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LiverMultiScan (LMSv3) is indicated for use as a magnetic device software application for noninvasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.

LiverMultiScan (LMSv3) is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from compatible MR Systems, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.

LiverMultiScan (LMSv3) provides a number of tools, such as automated liver segmentation and region of interest (ROI) placements, to be used for the assessment of selected regions of an image. Quantitative assessment of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. PDFF may optionally be computed using the LMS IDEAL or three-point Dixon methodology.

These images and the physical parameters derived from the images, when interpreted by a trained clinician, yield information that may assist in diagnosis.

LiverMultiScan (LMSv3) is a standalone software application for displaying 2D Magnetic Resonance (MR) medical image data acquired from compatible MR Scanners. LiverMultiScan runs on general-purpose workstations with a colour monitor, keyboard and mouse.

The main functionality of LiverMultiScan (LMSv3) includes:

• Reading DICOM 3.0 compliant datasets stored on workstations, and display of the data acquisition information
• Post-processing of MRI data to generate parametric maps of Proton Density Fat Fraction PDFF), T2*, T1 and ironcorrected T1 (cT1) of the liver.
• Quantification, and calculation of PDFF, T2* and cT1 metrics using tools such as automatic liver segmentation and ROI (region of interest) placement.
• Generation of a summary report demonstrating the quantitative assessment results of fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with corresponding reported performance for specific metrics like sensitivity, specificity, accuracy, etc., as one might expect for a diagnostic device. Instead, the performance testing focuses on the accuracy, repeatability, reproducibility, and inter-/intra-operator variability of quantitative measurements, and particularly on demonstrating substantial equivalence to a predicate device (LMSv2).

The acceptance criteria are implicitly defined by the reported performance ranges and the conclusion that the device performs "as well as its predicate" and that "all the testing results are well within the acceptance criteria."

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

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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 images, spectroscopic images and that displays the internal structure and/or function of the head, body, or extremittes. Other physical parameters derived from the images and or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These mages and or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

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

MAGNETOM Vida with software syngo MR XA10A is similar to the previous cleared predicate device MAGNETOM Skyra with syngo MR E11C (K153343) but includes new and modified hardware and software compared to MAGNETOM Skyra.

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

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

Acceptance Criteria and Reported Device Performance

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

Table of Acceptance Criteria and Reported Device Performance:

Study Information

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

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

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

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

3. Adjudication Method for the Test Set:

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

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

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

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

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

6. Type of Ground Truth Used:

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

7. Sample Size for the Training Set:

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

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

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

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The MAGNETOM Spectra 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.

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.

The subject device, Software syngo MR E11M for the MAGNETOM Spectra, is the latest software version for the Siemens MR MAGNETOM Spectra. It is modified based on the software version syngo MR E11A, which was cleared with K141977 on November 19, 2014. The software functionality and applications are based on syngo MR E11A except in technical instances where adaptations were needed to support the system specific hardware and optimize the sequence/protocols. System tests validating the aforementioned adapations are provided in Appendix 9.

Listed below are the hardware updates to the MAGNETOM Spectra systems with software syngo MR E11M:

• · two new coils
  • o Breast 18 (cleared with K133435 on December 12, 2013)
  • o Pediatric 16 (cleared with K140998 on July 11, 2014)
• a modified MARS(Measurement and Reconstruction System) .
• an updated MRAWP/MRWP(Syngo Acquisition Workplace/ Syngo . Workplace) based on the new host platform
• . minor hardware changes to the transmit unit

The MAGNETOM Spectra with software version syngo MR E11M will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Spectra systems.

The provided text does NOT describe acceptance criteria for a device, nor does it detail a study that proves the device meets specific acceptance criteria in the way envisioned by the request.

Instead, this document is a 510(k) Premarket Notification from the FDA to Siemens Medical Solutions USA, Inc., concerning the MAGNETOM Spectra, a magnetic resonance diagnostic device. The purpose of a 510(k) submission is to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device, rather than to prove it meets specific performance acceptance criteria through clinical studies.

Here's an analysis based on the available information, highlighting what is and is not present:

Missing Information:

• Acceptance Criteria Table: The document does not provide a table of acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio targets).
• Reported Device Performance against Acceptance Criteria: Since no acceptance criteria are listed for diagnostic performance, there's no data reported against them. The document mentions nonclinical tests for SNR, image uniformity, and heating for new coils, and verification/validation for other software features, but doesn't provide specific numerical results or target values.
• Sample Size for Test Set and Data Provenance: No test set (clinical or otherwise for diagnostic efficacy) is described, so sample size, country of origin, or retrospective/prospective nature of data are not detailed.
• Number of Experts and Qualifications for Ground Truth: Not applicable, as there's no diagnostic performance study with ground truth establishment described.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or conducted.
• Standalone Performance Study: No standalone diagnostic performance study (algorithm only) is described. The device is an MRI system, not an AI algorithm.
• Type of Ground Truth Used: Not applicable for diagnostic performance as no such study is presented.
• Sample Size for Training Set: Not applicable, as this is an MRI system and software update, not an AI model trained on a dataset.
• How Ground Truth for Training Set was Established: Not applicable.

**Information that is available: **

The document focuses on demonstrating substantial equivalence to predicate devices for the MAGNETOM Spectra with software syngo MR E11M.

• Device Description: The MAGNETOM Spectra with software syngo MR E11M is described as the latest software version for the Siemens MR MAGNETOM Spectra, modified from syngo MR E11A. It includes two new coils (Breast 18 and Pediatric 16), a modified MARS (Measurement and Reconstruction System), an updated MRAWP/MRWP (Syngo Acquisition Workplace/Syngo Workplace) and minor hardware changes.
• Nonclinical Tests:
  • The coils were tested for SNR (Signal-to-Noise Ratio), image uniformity, and heating.
  • All other software features were verified and validated.
  • The document states these tests "demonstrate that the device performs as intended." However, no specific quantitative results or acceptance thresholds are provided.
• Clinical Tests: "No clinical tests were conducted to support the subject device and the substantial equivalence argument, however clinical images were provided to support the new coils of the subject device." This explicitly states that no diagnostic clinical study was performed for this 510(k).
• Ground Truth (for New Coils): While not explicitly stated as "ground truth," the mention of "clinical images provided to support the new coils" implies that the performance of these coils was visually assessed by experts using clinical data, likely within internal validation processes, to ensure image quality was acceptable. However, the details of this assessment are not provided.
• Predicates:
  • Primary Predicate: MAGNETOM Spectra with syngo MR D12 (K121160)
  • Secondary Predicate: Siemens MAGNETOM Skyra with syngo MR E11A (K141977)
• Regulatory Basis: The FDA's review concludes that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as the predicate, or if it has different technological characteristics, it does not raise new questions of safety or effectiveness.

In summary, the provided document is a regulatory clearance letter and 510(k) summary, not a study report detailing performance against specific acceptance criteria for diagnostic accuracy or efficacy. It relies on non-clinical testing and substantial equivalence to legally marketed predicates for device clearance.

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