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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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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 system 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 oblique 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 labeling. This system may also be used for imaging during interventional procedures wen 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 correction maps for PET studies. The system provides inherent anatomical reference for the fissed PET and MR images due to precisely aligned MR and PET image coordinate systems.

The new mMR Angio Transfer Option is being introduced for the Biograph mMR system.

The new option is intended to provide a patient transfer from the SIEMENS Artis Q and Artis Q.zen (K123529) or Artis zee/zeego SW VC21 (K141574) System to the Biograph mMR and vice versa.

To achieve this functionality a Transferboard Artis (further named as Transferboard) will be used where the patient is located and transferred. This Transferboard can be adapted on the standard table of the Artis Q and Artis Q.zen (K123529) or Artis zee/zeego SW VC21 (K141574) System. The standard table is identical for all models. By swiveling the Artis Q. Artis Q.zen or Artis zee /zeego table (standard function) the Transferboard will be positioned in front of the Biograph mMR. Via the Guiding Slide Way the Transferboard is pushed manually on the Table Top of the Biograph mMR.

The Guiding Slide Way is also included in the option and is installed on the Table Top of the Biograph mMR instead of a regular patient cushion.

The Transferboard is also used to move the patient into the bore of the Biograph mMR for further diagnostic imaging.

The basic device and its functionality remain unchanged except for the following modifications:

• . Coil Adapter Cover (CAC): The Coil Adapter Cover will replace the standard mMR coil adapter cover on the foot end of the mMR tabletop to enable the overtraveling of the Transferboard (TFB).
• Guiding Slide Wav (GSW): A Guiding Slide Way (GSW) will be adapted on the ● existing Biograph mMR tabletop. This is a foldable option and can be removed for diagnostic mMR examination in case the transfer option is not needed.
• Transferboard (TFB): The Transferboard (TFB) is intended to transfer the ● patient. The patient remains on this board during the whole intraoperative procedure.
• Patient Cushion (LGH): The Patient Cushion is laid on the Transferboard (TFB) for comfortable reclining.
• Fixation Belts: The Fixation Belts are used for preventing the patient to fall of ● the Transferboard and Patient Cushion during transport, surgery and imaging,
• Transfer Support Cart (TSC): The Transfer Support Cart is part of the option. ● It ensures that both tables have the same height and that there are no vibrations during transfer due to load changes on the patient tables

The new mMR Angio Transfer Option for the Biograph mMR system requires the most recent Device Software, syngo MR E11P software cleared via 510(k) on February 28, 2017 (K163234).

This document describes a 510(k) premarket notification for the "Biograph mMR with mMR Angio Transfer Option." This submission primarily addresses changes related to a patient transfer system, not a software algorithm for disease detection or diagnosis. Therefore, much of the information typically requested for AI/ML device studies (such as diagnostic performance metrics, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies) is not applicable or present in this document.

The acceptance criteria and "study" mentioned here relate to the safety and performance of the mechanical and electrical modifications that enable patient transfer between imaging systems.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. This submission doesn't involve a test set of medical images or patient data for diagnostic performance evaluation. The "testing" refers to non-clinical performance evaluations of the mechanical and electrical components of the transfer option.
• Data Provenance: Not applicable. The "data" comes from engineering tests and evaluations of the new mechanical components and their integration with the existing Biograph mMR system, rather than patient data.

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

• Not applicable. There is no diagnostic "ground truth" or expert review of image data described, as this is not a diagnostic AI/ML device submission. The verification and validation were engineering-focused.

4. Adjudication method for the test set

• Not applicable for the reasons stated above.

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 comparative effectiveness study was not done. This device is an imaging system enhancement for patient transfer, not an AI diagnostic tool.

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

• Not applicable. This device is not an algorithm for standalone performance evaluation.

7. The type of ground truth used

• Not applicable. The "ground truth" for the non-clinical performance testing would be the engineering specifications and safety requirements defined by the referenced standards (e.g., proper mechanical function, electrical safety thresholds, risk mitigation effectiveness).

8. The sample size for the training set

• Not applicable. There is no machine learning component or training set involved in this submission.

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

• Not applicable. There is no machine learning component or training set involved in this submission.

In summary: This FDA filing (K172531) is for a modification to an existing medical imaging system (Biograph mMR) that introduces a new patient transfer option. The "study" and "acceptance criteria" discussed are related to the engineering and safety performance of these physical modifications, ensuring they meet recognized medical device standards (e.g., IEC, ISO) and do not negatively impact the safety or effectiveness of the original device. This is a typical submission for mechanical or electrical modifications to existing hardware, not for a new AI/ML diagnostic software as the questions largely imply.

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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 system 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 oblique crossectional MR images, spectroscopic inages 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 labeling. 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 fised PET and MR images due to precisely aligned MR and PET image coordinate systems.

The subject device, syngo MR E11P system software, is being introduced for the Biograph mMR system.

The syngo MR E11P SW includes new sequences, new features and minor modifications of already existing features. A high level summary of the new sequences and features is included below.

Migrated sequences and features from the previously cleared secondary predicate devices MAGNETOM Verio with syngo MR D13A and Siemens E-line Software with MAGNETOM Skyra with syngo MR E11C (K153343) are not described separately as these are commercially available and no changes are introduced for this system.

Improvement in Attenuation Correction
Atlas-based bones in u-map generation
The bone attenuation map is computed based on a reqular 4-compartment (air, lung, fat, water) segmentation from a Dixon sequence. As improvement, the bone information is added to these u-maps with a model-based bone segmentation algorithm using continuous linear attenuation coefficients (LACs) for bone to represent the variation in cortical bone density in different anatomical areas.

The model consists of the most relevant bones in the body torso in terms of overall attenuation. It consists of the skull, spine, pelvis and femur bone as individual components.

MR based FoV extension for attenuation correction - (HUGE)
In this SW version syngo MR E11P the attenuation map can be improved by using an optional MR-based FoV extension technique. This technique requires an additional MR measurement optimized for distortion reduced acquisition of the patient's arms resting along the body at the edge of the FoV.

New and Modified Features
Multimodal (Elastic) Motion Correction (BodyCOMPASS)
Elastic motion correction is introduced to reduce the effect of blur induced by respiratory motion during a PET acquisition. As a basic principle, periodic motion information is collected by means of the MR as a 4D image series and used for PET to

• . bin the PET counts into separate respiratory states
• provide a mapping for each spatial position and each respiratory state to a . reference state, which can be used in the PET reconstruction

Hence, the resulting PET image combines the advantages of a gated PET image with reduced motion blur while preserving the signal-to-noise ratio of static non-gated reconstruction.

Improvement in DIXON fat water separation
In this SW version syngo MR E11P the DIXON reconstruction technique (fat/water separation) is improved. The improved algorithm is based on global optimization and thus minimizes the probability of local fat/water swaps where part of water image is wrongly assigned to fat image and/or vice versa.

Dot Cockpit (DotGO), including PET Workflow
The previously cleared DotGO with the Dot Cockpit and the MR only Dot Engines is now available on the Biograph mMR with syngo MR E11P. The configuration of PET workflows is now integrated into the Dot Cockpit for higher productivity.

This modification increases the robustness and usability for the clinical workflow with the new PET Planning Group. PET Planning Step and special reduced MR Parameter cards while still offering the full parameter access with detail views, PET and AC specific steps with their parameter cards.

Improved MR PET Workflow
With the software syngo MR E11P a set of protocols are included in order to run a clinical whole body workflow with 5 beds, AC, T1-, T2-, DWI-contrast, adjustments and SAR pauses in 45 minutes.

In this workflow the AC protocol is acquired in high resolution (1.3 mm * 1.3mm in plane) using CAIPIRINHA acceleration. Alternatively, an AC protocol in conventional resolution (2.6 mm * 2.6 mm in plane) using CAIPIRINHA acceleration is available in order to reduce the acquisition time for AC measurement in case T1-contrast is not requested from AC scan.

Other Software Improvements
NEMA NU 2:2012
As it is possible that routine NEMA testing may be required to retain ACR accreditation, Siemens has developed an optional software package which enables a Biograph mMR system user to quantify image quality for certain performances according to the most recent available NEMA standards.

Improvements in Retro Recon Task Card
In the RetroRecon Task Card of the Biograph mMR with syngo MR E11P, an additional identifier in the list of the parameter Attenuation Correction indicates gated u-Maps.

Furthermore a Tooltip for the Attenuation Correction parameter explains the identifier.

For respiratory gating a new Respiratory Curve Display shows the recorded cushion signal as well as the specified gates for some gating types.

Third Party Interface for AC
An Interface functionality is added to the synqo MR E11P software to import attenuation maps of third party components for hardware attenuation correction.

Other Modifications
Front Cover Panel Refresh for Biograph mMR
The Biograph mMR with syngo MR E11P will receive new system covers. The graphic design of the cover has been changed to give the systems an updated and more modern look to highlight the introduction of a new software version.

MaRS - technology for Biograph mMR
The modified control system of the Biograph mMR integrates the functions of the AMC (Advanced Measurement Control) and MRIR (MR Image Reconstructor) into one computer called MaRS (Measurement and Reconstruction System).

The MaRS system performs sequence control and image reconstruction without additional MRIR. The introduction of the MaRS was part of the secondary predicate device MAGNETOM Verio with syngo MR D13A (K121434). This is now updated to new computer hardware with this submission.

Physiological Monitoring Unit (PMU)
The Physiological Measurement Unit (PMU) was modified to improve the accuracy of triggers on the respiration signal. The PMU provides ECG, respiration and peripheral pulse as well as external trigger input to control of the MR imaging sequences for synchronization.

Syngo MR Software Features
Other features were included unchanged from the secondary predicate devices (K121434 and K153343). These features expand the Biograph mMR's MR scanning capabilities and update the feature set to be more similar to currently released Siemens MR software.

Acceptance Criteria and Device Performance for Biograph mMR with syngo MR E11P system software (K163234)

Based on the provided FDA 510(k) summary, the acceptance criteria and supporting studies focus on demonstrating that the new syngo MR E11P software for the Biograph mMR system maintains the safety and effectiveness of the predicate device while introducing improvements and new features. The document highlights the substantial equivalence argument, rather than providing explicit numeric acceptance criteria and performance tables for specific clinical tasks. However, we can infer the performance goals and the studies conducted to support them.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit numeric acceptance criteria and a detailed performance table are not provided in the 510(k) summary, the table below represents the implied acceptance criteria (based on the device's intended use and the nature of the modifications) and the general results reported for demonstrating substantial equivalence.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size (e.g., number of patients, cases) for the clinical images used in the comparison studies. It mentions "Sample clinical images were taken for particular new and modified sequences" and "Additionally clinical images were provided to support the substantial equivalence for the new software features of the subject device." The quantitative comparison studies also imply a dataset, but the size is not specified.
• Data Provenance: The provenance of the data (country of origin, retrospective/prospective) is not explicitly detailed. The manufacturer is Siemens Healthcare GmbH based in Erlangen, Germany, and Siemens Medical Solutions USA, Inc. is the establishment in the USA. It is common for such validation studies to involve data from internal research or collaborating institutions, but the document does not specify. The nature of "clinical images" and "quantitative comparison studies" suggests real patient data, likely retrospective or a mix, but this is not confirmed.

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

This information is not provided in the summary. While clinical images and quantitative comparisons were performed, the method of establishing ground truth and the involvement and qualifications of experts for defining "ground truth" are not described. It's likely that in the context of imaging system performance, "ground truth" for image quality and diagnostic accuracy would implicitly rely on expert assessment, but the details are omitted.

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

This information is not provided in the summary. Without details on expert involvement in ground truth establishment, no adjudication method can be inferred.

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 focusing on the improvement of human readers with AI assistance was not explicitly described in this 510(k) summary. The document describes improvements to the imaging system's software components (e.g., attenuation correction, motion correction, fat/water separation) that likely improve image quality and potentially diagnostic accuracy, but it doesn't quantify reader performance improvement with "AI assistance" in the sense of a decision support system. The listed studies are more focused on the technical performance and quantitative accuracy of the imaging system's outputs.

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

Yes, a form of standalone performance assessment was conducted for many of the technical improvements. The "Nonclinical Tests" section details:

• "Image quality assessments of all new/modified sequences and algorithms, were completed."
• The "Clinical Tests" section describes "Quantitative comparison study of attenuation maps of CT-based AC and MR-based AC method..." and "Quantitative comparison study of SUV estimation for MR-based AC methods..." These are direct technical evaluations of the algorithm's output (image quality, quantitative accuracy) independent of a human reader's diagnostic performance.

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

The type of ground truth used varies based on the specific study:

• For attenuation correction and SUV estimation studies: The ground truth appears to be established by comparison to established methods, specifically "reference CT AC." This implies that CT attenuation maps are considered the gold standard for comparison in these contexts.
• For general image quality and new feature performance: The "ground truth" is likely based on visual assessment by experts (implied, though not stated) combined with quantitative metrics relevant to image quality (e.g., minimizing motion blur, reducing fat/water swaps) derived from predefined technical standards or expected outcomes.

8. The sample size for the training set:

This information is not provided in the summary. The document describes modifications and improvements to existing software components and introduces new sequences and features. While these often involve internal development and testing cycles that might use various datasets, specific training set sizes for machine learning components (if any, beyond the "atlas-based bones" model) are not detailed.

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

This information is not provided in the summary. Given the nature of the improvements (e.g., atlas-based bone models, global optimization for Dixon), it's likely that internal reference datasets and expert knowledge were used, but the specifics of their ground truth establishment are not disclosed. For the "atlas-based bones in u-map generation," the "model consists of the most relevant bones in the body torso" which implies a pre-defined anatomical model or a training process that derived this model from a dataset with defined bone attenuation properties. However, details are absent.

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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 system 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 oblique 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 labeling. 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 Biograph mMR systems are combined Maqnetic Resonance Imaging and Positron Emission Tomography scanners. The Biograph mMR systems provide registration and fusion of high-resolution metabolic, physiologic and anatomic information from the two major components of each system (PET and MR) acquired simultaneously and isocentrically.

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 alianed MR and PET image coordinate systems.

Software syngo MR B20P is a new software version for the Siemens Biograph mMR systems that were previously cleared under K103429 (running software version syngo MR B18P).

New scanners will be manufactured with syngo MR B20P; existing scanners can be upgraded to this software version. The new software version includes new software features, coil modifications and other modified hardware for the Biograph mMR systems.

This 510(k) submission (K133226) from Siemens for "Software syngo MR B20P for Biograph mMR" is a special 510(k), indicating modifications to an already cleared device. As such, the focus of the submission is on demonstrating that the new software and hardware features do not introduce new issues of safety or effectiveness and that the device remains substantially equivalent to its predicate.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly provide a table of quantitative acceptance criteria with corresponding performance metrics for the software changes in the way one might expect for a novel AI algorithm. Instead, the acceptance criteria are implicitly defined by standard engineering and regulatory practices for medical device modifications. The reported device performance is demonstrated through various tests designed to ensure the modified coils and software functions as intended and meet established standards.

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

The document does not specify a distinct "test set" in the context of AI performance evaluation. The non-clinical tests involved:

• Testing of coils (SNR, image uniformity, heating, hybrid mode).
• Phantom testing for MNO Spectroscopy.
• Verification and validation of all software features.
• PET performance testing in accordance with NEMA NU:2.

The data provenance for these tests is implicitly from Siemens' internal testing environment and phantoms, as no patient data (retrospective or prospective) is mentioned as being used for the testing of the modified features to demonstrate conformance.

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

Not applicable. This submission does not describe a study involving expert-established ground truth on a test set (e.g., for diagnostic accuracy). The evaluation focuses on engineering performance and regulatory compliance for modified features.

4. Adjudication Method for the Test Set

Not applicable, as no expert adjudication of images or data to establish ground truth is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "There were not any clinical tests conducted to support the subject device and the substantial equivalence argument..." This is a software and hardware update, not a new diagnostic AI algorithm requiring such a study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable in the typical sense for a diagnostic AI algorithm. The software features are enhancements to an existing imaging system, not a standalone diagnostic algorithm. The "standalone" performance here relates to the technical functionality of the new features (e.g., whether the new sequences produce images correctly, whether MNO spectroscopy works on phantoms). These functional tests were performed in a standalone manner (without a human interpreting findings for diagnostic purposes).

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests was based on:

• Physical measurements and engineering specifications: For coil performance (SNR, uniformity, heating, hybrid mode).
• Phantom studies: For MNO Spectroscopy, where the phantom's known characteristics serve as the ground truth.
• NEMA NU:2 standards: For PET performance, adherence to these published standards serves as the ground truth for system performance.
• Software engineering requirements and specifications: For the verification and validation of all software features, ensuring they meet their design intent.

8. The Sample Size for the Training Set

Not applicable. This submission is for modifications to an existing MR-PET system software and hardware. The new software features described (e.g., reconstruction improvements, new sequences, usability improvements) are not typically "trained" in the machine learning sense from a large dataset but rather developed through traditional software engineering and signal processing methods.

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

Not applicable, as there is no mention of a "training set" in the context of machine learning for this device modification.

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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 system 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 oblique cross-sectional MRimages, 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 labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MRsafe 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 Biograph mMR systems are combined Magnetic Resonance Diagnostic Devices (MRDD) and Positron Emission Tomography (PET) scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph mMR systems provide reqistration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (MR and PET). Additional components of the system include: a patient bed and both, the acquisition and processing, workstations with associated software.

The Biograph mMR includes a 3T superconducting magnet, gradient coil, body coil and local RF coils based on those of the predicate MAGNETOM Verio 3T system. The Biograph mMR PET detectors have been updated from those of the predicate Biograph mCT to allow them to be integrated into the bore of the MR. This allows for simultaneous, precisely aligned whole body MR and PET acquisition.

Biograph mMR software is based on a combination of MAGNETOM Verio with B17 software, and Biograph mCT software. It is used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The Biograph mMR system, the subject of this application, is substantially equivalent to the commercially available devices above with modifications made to integrate the two modalities together into a whole-body system.

The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) premarket notification for the Siemens Biograph mMR, outlining its description, indications for use, and a letter from the FDA confirming substantial equivalence to predicate devices.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on establishing substantial equivalence based on the device's design, intended use, and compliance with recognized standards, rather than presenting a performance study with explicit acceptance criteria.

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