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LiverMultiScan v5 (LMSv5) is indicated for use as a magnetic resonance diagnostic 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.

LMSv5 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.

LMSv5 provides several 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 includes the determination of triglyceride fat fraction in the liver (PDFF), T2*, LIC (Liver Iron Concentration) and iron corrected T1 (cT1) measurements.

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

LiverMultiScan v5 (LMSv5) is a standalone software device. The LiverMultiScan v5 device is to assist a trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (a patient visit).

LiverMultiScan is a post-processing software device, a trained operator uses tools within the device interface to quantify liver tissue characteristics from parametric maps. LiverMultiScan v5 includes automatic processing functionality based on machine-learning to assist in the quantification of metrics during analysis, such as automatic artefact detection and automatic segmentation of the liver. A summary report from the analysis conducted is generated for interpretation by a clinician.

LiverMultiScan v5 is not intended to replace the established procedures for the assessment of a patient's liver health by a clinician, providing many opportunities for competent human intervention in the clinical care of patients.

The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of clinical care, patients with clinical symptoms or risk factors which may indicate liver disease. The interpreting clinician needs to take into consideration the device's limitations and accuracy during clinical interpretation.

Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan v5 metrics, may contribute to a diagnostic decision.

LiverMultiScan v5 is not a computer-aided diagnostic device and can only present imaging information which must be interpreted by a qualified clinician. LiverMultiScan v5 is an aid to diagnosis and treatment decisions remain the responsibility of the clinician.

Here's an analysis of the acceptance criteria and study information for LiverMultiScan v5 (LMSv5) based on the provided text, structured according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided FDA 510(k) summary document does not explicitly list quantitative acceptance criteria in a dedicated table format. Instead, it states that "All product specifications were verified and the overall ability of the product to meet user needs was validated." and "The accuracy and precision of device measurements was assessed using purpose-built phantoms...". It also mentions "The performance testing conducted demonstrates that LiverMultiScan v5 is at least as safe and effective as the predicate devices."

While specific numerical acceptance criteria (e.g., "PDFF accuracy must be within X%", "LIC precision must be within Y%") are not detailed in this public document, the general acceptance can be inferred from the statement that the device meets safety and effectiveness standards comparable to its predicates. The performance claims are therefore that the device provides accurate and precise measurements of liver triglyceride fat fraction (PDFF), T2*, Liver Iron Concentration (LIC), and iron-corrected T1 (cT1), comparable to or exceeding its predicate devices.

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

• Test Set Sample Size: The document mentions "in-vivo volunteer data was used" for assessing precision across supported scanners and for inter/intra-operator variability. It also refers to "purpose-built phantoms" for accuracy and precision of device measurements. Specific numerical sample sizes for either phantom or in-vivo data are not provided in this summary document.
• Data Provenance: Not explicitly stated from which country the "in-vivo volunteer data" originated. It is generally understood that studies supporting medical device submissions to the FDA can involve multinational data, but this document does not specify. The data would be prospective if volunteers were recruited and scanned specifically for this validation, or retrospective if existing de-identified patient data was used. The document does not clarify this.

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

This document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. For quantitative MRI biomarkers like PDFF, T2*, cT1, and LIC, ground truth is typically established through direct physical measurements (e.g., chemical extraction for fat, histology/biopsy for iron/fibrosis, though biopsy has limitations) or well-validated reference standards (phantoms or highly accurate established MRI methods). The document mentions "purpose-built phantoms containing vials with different relaxation times corresponding to the physiological ranges of tissue values" were used for accuracy and precision, implying these phantoms served as a form of ground truth for those measurements.

4. Adjudication method for the test set

The document does not describe any expert adjudication methods (e.g., 2+1, 3+1) for the test set within this summary. For this type of quantitative imaging device, the focus is more on technical accuracy and precision against established physical or biological references rather than subjective expert consensus on image interpretation.

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

The document does not report an MRMC comparative effectiveness study where human readers' performance with and without AI assistance (LMSv5) was evaluated. The device is described as "post-processing software" that provides "additional diagnostic input" and is "an aid to diagnosis." It includes "automatic processing functionality based on machine-learning to assist in the quantification of metrics... such as automatic artefact detection and automatic segmentation of the liver." However, the study described focuses on the device's standalone performance (accuracy, precision, variability) and not on its impact on human reader performance in a controlled comparative setting.

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

Yes, a standalone performance assessment was done. The testing described focuses on the device's intrinsic capabilities:

• "The accuracy and precision of device measurements was assessed using purpose-built phantoms..."
• "To assess the precision of LiverMultiScan v5 measurements across supported scanners, in-vivo volunteer data was used."
• "Inter and intra operator variability was also assessed." (While this involves human operators, it assesses the device's consistency under different human interactions, not the human's diagnostic performance).
• The device is a "standalone software device" and "All operations are directly controlled by the LiverMultiScan device."

This indicates that the technical performance of the algorithm itself, in generating the quantitative metrics (PDFF, T2*, LIC, cT1), was evaluated.

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

The primary ground truth described in this summary are:

• Physical Phantoms: "purpose-built phantoms containing vials with different relaxation times corresponding to the physiological ranges of tissue values expected to be seen in-vivo" were used to assess the accuracy and precision of measurements. This provides a quantifiable, objective ground truth for the relaxation times and component fractions (like fat).
• For LIC, the device "uses the measured T2* value and uses them to characterise iron loading in the liver which is then transformed by a defined calibration curve to provide a quantitative measure of liver iron concentration in vivo." This implies the ground truth for establishing that calibration curve would likely have been against biopsy-derived liver iron concentration data or other highly validated reference methods in earlier studies (though not explicitly stated for this particular submission's testing itself, it's the basis for LIC quantification).

8. The sample size for the training set

The document does not specify the sample size used for the training set. It mentions that LMSv5 includes "automatic processing functionality based on machine-learning to assist in the quantification of metrics during analysis, such as automatic artefact detection and automatic segmentation of the liver." This clearly indicates machine learning was used, and thus a training set was necessary. However, the size and characteristics of that training set are not included in this 510(k) summary.

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

The document does not detail how the ground truth for the training set (used for machine learning components like automated segmentation and artifact detection) was established. Typically, for such features, ground truth would be established through:

• Expert manual segmentation/annotation: Radiologists or trained medical image analysts would manually delineate liver boundaries and artifacts on a large dataset of MR images.
• Consensus from multiple experts: To reduce individual bias, several experts might review and agree upon segmentations or artifact labeling.

However, these specifics are omitted from this summary.

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LiverMultiScan (LMSv4) 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 (LMSv4) 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 (LMSv4) 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 assessments of selected regions include the determination of triglyceride fat fraction in the liver (PDFF), T2* and iron-corrected T1 (cT1) measurements. T2* may be optionally computed using the DIXON or LMS MOST methods.

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

LiverMultiScan is a standalone software device. The purpose of the LiverMultiScan device is to assist a trained operator with the evaluation of information from Magnetic Resonance (MR) images from a single time-point (a patient visit). LiverMultiScan is a post-processing software device, a trained operator uses tools such as automatic liver segmentation and region of interest placement upon previously acquired MR images, from which a summary report is generated. The summary report is subsequently sent to an interpreting clinician at the acquiring site.

LiverMultiScan is not intended to replace the established procedures for the assessment of a patient's liver health by an interpreting clinician, providing many opportunities for competent human intervention in the interpretation of images and information displayed.

The metrics are intended to be used as an additional diagnostic input to provide information to clinicians as part of a wider diagnostic process. It is expected that in the normal course of liver disease diagnosis, patients with clinical symptoms or risk factors which may indicate liver disease. The interpreting clinician needs to take into consideration the device's limitations and accuracy during clinical interpretation.

Liver function tests, blood tests, ultrasound scanning as well as liver biopsy are all expected to be used at the discretion of a qualified clinician in addition to information obtained from the use of LiverMultiScan metrics. The purpose of LiverMultiScan metrics is to provide imaging information to assist in characterizing tissue in the liver, in addition to existing methods for obtaining information relating to the liver. LiverMultiScan metrics are not intended to replace any existing diagnostic source of information but can be used to identify patients who may benefit most from further evaluation, including biopsy.

Information gathered through existing diagnostic tests and clinical evaluation of the patient, as well as information obtained from LiverMultiScan metrics, may contribute to a diagnostic decision.

LiverMultiScan is not a computer-aided diagnostic device and can only present imaging information which must be interpreted by a qualified clinician. LiverMultiScan is an aid to diagnosis and treatment decisions remains the responsibility of the clinician.

In consequence, the product is considered to have no adverse effect on health since the results represent only a part of the information that the user will utilize for final interpretation. In this regard, LiverMultiScan presents a moderate level of concern with respect to patient safety.

Here's a detailed breakdown 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 acceptance criteria are implicitly defined by the performance test results demonstrating acceptable levels of accuracy, repeatability, and reproducibility. The document states that the observed variations were "well within the prescribed acceptance criteria," but the numerical values for the criteria themselves are not explicitly listed. Instead, the reported performance values are provided.

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size for the test set. For the bench testing, it mentions "purpose-built phantoms" and for clinical testing, "in-vivo acquired volunteer data." The number of phantoms or volunteers is not specified.
• Data Provenance:
  • Bench Testing: Data was acquired from "purpose-built phantoms." The country of origin is not specified, but the applicant (Perspectum Ltd) is based in the UK.
  • Clinical Testing: "in-vivo acquired volunteer data" from "volunteers participating in the performance testing were representative of the intended patient population." The country of origin for these volunteers is not specified. The study appears to be prospective for the gathered "volunteer data" in the sense that data was acquired for the purpose of testing, but the details are sparse.

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

The document does not mention the use of experts to establish ground truth for the test set.

• Bench Testing: Ground truth for phantom accuracy was based on the "gold standard" to which the LMSv4 values were compared. This "gold standard" is implied to be the known physical properties or reference measurements of the phantoms.
• Clinical Testing: The clinical performance relates to repeatability and reproducibility of the device's measurements themselves, not against a human-established ground truth. Operator variability was assessed, implying trained operators were involved, but their qualifications and number are not detailed beyond "trained internal Perspectum operators."

4. Adjudication Method for the Test Set

No adjudication method for the test set is mentioned. The performance testing focuses on the device's intrinsic accuracy, repeatability, and reproducibility, rather than agreement with human interpretation that would typically require adjudication.

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

No MRMC comparative effectiveness study was done. The document states: "No clinical investigations or studies were conducted during performance testing of LMSv4." The device is positioned as an "aid to diagnosis" and "not intended to replace any existing diagnostic source of information," suggesting its role is as a tool rather than a standalone diagnostic.

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

Yes, a standalone performance study was clearly done. The "Performance Testing - Bench" section directly assesses the "accuracy and precision of device measurements" using phantoms. The "Performance Testing - Clinical" section assesses the "precision of LMSv4 measurements" (repeatability and reproducibility) using volunteer data. While operator variability was assessed, the core measures are of the algorithm's output. The device itself is described as a "post-processing software device" where an "operator uses tools such as automatic liver segmentation and region of interest placement," implying the algorithm performs the quantification and the operator interfaces with it.

7. Type of Ground Truth Used

• Bench Testing: The ground truth for accuracy was established using a "gold standard" derived from the "purpose-built phantoms" that contained vials with known relaxation times.
• Clinical Testing: For repeatability and reproducibility, the "ground truth" is essentially the device's own consistent measurement across repeated scans, different scanners/field strengths, and different operators. It is not externally validated against pathology or clinical outcomes in this document.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set. It focuses solely on the performance testing of the device.

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

The document does not provide any information regarding the training set or how its ground truth was established, as it does not describe the development or training of the LMSv4 algorithm. The emphasis is on proving substantial equivalence to a predicate device through performance benchmarking.

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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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LiverMultiScan (LMSv2) 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 (LMSv2) 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 (LMSv2) provides a number of quantification tools, such as Region of Interest (ROI) placements, to be used for the assessment of regions of an image to quantify liver tissue characteristics, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.

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

LiverMultiScan (LMSv2) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from compatible MR Scanners. LiverMultiScan runs on a general purpose workstation with a colour monitor, keyboard and mouse.

LiverMultiScan (LMSv2) is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the operator may also create, display, print, store and distribute reports resulting from interpretation of the datasets.

LiverMultiScan (LMSv2) allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver, T2* and iron-corrected T1 measurements.

LiverMultiScan (LMSv2) provides a number of tools, such as circular region of interest placements, to be used for the assessment of regions of an image to support a clinical workflow.

LiverMultiScan (LMSv2) allows the operator to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat.

LiverMultiScan (LMSv2) is intended to be used by trained operators. Reports generated by trained operators are intended for use by interpreting clinicians, including, but not limited to radiologists, gastroenterologists, and hepatologists.

LiverMultiScan (LMSv2) is an aid to diagnosis. When interpreted by a trained clinician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows.

LiverMultiScan (LMSv2) offers the following.

• Advanced visualisation of MR data.
• Processing of MR data to quantify tissue characteristics including MR relaxivity constants such as T2*, T1, ironcorrected T1 (cT1) and triglyceride fat fraction (expressed as liver fat percentage).
• Circular region of interest statistics.
• Snapshot of images to include in a report.
• Report to include region statistics, snapshot images and user-entered text.
• Export of snapshot images to report.

Here's a summary of the acceptance criteria and study details for LiverMultiScan (LMSv2) based on the provided FDA 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are framed in terms of accuracy, repeatability, reproducibility, and equivalence to the predicate device (LMSv1) for the measurements of T1 (corrected T1 or cT1 for in vivo), T2*, and Proton Density Fat Fraction (PDFF, also referred to as triglyceride fat fraction).

Phantom Study Performance:

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LMS is indicated for use as magnetic resonance diagnostic device software application for non-invasive liver evaluation that enables the generation, display and review of 2D magnetic resonance medical image data and pixel maps for MR relaxation times.

LMS is designed to utilize DICOM 3.0 compliant magnetic resonance image datasets, acquired from Siemens MAGNETOM Skyra MR Scanners, to display the internal structure of the abdomen including the liver. Other physical parameters derived from the images may also be produced.

LMS provides a number of quantification tools such as rulers and region of interest to be used for the assessment of regions of an image to support existing clinical workflows.

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

LiverMultiScan (LMS) is a standalone software application for displaying 2D Magnetic Resonance medical image data acquired from Siemens MAGNETOM Skyra MR Scanners. LMS runs on a workstation with color monitor, keyboard and mouse.

LMS is designed to allow the review of DICOM 3.0 compliant datasets stored on the workstation and the user may also create, display, print, store and distribute reports resulting from interpretation of the datasets.

LMS allows the display and comparison of combinations of magnetic resonance images and provides a number of tools for the quantification of magnetic resonance images, including the determination of triglyceride fat fraction in the liver.

LMS provides a number of tools such as rulers and circular region of interest to be used for the assessment of regions of an image to support a clinical workflow.

LMS allows users to create relaxometry parameter maps of the abdomen which can be used by clinicians to help determine different tissue characteristics to support a clinical workflow. Examples of such workflows include, but are not limited to, the evaluation of the presence or absence of liver fat.

LiverMultiScan (LMS) is intended to be used by trained healthcare professionals including, but not limited to, radiologists, gastroenterologists, radiographers and physicists.

LiverMultiScan is an aid to diagnosis. When interpreted by a trained physician, the results provide information, which may be used as an input into existing clinical procedures and diagnostic workflows.

LiverMultiScan offers:

• . Advanced visualization of MR data
• . Processing of MR data to quantify tissue characteristics including MR Relaxivity constants such as T2*, T1. cT1 and liver fat percentage
• . Circular Region of interest statistics
• Snapshot of images to include in a report
• Report to include region statistics, snapshot images and user-entered text
• Export of snapshot images and report to storage
• . Integration with Mirada DBx – a software module that maintains a local temporary cache of DICOM data and can interact with PACS, from which it can receive data

Mirada DBx is a medical device data system (MDDS, product code OUG, regulation number 880.6310) used for DICOM connectivity with other systems.

• Ability to send data from Mirada DBx to PACS or other DICOM nodes for archive and distribution

The provided documents (FDA 510(k) summary and letters for LiverMultiScan) describe the device and its intended use, and generally state that it has been validated and verified. They assert that LiverMultiScan is substantially equivalent to the predicate device, Siemens syngo MR E11A software, for both safety and effectiveness.

However, the provided text does not include specific acceptance criteria, detailed study results, or quantitative performance metrics that would allow for a comprehensive breakdown as requested. The document focuses on regulatory compliance and comparison to a predicate device, rather than providing the granular technical study details.

Here's a breakdown of what can be extracted and what is missing:

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

• Missing. The document generally states that "performance, functional and algorithmic testing demonstrate that LiverMultiScan meets the user needs and requirements of the device," and "performs at least as safely and effectively as the listed predicate device." However, no specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity, or error rates) or reported device performance values are provided.

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

• Missing. The documents mention "validated with volunteer and phantom scans" for performance but do not specify the sample size for any test set or the provenance (country of origin, retrospective/prospective nature) of the data.

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

• Missing. The documents mention that images and parameters should be "interpreted by a trained physician" but do not specify the number or qualifications of experts used to establish ground truth for testing.

4. Adjudication method for the test set

• Missing. No adjudication method (e.g., 2+1, 3+1, none) for a test set is described.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size

• Missing. The document does not describe a multi-reader, multi-case comparative effectiveness study, nor does it quantify any effect size of AI assistance on human readers. The comparison is primarily at the device level, concluding substantial equivalence based on intended use and technical characteristics.

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

• Implied, but details are missing. LiverMultiScan is described as a "standalone software application." The validation mentions "algorithmic testing," suggesting standalone performance testing, but no specific results or study design for this are provided. The "intended use" explicitly states that the results, "when interpreted by a trained physician, yield information that may assist in diagnosis," indicating that the device is intended to be used with human-in-the-loop.

7. The type of ground truth used

• Partially available, but vague. The document mentions "validated with volunteer and phantom scans." This implies that physical phantoms with known properties were used for part of the validation, and "volunteer" scans suggest potentially healthy subjects or subjects with characterized conditions. However, the exact nature of the "ground truth" (e.g., expert consensus, pathology, outcome data) for the volunteer scans or for clinical validation is not specified.

8. The sample size for the training set

• Missing. The documents do not provide any information about the training set size, or even explicitly state that a machine learning model requiring a training set is part of the device (though "algorithmic testing" might imply this).

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

• Missing. As the training set size and existence are not described, the method for establishing its ground truth is also not mentioned.

Summary of what is available from the document:

• Device Name: LiverMultiScan (LMS)
• Intended Use: Non-invasive liver evaluation by generating, displaying, and reviewing 2D MR medical image data and pixel maps for MR relaxation times from Siemens MAGNETOM Skyra MR Scanners. Provides quantification tools (rulers, ROI) and physical parameters (like triglyceride fat fraction, T1, cT1, T2* mapping) for interpretation by a trained physician to assist in diagnosis.
• Regulatory Class: Class II (892.1000) Product Code: LNH
• Predicate Device: Software syngo MR E11A for the MAGNETOM systems Aera/Skyra (Siemens AG, 510(k) K141977)
• Basis for Equivalence: Substantial equivalence based on similar intended use, technological characteristics (e.g., utilizing DICOM 3.0 compliant MR datasets, supporting multi-slice MR data, providing quantification tools like ROI measurements, generating reports), and performance validated with volunteer and phantom scans.
• Standards Met: IEC 62304, DICOM 3.0
• Compatibility: Compatible with data from Siemens Skyra 3T MR scanners and Microsoft Windows.
• Validation Statement: "LiverMultiScan is validated and verified against its user needs and intended use by the successful execution of planned performance, functional and algorithmic testing included in this submission."

The provided document serves as a regulatory submission focused on demonstrating substantial equivalence rather than a detailed technical study report. Therefore, it lacks the specific quantitative data points typically found in clinical validation studies.

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