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

MAGMETOM Vida, MAGNETOM Lumina, and MAGNETOM Vida Fit with software synqo MR XA20A include new and modified hardware and software compared to the predicate device, MAGNETOM Vida with syngo MR XA11B. A high level summary of the hardware and software is provided below:

Hardware: Computer, Coils (BM Body 18)

Software Features and Applications: SMS for TSE DIXON, GOLiver, Angio TOF with Compressed Sensing (CS), RT Respiratory self-gating for FL3D VIBE, SMS for RESOLVE and QDWI, SPACE with Compressed Sensing (CS), i SEMAC, TSE_MDME, TSE and GRE with Inline Motion Correction, EP SEG PHS, GRE PHS, GRE_Proj, GOKnee2D, BEAT_interactive, EP2D_SE_MRE, ZOOMit DWI, SPACE Flair Improvements, External Phase Correction Scan for EPI Diffusion, MR Breast Biopsy Workflow improvements, GOBrain / GOBrain+

Software / Platform: Dot Cockpit, i Access-i, Table positioning mode

Other Modifications and / or Minor Changes: MAGNETOM Vida Fit, i BM Body 12, Body 18, UltraFlex Large 18, UltraFlex Small 18, Broad band / narrow band online supervision, LiverLab Dot Engine - debundling

The Siemens Medical Solutions USA, Inc. 510(k) submission for the MAGNETOM Vida, MAGNETOM Lumina, and MAGNETOM Vida Fit with software syngo MR XA20A and new hardware (BM Body 18 Coil) does not include a study to determine specific acceptance criteria for device performance. Instead, the submission relies on non-clinical tests to demonstrate substantial equivalence to a predicate device (MAGNETOM Vida with syngo MR XA11B).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide explicit acceptance criteria with quantitative targets for the device's performance in terms of diagnostic accuracy, sensitivity, specificity, or other clinical metrics. The "device performance" reported is largely in the context of demonstrating equivalence through image quality assessments and conformance to standards.

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

The submission does not specify a distinct "test set" in the context of a clinical study for measuring diagnostic performance. For image quality assessments:

• Sample size: Not explicitly stated. The document refers to "sample clinical images" and "comparison images."
• Data provenance: Not specified. It doesn't mention the country of origin or whether the images were retrospective or prospective.

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

Not applicable, as no formal clinical study with a defined test set and ground truth establishment by experts for diagnostic evaluation is described. The "interpretation by a trained physician" is mentioned in the Indications for Use, which refers to the end-user clinical interpretation of the images, not the establishment of ground truth for a study.

4. Adjudication Method for the Test Set:

Not applicable, as no formal clinical study with a defined test set and expert adjudication is described.

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

No MRMC study was performed or reported in this submission to evaluate the effectiveness of human readers with vs. without AI assistance. The submission describes improvements to an MR diagnostic device and its software, not an AI-assisted diagnostic tool.

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

Not applicable. This submission focuses on improvements to an MR imaging system and its software features, not a standalone AI algorithm for diagnosis. The device's output (images and spectra) is explicitly stated to require interpretation by a trained physician.

7. Type of Ground Truth Used:

Ground truth, in the context of diagnostic accuracy for a clinical study, was not used in this submission. The assessments focused on technical performance, image quality, and compliance with standards, often by comparing the new features/hardware to the predicate device or existing functionalities.

8. Sample Size for the Training Set:

Not applicable. The submission does not describe an AI/machine learning algorithm that requires a training set in the typical sense of a diagnostic AI product. The software updates are improvements to the MR imaging system itself, which do not inherently involve a "training set" for an AI model to learn from.

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

Not applicable, as there is no described training set or AI model in this context.

Summary of the Study:

The submission highlights non-clinical performance testing and refers to clinical publications for specific features. The "study" described is primarily a set of engineering and verification/validation tests to demonstrate that the new hardware (BM Body 18 coil) and software features (e.g., SMS for TSE DIXON, GOLiver, Angio TOF with Compressed Sensing, RT Respiratory self-gating) perform as intended and do not raise new questions of safety or effectiveness compared to the predicate device.

The non-clinical tests included:

• Sample clinical images with image quality assessments (sometimes compared to predicate device features).
• Performance bench tests for hardware.
• Software verification and validation (following FDA guidance).
• Biocompatibility testing (ISO 10993-1).
• Electrical, mechanical, structural, and related system safety tests (AAMI/ANSI ES60601-1, IEC 60601-2-33).
• Electrical safety and electromagnetic compatibility (EMC) tests (IEC 60601-1-2).

The conclusion of these tests was that the subject devices perform as intended and are substantially equivalent to the predicate device. No clinical studies demonstrating diagnostic accuracy or changes in human reader performance were part of this 510(k) submission.

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

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 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 displays and MR Safe biopsy needles.

Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.

The subject device, MAGNETOM Vida, is an MR system. The software syngo MR XA10A is the latest software for the Siemens MAGNETOM Vida and includes software sequences, applications, coils and other hardware for the MAGNETOM scanner. The software sequences, applications, coils and other hardware were previously cleared with K170396.

MAGNETOM Vida will be offered ex-factory (new production) with software syngo MR XA10A and Compressed Sensing GRASP-VIBE. Installed MAGNETOM Vida systems can be updated by activating the blocked license.

This filing describes the new imaging feature intended to be used with the MAGNETOM Vida. Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.

The provided text describes a 510(k) premarket notification for the Siemens MAGNETOM Vida with Compressed Sensing GRASP-VIBE. The document asserts substantial equivalence to a predicate device and does not detail specific acceptance criteria or a comprehensive study proving the device meets them in the way clinical trials typically do. Instead, it relies on demonstrating that the new feature does not introduce new safety or effectiveness concerns.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not explicitly addressed or applicable in the context of this 510(k) submission, which focuses on device modifications and substantial equivalence to an already cleared predicate.

However, based on the limited information available, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria for image quality or clinical performance that would typically be found in a clinical study report. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device through non-clinical testing and qualitative assessment of sample clinical images.

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

• Sample Size: Not explicitly stated for a dedicated clinical "test set." The document mentions "sample clinical images" were included in the determination of substantial equivalence, but not the number of images or patients.
• Data Provenance: Not specified. Given it's a Siemens product, it's likely international data, but no country of origin is mentioned. The type of data (retrospective or prospective) is also not specified for these "sample clinical images."

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 that the images and physical parameters, "when interpreted by a trained physician yield information that may assist in diagnosis." For the "sample clinical images" used, it does not specify how many experts reviewed them nor their qualifications or the process of establishing ground truth.

4. Adjudication Method for the Test Set

• Not specified. This level of detail is typically not included in a 510(k) summary focused on substantial equivalence through non-clinical data and general claims.

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. This submission focuses on the performance of the device itself (specifically the new imaging feature) in relation to a predicate device, not on comparing human reader performance with or without the device's assistance.

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

• The document implies a standalone assessment of the new imaging feature's technical performance. It states: "A comparison of the functionality was performed between the new feature and the reference device feature by detailed simulations with a numerical phantom." This indicates an algorithm-only evaluation for technical characteristics, though not a clinical standalone performance study in the sense of diagnostic accuracy.

7. The Type of Ground Truth Used

• For the "detailed simulations with a numerical phantom," the ground truth would be the known properties of the numerical phantom.
• For the "sample clinical images," the type of ground truth is not explicitly stated. However, medical image interpretation typically relies on expert consensus, clinical follow-up, or pathology reports for ground truth in diagnostic accuracy studies. This document only mentions "interpretation by a trained physician" assisting in diagnosis, without specifying how ground truth was established for comparison.

8. The Sample Size for the Training Set

• Not applicable/mentioned. This is a 510(k) submission for an MRI system and its software feature, not a machine learning algorithm that underwent a separate training phase with a distinct training set. The "Compressed Sensing GRASP-VIBE" is a technical imaging feature, not an AI diagnostic algorithm in the typical sense that would require a ground-truthed training set for learning.

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

• Not applicable/mentioned, as there is no indication of a "training set" in the context of an AI algorithm learning from data.

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.

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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