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

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

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

The subject device, MAGNETOM Avanto® with software syngo MR E11E. is a modification of the previously cleared predicate device, MAGNETOM Avanto" with software syngo MR E11C-AP04 (K173592). The software version syngo E11E for MAGNETOM Avanto™ has been modified to include the software application "Compressed Sensing (CS) Cardiac Cine." This software application was migrated unchanged from the previously cleared MAGNETOM Skyra and Aera systems with syngo MR E11C-AP02 (K163312).

The provided document is a 510(k) summary for the Siemens MAGNETOM Avanto® with software syngo MR E11E. It details the device's substantial equivalence to a predicate device, focusing on a new software feature. However, this document does not contain the specific information required to answer your detailed questions about acceptance criteria and a study proving the device meets those criteria.

The 510(k) summary states:

• No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device (page 7).
• Nonclinical performance testing was conducted, including software verification and validation, and performance testing in accordance with FDA guidance documents (page 6). However, it does not provide details of acceptance criteria for these tests or specific results in numerical form that can be presented in a table against a predefined "acceptance criteria."
• The document implies that the "new" feature (Compressed Sensing (CS) Cardiac Cine) was migrated unchanged from a previously cleared device (MAGNETOM Skyra and Aera systems with syngo MR E11C-AP02 (K163312)). This suggests that the performance and safety of this feature were established in the clearance of the reference device, not necessarily re-tested as a new standalone study for this specific 510(k).

Therefore, based solely on the provided text, I cannot extract the following information:

1. A table of acceptance criteria and the reported device performance: This document reports that testing was done and standards were conformed to, but not the specific metrics, thresholds, or measured values.
2. Sample size used for the test set and the data provenance: Clinical test data with sample sizes are not present, and for nonclinical tests, specific "test sets" in the sense of patient data are not detailed.
3. Number of experts used to establish the ground truth and their qualifications: As no clinical study is reported, this information is not applicable to the data provided.
4. Adjudication method for the test set: Not applicable without a clinical study.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: The document explicitly states "No clinical tests were conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: While "performance testing" was mentioned for nonclinical data, the specifics of an algorithm-only standalone study with human-level metrics are not provided.
7. The type of ground truth used: Not specified, as clinical data and ground truth establishment methods are not detailed.
8. The sample size for the training set: This is a 510(k) for a hardware/software system, not an AI/ML device that typically has a "training set" in the context of deep learning. The new feature is a "Compressed Sensing (CS) Cardiac Cine" software application, which is a signal processing technique, not necessarily a machine learning algorithm that requires a "training set" in the conventional AI sense.
9. How the ground truth for the training set was established: Not applicable for the reasons mentioned above.

Conclusion based on the provided document:

The 510(k) summary focuses on demonstrating substantial equivalence through:

• Confirmation that the device's indications for use are the same as the predicate device.
• Confirmation that the new software feature ("Compressed Sensing (CS) Cardiac Cine") was migrated unchanged from an already cleared reference device (K163312).
• Compliance with recognized standards (IEC, ISO, NEMA) for safety and software development.
• Software verification and validation testing, and general device performance testing, all non-clinical.

The document does not contain the details of a study with specific acceptance criteria, reported performance metrics, or clinical ground truth establishment as requested in your prompt. This type of detailed performance data is typically found in accompanying test protocols and reports, which are part of the larger 510(k) submission but not always fully summarized in the publicly available 510(k) summary.

Ask a specific question about this device

Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These inages and/ or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

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

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

Hardware
New Hardware

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

Modified Hardware

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

Software
New Features and Applications

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

Modified Features and Applications

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

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

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

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

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

• MR Elastography:

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

• Optimization of pulse sequence type timing. |

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

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

Modified (general) Software / Platform

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

Other Modifications and / or Minor Changes

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

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

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

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

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

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

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

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

• Siemens "BioMatrix" (extension with additional components)

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

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

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

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

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

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

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

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

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

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

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

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

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

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

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

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

8. The sample size for the training set:

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

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

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

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

Ask a specific question about this device

Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These inages and/ or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

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

MAGNETOM Sola with software syngo MR XA11A is similar to the previous cleared predicate device MAGNETOM Aera with syngo MR E11C (K153343) but includes new and modified hardware and software compared to MAGNETOM Aera. A high level summary of the hardware and software changes is included below.

The provided text describes the Siemens MAGNETOM Sola, a Magnetic Resonance Diagnostic Device (MRDD), and its journey through FDA clearance via a 510(k) premarket notification (K181322). The submission argues for substantial equivalence to a predicate device, MAGNETOM Aera (K153343). However, the document does not include a table of acceptance criteria or report device performance against specific metrics as requested. It outlines the scope of changes, safety testing, and refers to clinical images and a specific clinical study for nerve stimulation thresholds, but it doesn't detail performance-based acceptance criteria for image quality or diagnostic accuracy in the way typically seen for AI/ML devices.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

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

The document does not provide a table of acceptance criteria or specific reported device performance metrics against such criteria in the context of diagnostic accuracy or image quality improvements. The submission focuses on demonstrating substantial equivalence through:

• Similar intended use to the predicate device.
• Conformity to relevant standards (IEC, ISO, NEMA).
• Software verification and validation.
• Sample clinical images to support new/modified features.
• A clinical study to determine nerve stimulation thresholds for gradient system output.

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

• Sample size for test set:
  • For the nerve stimulation thresholds study: 36 individuals.
  • For testing new/modified pulse sequences and algorithms, and supporting new coils/features: "Sample clinical images" were taken, but the exact number of cases or individuals is not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "Sample clinical images were taken" and "A clinical study... was conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not specify the number or qualifications of experts used to establish ground truth for image quality assessments or the clinical images provided. The nerve stimulation study likely involved medical professionals, but their role in "ground truth" establishment for diagnostic purposes is not detailed.

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

The document does not describe any adjudication method for the test set.

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 multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The device is a Magnetic Resonance Diagnostic Device, not explicitly an AI/ML-driven diagnostic aid that would directly assist human readers in interpretation or diagnosis in the context typically seen in MRMC studies for AI.

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

The document describes the MAGNETOM Sola as a "magnetic resonance diagnostic device" which produces images and/or spectra that, "when interpreted by a trained physician, yield information that may assist in diagnosis." This indicates a human-in-the-loop system, implying that a standalone "algorithm only" performance study for direct diagnostic output was not the primary focus or perhaps applicable in the traditional sense for this device submission which is for the MR system itself rather than an AI-driven interpretation tool. However, the software verification and validation are for the algorithm within the system.

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

The type of ground truth used for image quality assessments or for the "sample clinical images" is not explicitly stated. For the nerve stimulation study, the "observed parameters were used to set the PNS (Peripheral Nerve Stimulation) threshold level," which seems to be a physiological measurement rather than a diagnostic ground truth.

8. The sample size for the training set

The document does not mention a training set sample size. This type of information is typically provided for AI/ML models that undergo specific training, which isn't the primary focus of this MRDD system clearance description.

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

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

Ask a specific question about this device

The MAGNETOM systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.

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

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

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

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

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

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

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

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

It discusses:

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

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

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Your MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body, or extremittes. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

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

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

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

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

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

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

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

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

8. The sample size for the training set

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

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

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

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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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