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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 devices, MAGNETOM Aera (including MAGNETOM Aera Mobile), MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma™, MAGNETOM Vida, MAGNETOM Lumina with software syngo MR XA60A, consist of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Vida with syngo MR XA50A (K213693).

This FDA 510(k) summary describes several updates to existing Siemens Medical Solutions MRI systems (MAGNETOM Vida, Lumina, Aera, Skyra, Prisma, and Prisma fit), primarily focusing on software updates (syngo MR XA60A) and some modified/new hardware components. The document highlights the evaluation of new AI features, specifically "Deep Resolve Boost" and "Deep Resolve Sharp."

Here's an analysis of the acceptance criteria and the study details for the AI features:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a general overview of the evaluation metrics used but does not explicitly state acceptance criteria in a quantitative format (e.g., "Deep Resolve Boost must achieve a PSNR of X" or "Deep Resolve Sharp must achieve Y SSIM"). Instead, it describes the types of metrics used and qualitative assessments.

• Impact characterized by PSNR and SSIM. | The impact of the network has been characterized by several quality metrics such as peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM). Most importantly, the performance was evaluated by visual comparisons to evaluate e.g., aliasing artifacts, image sharpness and denoising levels. |
  | Deep Resolve Sharp | - Preservation of image quality (image sharpness) compared to original.
• Impact characterized by PSNR, SSIM, and perceptual loss.
• Verification and validation by visual rating and evaluation of image sharpness by intensity profile comparisons. | The impact of the network has been characterized by several quality metrics such as peak signal-to-noise ratio (PSNR), structural similarity index (SSIM), and perceptual loss. In addition, the feature has been verified and validated by inhouse tests. These tests include visual rating and an evaluation of image sharpness by intensity profile comparisons of reconstructions with and without Deep Resolve Sharp. |

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

• Deep Resolve Boost: The document doesn't explicitly state a separate "test set" size. It mentions the "Training and Validation data" which includes:
  • TSE: more than 25,000 slices
  • HASTE: pre-trained on the TSE dataset and refined with more than 10,000 HASTE slices
  • EPI Diffusion: more than 1,000,000 slices
  • Data Provenance: The data covered a broad range of body parts, contrasts, fat suppression techniques, orientations, and field strength. No specific country of origin is mentioned, but the manufacturer (Siemens Healthcare GmbH) is based in Germany, and Siemens Medical Solutions USA, Inc. is the submitter. The data was "retrospectively created from the ground truth by data manipulation and augmentation."
• Deep Resolve Sharp: The document doesn't explicitly state a separate "test set" size. It mentions "Training and Validation data" from "on more than 10,000 high resolution 2D images."
  • Data Provenance: Similar to Deep Resolve Boost, the data covered a broad range of body parts, contrasts, fat suppression techniques, orientations, and field strength. Data was "retrospectively created from the ground truth by data manipulation." No specific country of origin is mentioned.

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

Not specified. The document states that the acquired datasets "represent the ground truth." There is no mention of expert involvement in establishing ground truth for the test sets. The focus is on technical metrics (PSNR, SSIM) and "visual comparisons" or "visual rating" which implies expert review, but the number and qualifications are not provided.

4. Adjudication Method for the Test Set

Not explicitly stated. The document mentions "visual comparisons" for Deep Resolve Boost and "visual rating" for Deep Resolve Sharp. This suggests subjective human review, but no specific adjudication method (like 2+1 or 3+1 consensus) is detailed.

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 described for the AI features. The studies mentioned (sections 8 and 9) focus on evaluating the technical performance and image quality of the AI algorithms themselves, not on their impact on human reader performance.

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

Yes, standalone performance evaluation of the algorithms was conducted. The "Test Statistics and Test Results Summary" for both Deep Resolve Boost and Deep Resolve Sharp detail the evaluation of the network's impact using quantitative metrics (PSNR, SSIM, perceptual loss) and qualitative assessments ("visual comparisons," "visual rating," "intensity profile comparisons"). This represents the algorithm's performance independent of a human reader's diagnostic accuracy.

7. The Type of Ground Truth Used

The ground truth used for both Deep Resolve Boost and Deep Resolve Sharp was the acquired datasets themselves, representing the original high-quality or reference images/slices.

• For Deep Resolve Boost, input data was "retrospectively created from the ground truth by data manipulation and augmentation," including undersampling k-space lines, lowering SNR, and mirroring k-space data. The original acquired data serves as the target "ground truth" for the AI to reconstruct/denoise.
• For Deep Resolve Sharp, input data was "retrospectively created from the ground truth by data manipulation," specifically by cropping k-space data to create low-resolution input, with the original high-resolution data serving as the "output / ground truth" for training and validation.

8. The Sample Size for the Training Set

• Deep Resolve Boost:
  • TSE: more than 25,000 slices
  • HASTE: pre-trained on the TSE dataset and refined with 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

The ground truth for the training set was established as the acquired, unaltered (or minimally altered, e.g., removal of k-space lines to simulate lower quality input from high quality ground truth) raw imaging data.

• For Deep Resolve Boost: "The acquired datasets (as described above) represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation and augmentation." This implies that the original, high-quality scans were considered the ground truth, and the AI was trained to restore manipulated, lower-quality versions to this original quality.
• For Deep Resolve Sharp: "The acquired datasets represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation. 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." Similar to Boost, the original, higher-resolution scans served as the ground truth.

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 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 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 display and MR-Safe biopsy needles.

Software syngo MR E11E with Ischemic Heart Disease (HD) Workflow, when used with a gadolinium-based contrast agent (GBCA) approved for cardiac MRI (CMRI) is indicated for the acquisition and display of images of myocardial perfusion (stress, rest) and late gadolinium enhancement (LGE) during post-contrast CMRI examination in patients with known or suspected coronary artery disease (CAD).

MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with IHD Workflow are the subject devices. The Software syngo MR E11E with IHD Workflow, when used with a gadolinium-based contrast agent (GBCA) approved for CMRI, extends the capability of the cleared Cardiac Dot Engine (K121434) for post-contrast CMRI exams for patients with known or suspected coronary artery disease (CAD). Software syngo MR E11E with IHD Workflow is available for MAGNETOM Aera and MAGNETOM Skyra excluding the 24-channel configuration.

A. The cleared Cardiac Dot Engine (syngo MR D13A, K121434) helps acquisition and display of cardiac morphology and function (noncontrast CMRI).
A comprehensive post-contrast CMRI exam includes stress/rest perfusion and late gadolinium enhanced (LGE) imaging. To accomplish post-contrast CMRI imaging, basic morphologic / functional imaging (noncontrast CMRI) is required. Therefore, the cleared Cardiac Dot Engine (syngo MR D13A, K121434) is a pre-requisite to the subject devices.

B. The Cardiac Dot Engine together with the IHD Workflow and a GBCA approved for post-contrast CMRI provides for a complete (pre- and post-contrast) examination.

The primary predicate devices are modified to include a new Dot Workflow named "Ischemic Heart Disease" (IHD) Workflow for a post-contrast CMRI exam using pulse sequences already cleared in the USA (syngo MR D13A, K121434). A new Dot Workflow "Ischemic Heart Disease" is added in Cardiac Dot Engine dropdown list, under the region "heart". This Dot Workflow includes the following: six new post-contrast CMRI measurement protocols and one workflow step:

New Measurement protocols:

1. DynamicTest (test protocol for perfusion imaging without contrast agent)
2. DynamicStress (protocol for perfusion imaging under stress conditions)
3. DynamicRest (protocol for perfusion imaging under rest conditions)
4. DE overview (protocol for delayed enhancement (DE) or LGE with low spatial resolution as an overview)
5. DE_seg_high-res_LAX (protocol for DE or LGE with high spatial resolution in long axis view)
6. DE seg high-res SAX (protocol for DE or LGE with high spatial resolution in short axis view)

New workflow step:

1. Inject contrast agent. This step prompts the user to start the contrast agent injection for post-contrast CMRI exams.

This document describes the regulatory approval for the Siemens MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow. The IHD Workflow is an extension to the cleared Cardiac Dot Engine, intended for post-contrast Cardiac MRI (CMRI) exams for patients with known or suspected Coronary Artery Disease (CAD).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or quantitative performance metrics for the IHD Workflow. Instead, it refers to the efficacy results of two clinical studies (GadaCAD1 and GadaCAD2) to support the device's performance. The "acceptance criteria" can therefore be inferred as the successful demonstration of the device's ability to acquire and display myocardial perfusion and late gadolinium enhancement (LGE) images that adequately detect CAD when interpreted by qualified readers.

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

• Sample Size for Test Set: A total of 764 subjects were evaluated across two studies: 376 subjects in GadaCAD1 and 388 subjects in GadaCAD2. These subjects represent the test set for evaluating the post-gadobutrol CMRI capabilities.
• Data Provenance: The GadaCAD studies were prospectively controlled, multi-national, single-arm clinical studies. The document states that they were performed by Bayer HealthCare AG.

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

• Number of Experts: The document states that the CMRI images were "interpreted by qualified independent readers". While it doesn't specify an exact number, the use of "readers" (plural) across multi-center, multi-national studies implies multiple experts were involved in the interpretation process.
• Qualifications of Experts: The readers were described as "radiologists and cardiologists experienced in CMRI".

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1 consensus) for establishing the ground truth from the expert interpretations in the GadaCAD studies. It simply states that the images were "interpreted by qualified independent readers." The primary endpoint of the GadaCAD studies, as mentioned in the GADAVIST™ package insert, was likely the diagnostic accuracy of CMRI for CAD detection, which would have implicitly relied on these interpretations, but the specific consensus mechanism is not detailed.

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

• The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study designed to assess the improvement of human readers with AI vs. without AI assistance.
• The IHD Workflow is presented as a set of modified measurement protocols and a workflow step for image acquisition and display, extending the capabilities of the existing Cardiac Dot Engine. The clinical studies evaluated the efficacy of the imaging technique itself (using the IHD Workflow components) for CAD detection, not the comparative performance of human readers with and without AI assistance for interpretation.

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

• The document does not present a standalone performance study for an algorithm without human-in-the-loop performance.
• The IHD Workflow focuses on image acquisition and display protocols. The interpretation of these images for diagnosis still relies on "trained physicians." The clinical studies validate the acquisition and display capabilities to produce images sufficient for expert interpretation.

7. Type of Ground Truth Used

The ground truth used in the GadaCAD studies was expert consensus / clinical interpretation by qualified independent readers (radiologists and cardiologists experienced in CMRI) for the detection of CAD. The document explicitly states: "The post-gadobutrol CMRI specific acquisition protocols supported adequate detection of CAD in two multi-center, multinational clinical studies."

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. The IHD Workflow's development and validation are largely described in terms of non-clinical software verification and validation, and clinical validation using the GadaCAD studies. The GadaCAD studies served as the validation set for the device's performance, not a training set for an AI/algorithm component requiring labeled data for learning. The IHD Workflow primarily introduces new measurement protocols and a workflow step, not necessarily a machine learning algorithm that requires a distinct training set in the conventional sense.

9. How Ground Truth for the Training Set Was Established

Since no training set is explicitly mentioned or relevant for the described IHD Workflow (which consists of acquisition protocols and workflow steps, not an AI model requiring a training phase), the method for establishing ground truth for a training set is not applicable/not provided in this document.

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, 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 display and MR-Safe biopsy needles.

The mobile configuration for MAGNETOM scanners enables customers to relocate the MRI System to different locations and therefore provide imaging services to hospitals or locations where fixed installations are not possible or feasible.

For MAGNETOM Aera a mobile configuration is already available on the market with a fixed patient table. Within this premarket notification the Tim Dockable Table is being made available for the MAGNETOM Aera - Mobile Solution to enable customers to use the mobile MR Tim Dockable Table as an extension to their MRI fleet.

In order to support the addition of the Tim Dockable Table a hardware modification is necessary. A support bracket will be modified to secure the Tim Dockable Table during repositioning of the Trailer. For this modifications for the trailer manufacturers, which need to underqo certification, are adapted.

The MAGNETOM Aera - Mobile Solution with Tim Dockable Table described within this submission does not contain any software modifications.

• Workflow Release of Tim Dockable Table to the MAGNETOM Aera - Mobile Solution to enable customers to use the mobile MR table as an extension to their MRI fleet
• Modification of an existing support bracket to secure the Tim Dockable Hardware Table during repositioning of the Trailer
• The MAGNETOM Aera Mobile Solution with Tim Dockable Table Software described within this submission does not contain any software modification compared to the predicate device.

The provided text describes a 510(k) submission for a device called "MAGNETOM Aera - Mobile Solution with Tim Dockable Table." However, it is not an AI/ML medical device submission. This submission is for a hardware modification to an existing Magnetic Resonance Diagnostic Device (MRDD). The key modification is the addition of a "Tim Dockable Table" to a mobile MRI unit and a complementary support bracket to secure it during transport.

Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML medical device. Specifically, it lacks:

• A table of acceptance criteria and reported device performance (for an AI/ML algorithm).
• Details on sample sizes for test sets, data provenance, or ground truth establishment for AI/ML.
• Information on expert reviewers, adjudication methods, or MRMC studies.
• Mention of standalone algorithm performance or training set details for an AI/ML model.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (MAGNETOM Aera with syngo MR E11C-AP01) through:

• Nonclinical Tests: General Performance Testing, Acoustic Noise Testing, and Environmental Testing (Weather Influences).
• Safety and Effectiveness: Compliance with standards like ISO 14971 (risk management), IEC 60601-1 series (electrical/mechanical risk), IEC 62304 (software development, though it explicitly states no software modifications), and NEMA DICOM standards.

The document explicitly states: "No clinical tests were conducted to support substantial equivalence for the subject device." and "The MAGNETOM Aera - Mobile Solution with Tim Dockable Table described within this submission does not contain any software modifications." It goes on to clarify this again: "The MAGNETOM Aera Mobile Solution with Tim Dockable Table Software described within this submission does not contain any software modification compared to the predicate device."

Since this is a submission for a hardware modification to a conventional medical device, and not an AI/ML device, the requested information cannot be extracted from this document.

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 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 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.

The application package AP01, "Implant Suite" for MAGNETOM Aera, enables diagnostic imaging for patients with MR Conditional active and passive implants. Three different Fixed Parameter Options (FPO), Scan Limits 1, 2, and 3, provide conditional implant scan limitations as shown below:

| Fixed Parameter
Options | B1+ peak | B1+ rms | WB SAR | dB/dt
peak | dB/dt rms | Slew rate |
|----------------------------|----------|----------|------------|---------------|-----------|----------------|
| Scan Limits 1 | - | - | ≤ 2 W/kg | - | - | ≤ 200
T/m/s |
| Scan Limits 2 | - | ≤ 2.0 μT | ≤ 0.8 W/kg | - | - | ≤ 200
T/m/s |
| Scan Limits 3 | ≤ 30 μT | ≤ 2.0 μT | ≤ 0.8 W/kg | ≤ 50 T/s | ≤ 56 T/s | ≤ 125
T/m/s |

Without a scan limitation selected, the subject device operates identically to the predicate device. The AP01 application package, "Implant Suite", is an optional feature.

With application package AP01, "Implant Suite" for MAGNETOM Aera, the following changes are introduced:

| Hardware | Modified
Hardware | - Additional segregated control path to safely
switch-off the gradient power in case the limits are
reached during a scan

• Additional supply-voltage supervisions in the
  gradient amplifier
• Additional measures to ensure permanent active
  RF sensor data communication
• Additional segregated TX- switch-off path (TSO
  box)
• New computer hardware for MRAWP and MRWP
  due to obsolescence |
  |----------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
  | Software | New Features
  and Applications | - Implant Suite (syngo MR E11C-AP01)
  Including:
• New Online Patient Safety supervision (OPS)
  interface
• New safe reaction (switch-off) path for when
  implant related limits are exceeded
• Extended look-ahead functionality (prediction)
  to avoid starting sequences that could
  potentially exceed implant-related limits
• New internal supervision to detect latent
  failures in the control path
• New Implant Suite UI (IUI)
• New means to control coil usage
• Adapted pulse sequences with restricted
  operation mode |

The provided text describes a 510(k) premarket notification for a medical device, the MAGNETOM Aera with syngo MR E11C-AP01 software, which is a Magnetic Resonance Diagnostic Device (MRDD). The submission aims to demonstrate substantial equivalence to a predicate device (MAGNETOM Aera with syngo MR E11C-AP04 software, K173592).

The core of the submission revolves around the new "Implant Suite" feature, which enables diagnostic imaging for patients with MR Conditional active and passive implants by implementing specific scan limitations.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical performance target format (e.g., sensitivity, specificity, or image quality scores against a baseline). Instead, the acceptance criteria are implicitly defined by the successful verification of the new features and limitations implemented for safe scanning of patients with MR Conditional implants, and the demonstration of equivalent safety and performance to the predicate device.

The reported device performance is therefore described in terms of its ability to implement and adhere to these new limitations and to maintain image quality.

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 any of the performance tests (image quality assessments, FPO verification, or software V&V).
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that "clinical images were provided," suggesting real-world data, but details are lacking.

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

• The document states that "clinical images were provided to support the imaging performance of the device when using the limitations of the new 'Implant Suite' feature." It also mentions that images "when interpreted by a trained physician, yield information that may assist in diagnosis." However, it does not specify the number of experts, their qualifications (e.g., years of experience as a radiologist), or their role in establishing a formal ground truth for the test set used in the performance evaluation.

4. Adjudication Method for the Test Set:

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for interpreting the clinical images or evaluating the performance of the device.

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

• The document explicitly states: "No clinical tests were conducted to support substantial equivalence for the subject device." Therefore, no MRMC comparative effectiveness study involving human readers with and without AI assistance was performed or reported. The regulatory submission relies on non-clinical tests and demonstration of equivalent technical characteristics for safety and performance to the predicate device.

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

• This device is an MR scanner with updated software and hardware, not an AI algorithm that acts as a standalone diagnostic tool. The "Implant Suite" is a feature that modifies the scanner's operational parameters. Therefore, a standalone algorithm-only performance study (as would be typical for an AI-based diagnostic tool) is not applicable here and was not reported. The "software verification and validation testing" evaluates the correct functioning of the software features, including the new safety mechanisms, but not in the context of a standalone diagnostic algorithm.

7. Type of Ground Truth Used:

• For the non-clinical tests (FPO verification, software V&V), the "ground truth" would be the expected behavior based on engineering specifications and safety requirements.
• For the "clinical images," the implicit ground truth for evaluating "imaging performance" would likely be the diagnostic interpretation by a trained physician, but no formal process for establishing this ground truth is described. It is not pathology, outcomes data, or an expert consensus process in the way these are typically defined for diagnostic accuracy studies.

8. Sample Size for the Training Set:

• The document does not describe the development of a machine learning or AI model with a distinct "training set." The changes are primarily software modifications for safety features and operational limitations, along with associated hardware changes. Therefore, the concept of a "training set" in the context of machine learning is not directly applicable to this submission.

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

• As the device's modifications are not described as involving machine learning from a training set, the question of how ground truth for a training set was established is not relevant to this 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.

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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 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 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.

MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C Software is cleared with K153343. To address the Compressed Sensing Cardiac Cine and the modified Software Features described in this Premarket Notification Siemens intends to make the Software Application Package syngo MR E11C - AP02 available to the MAGNETOM Aera and Skyra.

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

• . MAGNETOM Aera,
• MAGNETOM Skyra .

The additional Options for the MR Scanner Software syngo MR E11C include a new feature with a new 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 describes a 510(k) premarket notification for Siemens Medical Solutions USA, Inc.'s MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software. This document is a summary of the safety and effectiveness information supporting substantial equivalence to a predicate device.

However, the document specifically states: "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."

This means that the information requested regarding acceptance criteria and a study proving the device meets these criteria (including details on sample size, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details) is not available in this document because a clinical study of this nature was not performed.

The substantial equivalence argument is based on non-clinical tests (image quality assessments, software verification and validation, and demonstrating similar technological characteristics to the predicate device) rather than a comparative clinical study.

Therefore, I cannot provide a detailed answer to your request based on the provided text, as the specific clinical study details you're asking for were explicitly stated as not having been conducted.

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The MAGNETOM systems are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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 systems described above 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.

The subject device, syngo MR E11C system software, is being made available for the following MAGNETOM MR Systems:

• MAGNETOM Aera,
• MAGNETOM Skyra, ●
• MAGNETOM Prisma and
• MAGNETOM Prisma™ ●

The syngo MR E11C SW includes new sequences. new features and minor modifications of already existing features.

The provided text describes a 510(k) premarket notification for new software (syngo MR E11C) for Siemens MAGNETOM MR systems. However, it does not contain the detailed information required to answer all aspects of your request regarding acceptance criteria and a study proving device performance as typically expected for AI/ML device submissions.

This submission is for a software update to existing Magnetic Resonance Diagnostic Devices (MRDDs), and the focus is on demonstrating substantial equivalence to previously cleared predicate devices. The "study" mentioned is primarily non-clinical performance testing and software verification/validation, rather than a clinical study with acceptance criteria for specific diagnostic outcomes.

Here's an attempt to extract and infer information based on the provided text, highlighting what is present and what is missing:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for diagnostic performance or specific metrics. Instead, it relies on demonstrating that the new software's features perform "as intended" and maintain "equivalent safety and performance profile" compared to predicate devices.

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

• Test Set Sample Size: "Sample clinical images were taken for particular new and modified sequences." The specific number or characteristics of these images (sample size) is not provided.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "sample clinical images," suggesting clinical data was used for assessment.

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. The document states "Image quality assessments... were completed," but does not detail who performed these assessments or how ground truth was established for them. For a diagnostic device, interpretation by a "trained physician" is mentioned in the Indications for Use, but this is a general statement about the device's usage, not specific to the assessment of the new software.

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

• This information is not provided.

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, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests were conducted to support the subject device and the substantial equivalence argument..."
• This submission is not for an AI-enhanced diagnostic tool in the sense of providing automated interpretations or assisting human readers in a measurable way with specific diagnostic outcomes. It's an update to MR imaging acquisition software. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" does not apply in this context.

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

• The device is a Magnetic Resonance Diagnostic Device (MRDD) software update. Its output is images and/or spectra that are "interpreted by a trained physician" to "assist in diagnosis." As such, it is inherently a human-in-the-loop system. The non-clinical tests involved "Image quality assessments" and "Acoustic noise measurements," which are performance evaluations of the acquisition capabilities, not a standalone diagnostic interpretation by the algorithm.
• Therefore, a standalone diagnostic performance evaluation (algorithm only) in the context of providing a diagnosis was not performed or described.

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

• For "Image quality assessments," the type of ground truth is not explicitly stated. It can be inferred that it would likely involve visual assessment by experts against what is considered normal or expected for an MR image, potentially comparing to images acquired with predicate software or known anatomical/pathological features. However, specific ground truth methods like pathology or long-term outcomes data are not mentioned.

8. The sample size for the training set

• The document does not mention a separate training set or details about its size. This submission focuses on software changes and their verification, not on the development of a new AI model that requires a distinct training phase.

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

• Since a separate training set is not mentioned, the method for establishing its ground truth is also not provided.

Summary of what's present and what's missing:

This 510(k) submission primarily focuses on demonstrating that new software features (like quiet diffusion imaging, improved fast TSE, simultaneous multi-slice imaging, and a short acquisition time brain examination protocol) for existing MR systems maintain the fundamental technological characteristics, safety, and effectiveness of predicate devices. The "study" here is a series of non-clinical tests (image quality review, acoustic noise measurements, software V&V) rather than a clinical trial measuring diagnostic accuracy or reader performance. The level of detail you're asking for, especially concerning clinical study design elements like sample size, expert reader qualifications, adjudication methods, and ground truth establishment for diagnostic output, is typically found in submissions for AI/ML diagnostic tools that directly interpret images or provide diagnostic assistance, which is not the primary claim of this particular device update.

Ask a specific question about this device

The MAGNETOM systems are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and or spectra, and that display 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 the physical parameters derived from the inages and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis.

The MAGNETOM systems described above 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.

The subject device, synqo MR E11B system software, is being made available for the following MAGNETOM MR Systems:

• MAGNETOM Aera (24-channel configuration), .
• MAGNETOM Avanto™ ●
• MAGNETOM Skyra™, ●
• . MAGNETOM Prisma and
• . MAGNETOM Prisma™

Two new coils, Body 30/60 and Body 6 long, will be available for the subject device systems. The feature FREEZEit will be extended to other body regions. In addition to the abdomen region, FREEZEit will be extended to other regions such as the head, head and neck, pelvis, and chest region. . The syngo MR E11B SW also includes new sequences as well as minor modifications of already existing features. A high level summary of the new sequences can be viewed below:

DSI
With software version syngo MR E11B Siemens offers DSI for MAGNETOM Prisma, Prismall and Skyra" systems. The DSI option allows diffusion-weighted images to be acquired according to a DSI-compatible q-space sampling scheme.

QISS evaluation
QISS (Quiescent-Interval Single-Shot) MR Angiography is a technique for non-contrastenhanced MR Angiography (non-CEMRA) that is particularly suited for examinations of patients with PAD. Since patients with PAD may also suffer from additional impairments such as renal dysfunction, the administration of contrast agent may often be unadvisable in this patient group. Siemens provides a manageable and optimized QISS workflow for imaging peripheral arteries, which can be easily adapted by the customer based on the patient's needs.

A new "Dot Engine" is provided to ease MRI acquisitions in Radiation Therapy.

RT Dot Engine
RT Dot Engine is a new Dot Engine for aiding in Radiation Therapy planning. The RT Dot Engine does not provide new functionality, but collects and displays existing system information for the user. The RT Dot Engine comprises existing protocols, enhanced with the RT Planning Dot Add-in and the "MPR Planning" interaction step. The RT (Radiation Therapy) Dot Engine is used to ease MRI acquisitions of the head and the head/neck region with stereotactic frames or mask-based fixation techniques. RT Dot Engine is a workflow solution for acquiring MR images intended to aid in Radiation Therapy Planning. RT Dot engine helps streamline acquisition of MR images to be used along with any RT planning software that uses MR images in addition to CT images.

The provided text is a 510(k) summary for a medical device and does not contain the level of detail typically found in a clinical study report regarding acceptance criteria and performance studies for an AI-powered device.

This document describes a Magnetic Resonance Diagnostic Device (MRDD) software upgrade (syngo MR E11B) for existing Siemens MAGNETOM MR systems. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria for a novel AI algorithm.

Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, ground truth establishment, and expert adjudication are not present in this type of regulatory document.

However, I can extract the information that is available and clarify what is missing based on the context of a 510(k) submission for an MRI system software upgrade:

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

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: Not explicitly stated as a formal "test set" in the context of an algorithm evaluation. The document mentions "clinical images were provided to support the new coils as well as the new software features," but the number of images or patients is not specified.
• Data Provenance: Not specified. Given the nature of a 510(k) for a software upgrade to an MRI machine, the "clinical images" likely came from internal testing or routine clinical acquisitions.

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)

• The document states "These images and the physical parameters derived from the images and/or spectra when interpreted by a trained physician, yield information that may assist in diagnosis." However, it does not specify the number or qualifications of experts used to establish a formal ground truth for testing the software's performance, as this is an MRI system software upgrade, not a diagnostic AI algorithm.

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

• No adjudication method is mentioned.

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 conducted or reported. This device is a software upgrade for an MRI system, not an AI diagnostic assistant tool.

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

• Not applicable in the context of this device. The software "produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and or spectra," which are then "interpreted by a trained physician." It is not a standalone diagnostic algorithm.

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

• For the nonclinical tests (SNR, uniformity, heating, acoustic noise), the "ground truth" would be established by technical specifications and phantom measurements.
• For image quality assessments, a "ground truth" (e.g., against specific diagnostic findings) is not detailed. The assessment likely involved expert review of image quality (e.g., resolution, artifact reduction, diagnostic clarity) rather than a comparison to a definitive clinical ground truth established by pathology or long-term outcomes. The primary focus is on demonstrating that the images produced are diagnostically acceptable and equivalent to the predicate.

8. The sample size for the training set

• Not applicable. This document describes a software upgrade for an MRI system, which includes new sequences and features (e.g., DSI, QISS, RT Dot Engine). It is not an AI algorithm that would typically have a "training set" in the machine learning sense. The software development follows traditional engineering and quality assurance practices.

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

• Not applicable, as no training set (in the AI/ML context) is mentioned for this device.

Ask a specific question about this device

The MAGNETOM systems described above 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 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.

The MAGNETOM systems described above 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.

The subject device, software syngo MR E11A for MAGNETOM Aera and MAGNETOM Skyra offers two new applications, LiverLab (an application of non-invasive liver evaluation) and MyoMaps (an application designed to provide a means to generate pixel maps for myocardial MR relaxation times). In addition, software syngo MR E11A makes the Dot Cockpit available for the user to modify and create Siemens Dot Engine workflows in a very intuitive way which supplements some of the support of an application specialist. The software syngo MR E11A also includes new and modified sequences as well as minor modifications of already existing features. In additional coils are offered and some hardware components have been modified.

Siemens Medical Solutions, USA Inc., intends to market MAGNETOM Aera and MAGNETOM Skyra with new software, syngo MR E11A. While syngo MR E11A offers additional capabilities with respect to the predicate device, the MAGNETOM Aera and MAGNETOM Skyra have the same technological characteristics as the predicate device (K121434; Cleared November, 5, 2012).

Furthermore, Siemens Medical Solutions, USA Inc., intends to market a new configuration of the MAGNETOM Skyra with 24 receive channels with software syngo MR E11A.

The MAGNETOM Aera and MAGNETOM Skyra will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Aera and MAGNETOM Skyra systems. The new MAGNETOM Skyra configuration with 24 receive channels will be offered as an ex-factory option (new production).

This FDA 510(k) summary describes a new software version (syngo MR E11A) for existing Siemens MAGNETOM Aera and MAGNETOM Skyra MRI systems. The primary focus of the document is to demonstrate substantial equivalence to previous versions and other cleared devices, rather than establishing new acceptance criteria for a novel device.

Therefore, the requested information regarding acceptance criteria, device performance, and specific study details (like sample size for test sets, expert qualifications, and adjudication methods) is largely not present for the overall system or its new features as this is an equivalence submission. The closest equivalent to "acceptance criteria" are the results of performance tests demonstrating the device performs as intended and is "substantially equivalent."

However, I can extract the available information regarding testing for the new features:

1. Table of Acceptance Criteria and Reported Device Performance

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

• MyoMaps Comparison Study:
  • Sample Size: 100 persons.
  • Data Provenance: Not specified, but involved "volunteers."
• LiverLab Validation:
  • Sample Size: Not specified beyond "volunteer" and "phantom scans."
  • Data Provenance: Not specified, beyond "volunteer" and "phantom scans" and "synthetic raw data."
• New Coils, Sequences, Algorithms, Acoustic Noise: Sample sizes not specified; phantom testing mentioned.
• Clinical tests (overall device): No clinical tests were conducted to support the substantial equivalence argument beyond the provision of clinical images to support new coils and software features.

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 document states that the images and spectra, "when interpreted by a trained physician, yield information that may assist in diagnosis." However, for validation studies, the specifics of expert involvement or ground truth establishment are not detailed.

4. Adjudication method 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

• A MRMC study comparing human readers with and without AI assistance was not mentioned or performed as part of this submission. The "MyoMaps" feature was compared to "Thalassaemia Tools," which is a comparison of two tools, not a human-AI comparison.

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

• The document describes "LiverLab" validation using "volunteer as well as phantom scans, and synthetic raw data" and "MyoMaps" being "tested on volunteers." This suggests standalone performance evaluation for these specific features. However, detailed metrics of standalone performance are not provided, only that the "results... demonstrate that the device performs as intended."

7. The type of ground truth used

• MyoMaps: The comparison was against "Thalassaemia Tools." For the "volunteers" testing, the method of establishing ground truth for myocardial MR relaxation times beyond direct measurement is not specified.
• LiverLab: Validation involved "volunteer as well as phantom scans, and synthetic raw data." The ground truth for phantom scans would be known parameters. For volunteer scans, the ground truth source for liver evaluation is not explicitly stated (e.g., biopsy results, clinical diagnosis).
• For other features (coils, sequences), the ground truth generally relies on physical measurements and expected image properties.

8. The sample size for the training set

• This information is not provided in the document. The submission focuses on verification and validation of implemented features rather than detailing the development or training of algorithms.

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

• This information is not provided in the document. Given that details on a training set are absent, the method for establishing its ground truth is also not mentioned.

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