Coil 7T Clinic and 1Tx28Rx Knee Coil 7T Clinic for head and knee imaging.

The provided text describes the Siemens MAGNETOM Terra, a 7T Magnetic Resonance Imaging (MRI) system. However, it focuses on demonstrating substantial equivalence to a predicate device (MAGNETOM Trio A Tim System with syngo MR B19A) rather than establishing novel safety and effectiveness through specific acceptance criteria and a dedicated study demonstrating the device meets those criteria for a new clinical indication or outcome.

The text outlines various non-clinical tests and a clinical study primarily to ensure the device's fundamental safety and performance within the established framework for MRI devices, especially given the increased magnetic field strength (7T). It does not present a study designed to prove the device meets specific acceptance criteria related to a new clinical performance claim or diagnostic accuracy.

Therefore, many of the requested sections (Table of acceptance criteria, device performance, sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used for test set, training set details) are not applicable or extractable from this document as the submission does not detail a study aimed at proving a specific clinical performance criterion for this device as a new clinical claim.

Below is a summary of the information that can be extracted or inferred based on the document's content:

1. A table of acceptance criteria and the reported device performance

No explicit "acceptance criteria" table for a specific clinical performance claim is provided. The submission focuses on demonstrating compliance with recognized standards and substantial equivalence to a predicate device. Performance is generally assessed via image quality and safety parameters.

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

• Sample size for nerve stimulation threshold study: 35 individuals.
• Data provenance: Not explicitly stated whether retrospective or prospective, or country of origin. It is a "clinical study" performed to set PNS thresholds.
• Sample images for image quality assessment: Not specified beyond "sample clinical images were acquired for all available clinical pulse sequences and local coils."

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)

• For nerve stimulation threshold study: Not applicable, as this study determines physiological thresholds, not ground truth for diagnostic imaging interpretation.
• For image quality assessment: "reports from two U.S. board-certified radiologists have been provided after the radiologists reviewed image pairs comparing the subject and the predicate device." Their specific experience level is not mentioned beyond "board-certified." This implies a qualitative assessment, not a formal ground truth establishment for a diagnostic study.

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

• For image quality review: Not explicitly detailed beyond "two U.S. board-certified radiologists... reviewed image pairs comparing the subject and the predicate device [and their] comments on any observed artifacts and concerns have also been included." This suggests a qualitative comparison rather than a formal adjudication process for diagnostic accuracy.

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 MRMC comparative effectiveness study is mentioned, nor is there any AI component described in the device. This device is an MRI scanner, not an AI-powered diagnostic tool.

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

• Not applicable, as this is an MRI scanner, not an algorithm being evaluated for standalone diagnostic performance.

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

• For nerve stimulation threshold study: The "ground truth" is the empirically observed nerve stimulation thresholds in the 35 individuals, which defines the physiological limits for setting the PNS threshold level.
• For image quality assessment: The "ground truth" or reference is implied to be the qualitative assessment and comparison by board-certified radiologists against the predicate device, focusing on image characteristics and artifacts. No objective ground truth (e.g., pathology, clinical outcomes) is stated as being used to assess diagnostic accuracy.

8. The sample size for the training set

• Not applicable/provided. This submission does not describe a machine learning algorithm that requires a training set. The software development is based on an existing software line and adapted for 7T parameters. The SAR control software enhancements are based on simulations with human models.

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

• Not applicable, as no training set for a machine learning algorithm is described. The SAR control software relies on computational modeling and simulation data using established human models (Virtual Population, MIDA Model) to estimate local SAR.

Ask a specific question about this device

Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body, or extremittes. 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 mages 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 Vida with software syngo MR XA10A is similar to the previous cleared predicate device MAGNETOM Skyra with syngo MR E11C (K153343) but includes new and modified hardware and software compared to MAGNETOM Skyra.

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

Preamble: It's important to note that this document is a 510(k) summary for a premarket notification for a Class II medical device (Magnetic Resonance Diagnostic Device). The primary goal of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove absolute efficacy in a clinical setting in the same way a PMA (Premarket Approval) might require. Therefore, the "acceptance criteria" and "device performance" are primarily focused on meeting established standards and showing that changes do not negatively impact safety or effectiveness compared to the predicate.

Acceptance Criteria and Reported Device Performance

The general acceptance criteria are that the device performs as intended and is "substantially equivalent" to the predicate device, especially regarding safety and effectiveness. The specific performance reported largely revolves around conformance to recognized standards and successful completion of verification and validation.

Table of Acceptance Criteria and Reported Device Performance:

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Clinical Study (PNS Threshold): 33 individuals. The document does not specify the country of origin or whether it was retrospective or prospective, but clinical studies for such thresholds are typically prospective.
   • Nonclinical Tests (Image Quality, Software V&V, Performance Tests): The document does not specify a numerical sample size but mentions "sample clinical images were taken" for new coils and software features. It does not provide provenance (country, retrospective/prospective) for these samples specifically, but they would likely be internal studies.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the image quality assessments, software V&V, or performance tests. However, it indicates that the interpretation of images and spectra is done "by a trained physician." For image quality assessments, it's implied that Siemens' internal experts or qualified personnel performed these.

3. Adjudication Method for the Test Set:

   • The document does not specify an adjudication method like 2+1 or 3+1 for any of the tests described.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned for the entire device. The submission focuses on demonstrating substantial equivalence through compliance with standards, verification, and validation, rather than a direct comparison of reader performance with and without the new AI features (if any specific AI features are implied, they are integrated within the "new software" and not evaluated separately as AI-assisted reading).
   • There is no mention of an effect size for human readers with vs. without AI assistance.

5. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • No standalone performance study of an algorithm is explicitly described. The device is an MRI system, which always involves a human operator and physician interpretation. The "new software" features are part of the overall system performance, not presented as a discrete AI algorithm for standalone evaluation.

6. Type of Ground Truth Used:

   • PNS Threshold Study: The ground truth would be the observed physiological response (nerve stimulation) in the 33 individuals, used to set the safety threshold.
   • Image Quality Assessments: The ground truth would likely be internal Siemens expert assessment of expected image characteristics, clarity, and diagnostic interpretability against established quality metrics or comparisons to images from the predicate device.
   • Software V&V/Performance Tests: Ground truth would be derived from specifications, expected functional outputs, and adherence to regulatory standards.
   • General Diagnosis: The "Indications for Use" state that images and spectra, "when interpreted by a trained physician yield information that may assist in diagnosis." This implies physician interpretation is the ultimate ground truth for diagnostic purposes in clinical use, but not for the technical performance studies described in the 510(k).

7. Sample Size for the Training Set:

   • The document does not provide information on a specific training set size. This type of 510(k) submission generally does not detail the internal development and training data for software components, especially when the changes are primarily updates to an existing system, rather than a de novo AI algorithm approval.

8. How the Ground Truth for the Training Set Was Established:

   • Since no specific training set or study for algorithm training is described, the method for establishing its ground truth is not provided.

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