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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/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 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 displays and MR Safe biopsy needles.

MAGNETOM Skyra Fit with software syngo MR XA50A includes new and modified hardware and software compared to the predicate device, MAGNETOM Vida with software syngo MR XA31A. A high level summary of the new and modified hardware and software is provided below:

Hardware
Modified Hardware

• Cover: The cover has been modified to bring the system up to the Siemens Healthineers Design incl. all BioMatrix components and interfaces.
• EPC (Electronic Cabinet and Measurement Control / Electronic Power Cabinet): upgrade of components to upgrade the EPC to the newest electronic cabinet series

Software
New Features and Applications

• TSE MoCo: TSE MoCo is an image-based motion correction in the averagedimension for the TSE pulse sequence type.
• Automatic fiducial detection: MR Breast Biopsy is improved with an automatic fiducial detection.

Modified Features and Applications

• Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
  Other Modifications and / or Minor Changes
• The MAGNETOM Skyra Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Verio.

The provided document is a 510(k) summary for the MAGNETOM Skyra Fit device, which is a Magnetic Resonance Diagnostic Device (MRDD). This document primarily focuses on establishing substantial equivalence to a predicate device (MAGNETOM Vida) and does not detail a clinical study with acceptance criteria, human reader performance, or training/test set specifics for an AI algorithm.

The document states:

• "No additional clinical tests were conducted to support substantial equivalence for the subject device; however, as stated above, sample clinical images were provided. No clinical publications were referenced." (Page 6, Section 10. Clinical Tests / Publications)
• The performance tests conducted were "Sample clinical images" and "Image quality assessments by sample clinical images." (Page 6, Section 9. Nonclinical Tests)

Therefore, based on the provided text, a detailed answer to your request, particularly concerning acceptance criteria for an AI device, human reader studies, and AI training/test set specifics, cannot be fully provided directly from this document. This document describes a new MR system, not an AI software.

However, I can extract the information that is present and explain where the requested information is not available:

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

   • Not explicitly provided in terms of numerical acceptance criteria for a clinical study comparing performance against a predicate. The document states: "The results from each set of tests demonstrate that the subject device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared." (Page 6, Section 9. Nonclinical Tests). The performance assessment appears to be qualitative based on "sample clinical images" and "image quality assessments."
   • Device Performance (as described): "The subject device performs as intended and is thus substantially equivalent to the predicate device." (Page 6)

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

   • Not provided. The document mentions "sample clinical images" but does not specify the sample size, data provenance, or whether they were retrospective or prospective.

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)

   • Not provided. The document refers to images interpreted by a "trained physician" for diagnosis (Page 5, Section 5. Intended Use), but this is a general statement about the use of an MRDD, not specific to establishing ground truth for a test set in the context of a new feature evaluation or AI study.

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

   • Not provided.

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

   • No MRMC study was done. The document explicitly states, "No additional clinical tests were conducted to support substantial equivalence for the subject device..." (Page 6).

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

   • Not applicable/Not done for an AI algorithm. This document is for an MR imaging system, not an AI diagnostic algorithm.

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

   • Not explicitly stated/not applicable in the context of an AI study. The "sample clinical images" were likely evaluated for image quality and equivalence to the predicate, rather than for diagnostic ground truth for an AI algorithm.

8. The sample size for the training set

   • Not applicable/Not provided. This is not a submission for an AI algorithm that would require a distinct training set.

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

   • Not applicable/Not provided.

Summary based on the provided document:

This 510(k) submission for the MAGNETOM Skyra Fit MRI system focuses on demonstrating substantial equivalence to a previously cleared predicate device (MAGNETOM Vida) by showing that new and modified hardware and software features maintain equivalent safety and performance. This is typically achieved through non-clinical performance testing, including image quality assessments, software verification and validation, and electrical/mechanical safety tests, rather than multi-reader clinical studies or AI algorithm performance evaluations.

The "sample clinical images" mentioned are likely used to qualitatively demonstrate that the new system's output images are comparable in quality to those of the predicate device, thereby supporting the claim of substantial equivalence for diagnosis when interpreted by a trained physician. The document explicitly states that no additional clinical tests were conducted, meaning there were no new studies involving human readers or comparative effectiveness with or without AI assistance.

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The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined sys tem maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

The MR is intended to produce transverse, sagittal, coronal and obligue crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their label ing. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR safe biopsy needles.

The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

The subject device, syngo MR E11P-AP01 system software for the Biograph mMR system, is a modification of the previously cleared predicate device Biograph mMR with syngo MR E11P system software (K163234, cleared February 28, 2017). The subject device has been modified to include the new mMR 32 Head coil for combined MR-PET usage as well as improvements to the system software syngo MR E11P.

• Improvement of the SPACE pulse sequence type with:
• CAIPIRINHA acquisition technique named as CAIPIRINHA o SPACE (migrated from previously cleared reference device K173592)
• Additional magnetization preparation mode "Non-sel. T2 prep. IR" o for brain imaging with improved dark-fluid contrast.
• Implementation of "CP-only" RF transmission mode based on the । requirements of 60601-2-33 Ed. 3.2:2015.

I am unable to conduct a detailed analysis of the acceptance criteria and study as the provided text is a 510(k) summary for a medical device (Biograph mMR with syngo MR E11P-AP01 system software) and does not contain the specific information required to complete your request.

Here's why and what's missing:

• No Explicit Acceptance Criteria: The document describes modifications to an existing device (software updates, new head coil). It states that nonclinical data "suggests that the feature bear an equivalent safety and performance profile as that of the predicate device." However, it does not define specific quantitative acceptance criteria for performance metrics (e.g., specific thresholds for image quality, signal-to-noise ratio, diagnostic accuracy, etc.) that the device must meet.
• No Detailed Study Results: While it mentions "nonclinical tests" were conducted and "clinical images are provided to support the migrated coil as well as the improved software features," it does not provide the results of these tests. It only makes a general statement that the device "performs as intended."
• Lack of Specifics for Your Questions: The text is a regulatory submission demonstrating substantial equivalence, not a detailed scientific study report. Therefore, it does not include:
  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets, data provenance, or details about patient cohorts (e.g., country of origin, retrospective/prospective nature).
  • Number or qualifications of experts for ground truth establishment.
  • Adjudication methods.
  • Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
  • Details of standalone algorithm performance.
  • Specific types of ground truth used (beyond general "clinical images").
  • Sample size or ground truth establishment methods for training sets.

In essence, the document confirms that testing was done to ensure the modified device is substantially equivalent to its predicate, but it does not delve into the granular details of those tests, their results, or the precise acceptance criteria used, which would be found in a more comprehensive study report or internal validation documentation.

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

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

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

Hardware: Computer, Coils (BM Body 18)

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

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

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

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

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

4. Adjudication Method for the Test Set:

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

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

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

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

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

7. Type of Ground Truth Used:

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

8. Sample Size for the Training Set:

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

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

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

Summary of the Study:

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

The non-clinical tests included:

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

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

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The MAGNETOM Terra system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the head or extremities. Other physical parameters derived from the images may also be produced.

Additionally the MAGNETOM Terra is intended to produce Sodium images for the head and Phosphorus spectroscopic images and/or spectra for whole body, excluding the head.

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

The device is intended for patients > 30 kg/66 lbs.

MAGNETOM Terra is a 60 cm bore Magnetic Resonance Imaging system with an actively shielded 7T superconducting magnet. With the interplay of the magnetic field, gradients, radio frequency (RF) transmitter and receiver coil and software this magnetic resonance scanner produces transverse, sagittal, coronal and oblique cross sectional images that represent the spatial distribution of protons with spin.

Additionally the MAGNETOM Terra produce Sodium images for the head and Phosphorus spectroscopic images and/or spectra for the whole body, excluding the head.

For MAGNETOM Terra four local transmit/receive coils for the specific applications are available, these are:

1Tx32Rx Head Coil 7T Clinic; 1Tx28Rx Knee Coil 7T Clinic;

31P/1H TxRx Flex Loop 7T; 23Na 1Tx32Rx Head 7T

This document is a 510(k) summary for the Siemens MAGNETOM Terra medical device, a Magnetic Resonance (MR) system. It describes modifications to an existing device (MAGNETOM Terra with syngo MR E11K) to add new capabilities: Sodium (23Na) imaging of the head and Phosphorus (31P) spectroscopic imaging/spectra for the whole body, excluding the head.

The document does not contain acceptance criteria in the form of quantitative performance metrics for device output, nor does it describe a comparative study that proves the device meets specific acceptance criteria. Instead, the submission argues for substantial equivalence to a predicate device and reference devices based on non-clinical testing, software validation, and existing clinical literature.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing/not applicable for this type of submission:

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

• Missing. This submission does not provide a table of acceptance criteria with corresponding performance results. The focus is on demonstrating that the new functionalities (23Na imaging and 31P spectroscopy) are safe and effective, and do not raise new questions of safety or effectiveness compared to predicate and reference devices. The "performance" mentioned refers broadly to the device performing as intended through non-clinical tests (image quality assessments, surface heating, software V&V).

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

• Test Set (Non-clinical Data):
  • "Sample clinical images or Phosphorus spectra were acquired for all modified / new pulse sequences and local coils."
  • "reports from one U.S. board-certified radiologist have been provided. The radiologist reviewed Sodium head images of healthy volunteers and patient with respect to their diagnostic quality."
  • Sample Size: Not explicitly stated as a numerical count for healthy volunteers or patients beyond "sample clinical images" and "patient." Only "one U.S. board-certified radiologist" is mentioned as reviewing the images.
  • Data Provenance: Implied to be prospective, collected for the purpose of this submission (e.g., healthy volunteers suggests prospective collection). The location is "U.S." for the radiologist, but not explicitly stated for where the images were acquired, though likely in Europe where manufacturing site is, or US where Siemens Medical Solutions USA is.
• Training Set:
  • Not Applicable. This submission is for modifications to an existing MR system and relies on demonstrating substantial equivalence, not the development and validation of an AI/ML algorithm that would typically require a training set. The new functionalities are extensions to existing MR capabilities, not an AI output.

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

• Number of Experts: One. "reports from one U.S. board-certified radiologist have been provided."
• Qualifications: "U.S. board-certified radiologist." No specific experience (e.g., "10 years of experience") is mentioned.

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

• None stated. Only one radiologist reviewed the images. There is no mention of a consensus or adjudication process given only one reader.

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

• No. An MRMC study was not conducted. This is not an AI-assisted device, but rather an MR imaging system with extended capabilities. The submission focuses on the safety and effectiveness of the device itself for acquiring images/spectra, not how it impacts human interpretation via assistance.

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

• Not Applicable. This is an MR acquisition device, not a standalone diagnostic algorithm. Its output (images and spectra) is intended to be interpreted by a trained physician. No such "algorithm only" performance would be relevant here.

7. The type of ground truth used:

• For the non-clinical images reviewed by the radiologist: The "ground truth" seems to be effectively the expert opinion/qualitative assessment of the single U.S. board-certified radiologist regarding diagnostic quality, artifacts, and concerns. There's no mention of pathology, clinical outcomes, or a multi-expert consensus serving as a formal ground truth.

8. The sample size for the training set:

• Not Applicable. As noted above, this is not an AI/ML device that requires a training set.

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

• Not Applicable. No training set was used.

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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 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.

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