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AI-Rad Companion Brain MR is a post-processing image analysis software that assists clinicians in viewing, analyzing, and evaluating MR brain images.

AI-Rad Companion Brain MR provides the following functionalities:
• Automated segmentation and quantitative analysis of individual brain structures and white matter hyperintensities
• Quantitative comparison of each brain structure with normative data from a healthy population
• Presentation of results for reporting that includes all numerical values as well as visualization of these results

AI-Rad Companion Brain MR runs two distinct and independent algorithms for Brain Morphometry analysis and White Matter Hyperintensities (WMH) segmentation, respectively. In overall, comprises four main algorithmic features:

• Brain Morphometry
• Brain Morphometry follow-up
• White Matter Hyperintensities (WMH)
• White Matter Hyperintensities (WMH) follow-up

The feature for Brain Morphometry is available since the first version of the device (VA2x), while segmentation of White Matter Hyperintensities was added since VA4x and the follow-up analysis for both is available since VA5x. The brain morphometry and brain morphometry follow-up feature have not been modified and remain identical to previous VA5x mainline version.

AI-Rad Companion Brain MR VA60 is an enhancement to the predicate, AI-Rad Companion Brain MR VA50 (K232305). Just as in the predicate, the brain morphometry feature of AI-Rad Companion Brain MR addresses the automatic quantification and visual assessment of the volumetric properties of various brain structures based on T1 MPRAGE datasets. From a predefined list of brain structures (e.g. Hippocampus, Caudate, Left Frontal Gray Matter, etc.) volumetric properties are calculated as absolute and normalized volumes with respect to the total intracranial volume. The normalized values are compared against age-matched mean and standard deviations obtained from a population of healthy reference subjects. The deviation from this reference population can be visualized as 3D overlay map or out-of-range flag next to the quantitative values.

Additionally, identical to the predicate, the white matter hyperintensities feature addresses the automatic quantification and visual assessment of white matter hyperintensities on the basis of T1 MPRAGE and T2 weighted FLAIR datasets. The detected WMH can be visualized as a 3D overlay map and the quantification in count and volume as per 4 brain regions in the report.

Here's a structured overview of the acceptance criteria and study details for the AI-Rad Companion Brain MR, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • White Matter Hyperintensities (WMH) Feature: 100 subjects (Multiple Sclerosis patients (MS), Alzheimer's patients (AD), cognitive impaired (CI), and healthy controls (HC)).
   • White Matter Hyperintensities (WMH) Follow-up Feature: 165 subjects (Multiple Sclerosis patients (MS) and Alzheimer's patients (AD)).
   • Data Provenance: Data acquired from Siemens, GE, and Philips scanners. Testing data had balanced distribution with respect to gender and age of the patient according to target patient population, and field strength (1.5T and 3T). This indicates a retrospective, multi-vendor, multi-national (implied by vendor diversity) dataset.

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

   • Number of Experts: Three radiologists.
   • Qualifications: Not explicitly stated beyond "radiologists." It is not specified if they are board-certified, or their years of experience.

3. Adjudication Method for the Test Set:

   • For each dataset, three sets of ground truth annotations were created manually.
   • Each set was annotated by a disjoint group consisting of an annotator, a reviewer, and a clinical expert.
   • The clinical expert was randomly assigned per case to minimize annotation bias.
   • The clinical expert reviewed and corrected the initial annotation of the changed WMH areas according to a specified annotation protocol. Significant corrections led to re-communication with the annotator and re-review.
   • This suggests a 3+1 Adjudication process, where three initial annotations are reviewed by a clinical expert.

4. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

   • No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done. The study focuses on the standalone performance of the AI algorithm against expert ground truth.

5. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:

   • Yes, a standalone performance study was done. The "Accuracy was validated by comparing the results of the device to manual annotated ground truth from three radiologists." This evaluates the algorithm's performance directly.

6. The Type of Ground Truth Used:

   • Expert Consensus / Manual Annotation: The ground truth for both WMH and WMH follow-up features was established through "manual annotated ground truth from three radiologists" and involved a "standard annotation process" with annotators, reviewers, and clinical experts.

7. The Sample Size for the Training Set:

   • The document states that the "training data used for the fine tuning the hyper parameters of WMH follow-up algorithm is independent of the data used to test the white matter hyperintensity algorithm follow up algorithm." However, the specific sample size for the training set is not provided in the given text.

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

   • The document implies that the WMH follow-up algorithm "does not include any machine learning/ deep learning component," suggesting a rule-based or conventional image processing algorithm. Therefore, "training" might refer to parameter tuning rather than machine learning model training.
   • For the "fine-tuning the hyper parameters of WMH follow-up algorithm," the ground truth establishment method for this training data is not explicitly detailed in the provided text. It only states that this data was "independent of the data used to test" the algorithm.

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Magnetic Resonance Imaging (MRI) is a noninvasive technique used for diagnostic imaging. MRI with its soft tissue contrast capability enables the healthcare professional to differentiate between various soft tissues, for example, fat, water, and muscle, but can also visualize bone structures.

Depending on the region of interest, contrast agents may be used.

The MR system may also be used for imaging during interventional procedures and radiation therapy planning.

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

BIOGRAPH One with software Syngo MR XB10 includes new and modified hardware and software compared to the predicate device, Biograph mMR with software syngo MR E11P-AP01. A high level summary of the new and modified hardware and software is provided below:

Hardware

New Hardware

• Gantry offset phantom
• SDB (Smart Distribution Box)

New Coils

• BM Contour XL Coil
• BM Head/Neck Pro PET-MR Coil
• BM Spine Pro PET-MR Coil
• Transfer of up-to-date RF coils from the reference device MAGNETOM Vida.

Modified Hardware

• Main components such as:
  • Detector cassettes / DEA
  • Phantom holder
  • Gantry tube
  • Backplane
  • Magnet and cabling
  • Gradient coil
  • MaRS (measurement and reconstruction system)
  • MI MARS
  • PET electronics
  • RF transmitter TBX3 3T (TX Box 3)
• Other components such as:
  • Cover
  • Filter plate
  • Patient table
  • RFCEL_TEMP

Modified Coils

• Body coil
• Transfer of up-to-date RF coils from the reference device MAGNETOM Vida with some improvements.

Software

New Features and Applications

• Fast Whole-Body workflows
• Fast Head workflow
• myExam PET-MR Assist
• CS-Vibe
• myExam Implant Suite
• DANTE blood suppression
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS without diffusion function
• BioMatrix Motion Sensor
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• ASNR recommended protocols for imaging of ARIA
• Open Workflow
• Ultra HD-PET
• "MTC Mode"
• OpenRecon 2.0
• Deep Resolve Boost for TSE
• GRE_PC
• The following functions have been migrated for the subject device without modifications from MAGNETOM Skyra Fit and MAGNETOM Sola Fit:
  • 3D Whole Heart
• Ghost reduction (Dual polarity Grappa (DPG))
• Fleet Reference Scan
• AutoMate Cardiac (Cardiac AI Scan Companion)
• Complex Averaging
• SPACE Improvement: high bandwidth IR pulse
• SPACE Improvement: increase gradient spoiling
• The following function has been migrated for the subject device without modifications from MAGNETOM Free.Max:
  • myExam Autopilot Spine
• The following functions have been migrated for the subject device without modifications from MAGNETOM Sola:
  • myExam Autopilot Brain
  • myExam Autopilot Knee
• Transfer of further up-to-date SW functions from the reference devices.

New Software / Platform

• PET-Compatible Coil Setup
• Select&GO
• PET-MR components communication

Modified Features and Applications

• HASTE_CT
• FL3D_VIBE_AC
• PET Reconstruction
• Transfer of further up-to-date SW functions from the reference devices with some improvements.

Modified Software / Platform

• Several software functions have been improved. Which are:
  • PET Group
  • PET Viewing
  • PET RetroRecon
  • PET Status and Tune-up/QA

Other Modifications and / or Minor Changes

• Indications for use
• Contraindications
• SAR parameter
• Off-Center Planning Support
• Flip Angle Optimization (Lock TR and FA)
• Inline Image Filter
• Marketing bundle "myExam Companion"
• ID Gain
• Automatic System Shutdown (ASS) sensor (Smoke Detector)
• Patient data display (PDD)

The FDA 510(k) Clearance Letter for BIOGRAPH One refers to several AI/Deep Learning features. However, the provided document does not contain explicit acceptance criteria for these AI features in a table format, nor does it detail a comparative effectiveness study (MRMC study) for human readers. It primarily focuses on demonstrating non-inferiority to the predicate device through various non-clinical tests.

Below is an attempt to extract and synthesize the information based on the provided text, while acknowledging gaps in the information regarding specific acceptance criteria metrics and clinical studies.

Acceptance Criteria and Study Details for BIOGRAPH One AI Features

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a dedicated table format. Instead, it describes performance in terms of achieving "convergence of the training" and "improvements compared to conventional parallel imaging," or confirming "very similar metrics" to the predicate. The "acceptance criteria" are implied by these statements and the successful completion of the described tests.

2. Sample Sizes Used for Test Set and Data Provenance

The document primarily describes a validation dataset which serves as the "test set" for the AI models during development, and an additional "test dataset" for specific evaluations.

• Deep Resolve Boost for FL3D_VIBE and SPACE:

  • Test Set Description: The "collaboration partners (testing)" data is mentioned as the source for testing, implying an external, independent test set. No specific number for this test set is provided beyond the 1265 measurements for training/validation.
  • Sample Size (Validation/Training): 27,679 3D patches from 1265 measurements.
  • Data Provenance: "in-house measurements (training and validation) and collaboration partners (testing)." The country of origin is not specified but is likely Germany (Siemens Healthineers AG) and/or China (Siemens Shenzhen Magnetic Resonance LTD.) where the manufacturing is listed.
  • Retrospective/Prospective: "Input data was retrospectively created from the ground truth by data manipulation and augmentation." This indicates retrospective data use.

• Deep Resolve Sharp for FL3D_VIBE and SPACE:

  • Test Set Description: The document states, "The high-resolution datasets were split to 70% training and 30% validation datasets before training to ensure independence of them." This implies the 30% validation dataset is used as the test set.
  • Sample Size (Validation/Training): 27,679 3D patches from 1265 measurements (split into 70% training and 30% validation).
  • Data Provenance: "in-house measurements (training and validation) and collaboration partners (testing)."
  • Retrospective/Prospective: "Input data was retrospectively created from the ground truth by data manipulation." This indicates retrospective data use.

• Deep Resolve Boost for TSE (First Mention - General Performance):

  • Test Set Description: The "evaluation on the test dataset" is mentioned. The validation set is 30% of the 500 measurements.
  • Sample Size (Validation/Training): Approximately 13,000 high resolution 3D patches from 500 measurements (split into 70% training and 30% validation).
  • Data Provenance: "in-house measurements."
  • Retrospective/Prospective: "Input data was retrospectively created from the ground truth by data manipulation." This indicates retrospective data use.

• Deep Resolve Boost for TSE (Second Mention - Banding Artifacts):

  • Test Set Description: "Additional test dataset for banding artifact reduction: more than 2000 slices." This dataset was acquired after the release of the predicate network.
  • Sample Size: More than 2000 slices.
  • Data Provenance: "in-house measurements and collaboration partners."
  • Retrospective/Prospective: Not explicitly stated for this specific additional dataset, but the training/validation data for the predicate was retrospective.

3. Number of Experts and Qualifications for Ground Truth

• Radiologist Evaluation for Deep Resolve Boost for TSE (Second Mention): The document mentions "the radiologist evaluation revealed no difference in suitability for clinical diagnostics."

  • Number of Experts: Not specified (singular "radiologist" used, but typically multiple are implied for such evaluations).
  • Qualifications: "Radiologist." No specific years of experience or subspecialty are mentioned.

• Other features: For Deep Resolve Boost/Sharp for FL3D_VIBE and SPACE, and Deep Resolve Boost for TSE (first mention), the ground truth is derived directly from acquired image data (see section 7). No independent human expert ground truth establishment for these.

4. Adjudication Method (for Test Set)

• Radiologist Evaluation for Deep Resolve Boost for TSE (Second Mention): The adjudication method is not specified in the document (e.g., 2+1, 3+1). It only states "the radiologist evaluation."

• Other features: Adjudication methods are not applicable as human experts were not establishing ground truth for objective metrics.

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

• Was an MRMC study done? No, the document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is compared. The evaluation for Deep Resolve Boost for TSE mentions "radiologist evaluation" but not in a comparative MRMC study context.
• Effect Size: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only) Performance

• Was standalone performance done? Yes, the performance testing for all Deep Resolve features (Boost and Sharp for FL3D_VIBE, SPACE, and TSE) was conducted "algorithm only" by evaluating metrics like PSNR, SSIM, MSE, and LPIPS, and then visual inspection/radiologist evaluation. These refer to the algorithm's direct output performance.

7. Type of Ground Truth Used

• Deep Resolve Boost for FL3D_VIBE and SPACE: "The acquired datasets (as described above) represent the ground truth for the training and validation."
• Deep Resolve Sharp for FL3D_VIBE and SPACE: "The acquired datasets represent the ground truth for the training and validation." Input data was manipulated (cropped k-space) to create low-resolution input and high-resolution output/ground truth from the same dataset.
• Deep Resolve Boost for TSE (First Mention): "The acquired datasets represent the ground truth for the training and validation." Input data was manipulated (cropped k-space) to create low-resolution input and high-resolution output/ground truth from the same dataset.
• Deep Resolve Boost for TSE (Second Mention): "The acquired training/validation datasets... represent the ground truth for the training and validation." Input data was manipulated by undersampling k-space, adding noise, and mirroring k-space.
• Summary: The ground truth for all AI features was derived from acquired, high-resolution original image data (retrospectively manipulated to simulate inputs). For Deep Resolve Boost for TSE (second mention), there was also an implicit "expert consensus" or "expert reading" component for the "radiologist evaluation" regarding clinical suitability.

8. Sample Size for the Training Set

• Deep Resolve Boost for FL3D_VIBE and SPACE: 81% of 1265 measurements (for 27,679 3D patches).
• Deep Resolve Sharp for FL3D_VIBE and SPACE: 70% of 1265 measurements (for 27,679 3D patches).
• Deep Resolve Boost for TSE (First Mention): 70% of 500 measurements (for approx. 13,000 high resolution 3D patches).
• Deep Resolve Boost for TSE (Second Mention): More than 23,250 slices (93% of the combined training/validation dataset from K213693).

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

• Deep Resolve Boost for FL3D_VIBE and SPACE: The "acquired datasets" represent the ground truth. "Input data was retrospectively created from the ground truth by data manipulation and augmentation. This process includes further undersampling of the data by discarding k-space lines as well as creating sub-volumes of the acquired data."
• Deep Resolve Sharp for FL3D_VIBE and SPACE: The "acquired datasets represent the ground truth." "Input data was retrospectively created from the ground truth by data manipulation. k-space data has been cropped such that only the center part of the data was used as input. With this method corresponding low-resolution data as input and high-resolution data as output / ground truth were created for training and validation."
• Deep Resolve Boost for TSE (First Mention): Similar to Deep Resolve Sharp for FL3D_VIBE and SPACE: "The acquired datasets represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation. k-space data has been cropped such that only the center part of the data was used as input. With this method corresponding low-resolution data as input and high-resolution data as output / ground truth were created for training and validation."
• Deep Resolve Boost for TSE (Second Mention): "The acquired training/validation datasets... represent the ground truth for the training and validation. Input data was retrospectively created from the ground truth by data manipulation and augmentation. This process includes further undersampling of the data by discarding k-space lines, lowering of the SNR level by addition of noise and mirroring of k-space data."

In summary, for all AI features, the ground truth for training was established by using high-quality, originally acquired MRI data that was then retrospectively manipulated (e.g., undersampled, cropped, noise added) to create synthetic "lower quality" input data for the AI model to learn from, with the original high-quality data serving as the target output or ground truth.

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Atellica IM total PSA II (tPSAII) assay is for in vitro diagnostic use in the quantitative measurement of total prostate-specific antigen (PSA) in human serum and plasma (EDTA and lithium-heparin) using the Atellica IM Analyzer.

This assay is indicated as an aid in the detection of prostate cancer in conjunction with a digital rectal exam (DRE) in men aged 50 years and older. Prostate biopsy is required for diagnosis of prostate cancer. This assay is further indicated as an aid in the management (monitoring) of patients with prostate cancer.

The Atellica IM total PSA II (tPSAII) assay consists of:

tPSAII ReadyPack® primary reagent pack

• Lite Reagent (10.0 mL/reagent pack): Unlabeled monoclonal mouse anti-fPSA antibody (~250 ng/mL); monoclonal mouse anti-PSA antibody (~180 ng/mL) labeled with acridinium ester; buffer; bovine serum albumin (BSA); preservative.
• Solid Phase (20.0 mL/reagent pack): Monoclonal mouse anti-PSA antibody (~3.5 μg/mL) labeled with biotin and bound to streptavidin paramagnetic particles; buffer; BSA; bovine gamma globulin (BGG); sodium azide (< 0.1%); preservative.
  • Storage: Unopened at 2–8°C (Until expiration date on product), Onboard (42 days).

tPSAII CAL (2.0 mL/vial): Purified PSA from human seminal fluid in buffer; BSA; NaN3 (< 0.1%).

• Storage: Unopened at 2–8°C (Until expiration date on product), Opened at 2–8°C (30 days), On the system at room temperature (8 hours).

The tPSAII assay will have two configurations: 100 tests kit and 500 tests kit (5 x 100T in the carton).

N/A

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Intended Use / Indications for Use

Indications for Use for MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit, MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit, MAGNETOM Viato.Mobile:

The 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 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 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.

Indications for Use for MAGNETOM Flow.Elite, MAGNETOM Flow.Neo, MAGNETOM Flow.Rise:

The 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, depending on optional local coils that have been configured with the system, 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.

The 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.

The subject device, MAGNETOM Vida with software Syngo MR XB10, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Vida with syngo MR XA60A (K231560).

A high-level summary of the new and modified hardware and software is provided below:

New Hardware:

• myExam 3D Camera
• BM Contour XL Coil

Modified Hardware:

• RF Transmitter TBX3 3T (TX Box 3)
• MaRS (Measurement and reconstruction system)

Software

New Features and Applications:

• Brachytherapy Support for use with MR conditional applicators
• CS Vibe
• myExam Implant Suite
• DANTE blood suppression
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS for BLADE without diffusion function
• BioMatrix Motion Sensor
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• ASNR recommended protocols for imaging of ARIA
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• 3D Whole Heart
• Ghost reduction (Dual polarity Grappa (DPG))
• Fleet Reference Scan
• AutoMate Cardiac (Cardiac AI Scan Companion)
• Complex Averaging
• myExam Autopilot Spine
• myExam Autopilot Brain and myExam Autopilot Knee
• Open Workflow

Modified features and applications:

• GRE_PC
• myExam RT Assist workflow improvements
• Open Recon 2.0
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE
• SPACE Improvement: high bandwidth IR pulse
• SPACE Improvement: increase gradient spoiling

The subject device, MAGNETOM Lumina with software Syngo MR XB10, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Lumina with syngo MR XA60A (K231560). A high-level summary of the new and modified hardware and software is provided below:

New Hardware:

• myExam 3D Camera
• BM Contour XL Coil

Modified Hardware:

• RF Transmitter TBX3 3T (TX Box 3)
• MaRS (Measurement and reconstruction system)

Software

New Features and Applications:

• CS Vibe
• myExam Implant Suite
• DANTE blood suppression
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS for BLADE without diffusion function
• BioMatrix Motion Sensor
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• Ghost reduction (Dual polarity Grappa (DPG))
• Fleet Reference Scan
• AutoMate Cardiac (Cardiac AI Scan Companion)
• Complex Averaging
• myExam Autopilot Spine
• myExam Autopilot Brain and myExam Autopilot Knee
• Compressed Sensing Cardiac Cine
• Open Workflow

Modified Features and Applications:

• GRE_PC
• Open Recon 2.0
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE
• SPACE Improvement: high bandwidth IR pulse
• SPACE Improvement: increase gradient spoiling

The subject device, MAGNETOM Lumina with software Syngo MR XB10, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Lumina with syngo MR XA60A (K231560). A high-level summary of the new and modified hardware and software is provided below:

New Hardware:

• myExam 3D Camera
• BM Contour XL Coil

Modified Hardware:

• RF Transmitter TBX3 3T (TX Box 3)
• MaRS (Measurement and reconstruction system)

Software

New Features and Applications:

• CS Vibe
• myExam Implant Suite
• DANTE blood suppression
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS for BLADE without diffusion function
• BioMatrix Motion Sensor
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• Ghost reduction (Dual polarity Grappa (DPG))
• Fleet Reference Scan
• AutoMate Cardiac (Cardiac AI Scan Companion)
• Complex Averaging
• myExam Autopilot Spine
• myExam Autopilot Brain and myExam Autopilot Knee
• Compressed Sensing Cardiac Cine
• Open Workflow

Modified Features and Applications:

• GRE_PC
• Open Recon 2.0
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE
• SPACE Improvement: high bandwidth IR pulse
• SPACE Improvement: increase gradient spoiling

The subject device, MAGNETOM Vida Fit with software Syngo MR XB10, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Vida with syngo MR XA60A (K231560).

A high-level summary of the new and modified hardware and software is provided below:

New Hardware:

• myExam 3D Camera
• Beat Sensor
• BM Contour XL Coil

Modified Hardware:

• RF Transmitter TBX3 3T (TX Box 3)
• MaRS (Measurement and reconstruction system)
• Host computers

Software

New Features and Applications:

• Brachytherapy Support for use with MR conditional applicators
• CS Vibe
• myExam Implant Suite
• DANTE blood suppression
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS for BLADE without diffusion function
• BioMatrix Motion Sensor
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• ASNR recommended protocols for imaging of ARIA
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• GRE_PC
• Open Recon 2.0
• 3D Whole Heart
• Ghost reduction (Dual polarity Grappa (DPG))
• Fleet Reference Scan
• AutoMate Cardiac (Cardiac AI Scan Companion)
• myExam Autopilot Spine
• myExam Autopilot Brain and myExam Autopilot Knee
• Deep Resolve for EPI
• Deep Resolve for HASTE
• Physiologging
• Complex Averaging
• Open Workflow

Modified features and applications:

• myExam RT Assist workflow improvements
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE
• myExam Angio Advanced Assist (Test Bolus)
• SPACE Improvement: high bandwidth IR pulse
• SPACE Improvement: increase gradient spoiling

The subject device, MAGNETOM Sola with software Syngo MR XB10, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola with syngo MR XA61A (K232535).

A high-level summary of the new and modified hardware and software is provided below:

New Hardware:

• BM Contour XL Coil

Modified Hardware:

• MaRS (Measurement and reconstruction system)

Software

New Features and Applications:

• Brachytherapy Support for use with MR conditional applicators
• CS Vibe
• DANTE blood suppression
• BioMatrix Motion Sensor
• SPAIR FatSat Improvements: SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• ASNR recommended protocols for imaging of ARIA
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• 3D Whole Heart
• AutoMate Cardiac (Cardiac AI Scan Companion)
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS for BLADE without diffusion function
• Ghost reduction (Dual polarity Grappa (DPG))
• Fleet Reference Scan
• Deep Resolve Swift Brain
• myExam Autopilot Spine
• Open Workflow
• Complex Averaging
• Open Workflow

Modified features and applications:

• myExam RT Assist workflow improvements
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE
• myExam Angio Advanced Assist (Test Bolus)
• SPACE Improvement: high bandwidth IR pulse
• SPACE Improvement: increase gradient spoiling

The subject device, MAGNETOM Sola with software Syngo MR XB10, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola with syngo MR XA61A (K232535).

A high-level summary of the new and modified hardware and software is provided below:

New Hardware:

• BM Contour XL Coil

Modified Hardware:

• MaRS (Measurement and reconstruction system)

Software

New Features and Applications:

• Brachytherapy Support for use with MR conditional applicators
• CS Vibe
• DANTE blood suppression
• BioMatrix Motion Sensor
• SPAIR FatSat Improvements: SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• ASNR recommended protocols for imaging of ARIA
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• 3D Whole Heart
• AutoMate Cardiac (Cardiac AI Scan Companion)
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS for BLADE without diffusion function
• Ghost reduction (Dual polarity Grappa (DPG))
• Fleet Reference Scan
• Deep Resolve Swift Brain
• myExam Autopilot Spine
• Open Workflow

Modified features and applications:

• myExam Implant Suite
• GRE_PC
• myExam RT Assist workflow improvements
• Open Recon 2.0
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE
• SPACE Improvement: high bandwidth IR pulse
• SPACE Improvement: increase gradient spoiling

The subject device, MAGNETOM Altea with software Syngo MR XB10, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Altea with syngo MR XA61A (K232535).

A high-level summary of the new and modified hardware and software is provided below:

New Hardware:

• BM Contour XL Coil

Modified Hardware:

• MaRS (Measurement and reconstruction system)

Software

New Features and Applications:

• CS Vibe
• DANTE blood suppression
• BioMatrix Motion Sensor
• SPAIR FatSat Improvements: SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• AutoMate Cardiac (Cardiac AI Scan Companion)
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS for BLADE without diffusion function
• Ghost reduction (Dual polarity Grappa (DPG))
• Fleet Reference Scan
• Deep Resolve Swift Brain
• myExam Autopilot Spine
• Compressed Sensing Cardiac Cine
• Open Workflow

Modified features and applications:

• myExam Implant Suite
• GRE_PC
• myExam RT Assist workflow improvements
• Open Recon 2.0
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE
• SPACE Improvement: high bandwidth IR pulse
• SPACE Improvement: increase gradient spoiling

The subject device, MAGNETOM Sola Fit with software Syngo MR XB10, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola Fit with syngo MR XA70A (K250443).

A high-level summary of the new and modified hardware and software is provided below:

New Hardware:

• BM Contour XL Coil

Modified Hardware:

• MaRS (Measurement and reconstruction system)
• Host computers

Software

New Features and Applications:

• Brachytherapy Support for use with MR conditional applicators
• CS Vibe
• DANTE blood suppression
• BioMatrix Motion Sensor
• SPAIR FatSat Improvements: SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• ASNR recommended protocols for imaging of ARIA
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• myExam Implant Suite
• GRE_PC
• Open Recon 2.0
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS for BLADE without diffusion function
• Deep Resolve Swift Brain
• myExam Autopilot Spine
• Open Workflow

Modified features and applications:

• myExam RT Assist workflow improvements
• myExam Implant Suite
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE
• SPACE Improvement: high bandwidth IR pulse
• SPACE Improvement: increase gradient spoiling

The subject device, MAGNETOM Sola Fit with software Syngo MR XB10, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola Fit with syngo MR XA70A (K250443).

A high-level summary of the new and modified hardware and software is provided below:

New Hardware:

• BM Contour XL Coil

Modified Hardware:

• MaRS (Measurement and reconstruction system)
• Host computers

Software

New Features and Applications:

• Brachytherapy Support for use with MR conditional applicators
• CS Vibe
• DANTE blood suppression
• BioMatrix Motion Sensor
• SPAIR FatSat Improvements: SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• ASNR recommended protocols for imaging of ARIA
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• myExam Implant Suite
• GRE_PC
• Open Recon 2.0
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS for BLADE without diffusion function
• Deep Resolve Swift Brain
• myExam Autopilot Spine
• Open Workflow

Modified features and applications:

• myExam RT Assist workflow improvements
• myExam Implant Suite
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE

The subject device, MAGNETOM Viato.Mobile with software Syngo MR XB10, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Viato.Mobile with syngo MR XA70A (K250443).

A high-level summary of the new and modified hardware and software is provided below:

New Hardware:

• BM Contour XL Coil

Modified Hardware:

• MaRS (Measurement and reconstruction system)
• Host computers

Software

New Features and Applications:

• CS Vibe
• DANTE blood suppression
• BioMatrix Motion Sensor
• SPAIR FatSat Improvements: SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
• RF pulse optimization with VERSE
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• ASNR recommended protocols for imaging of ARIA
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• myExam Implant Suite
• GRE_PC
• Open Recon 2.0
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS for BLADE without diffusion function
• Deep Resolve Swift Brain
• myExam Autopilot Spine
• Open Workflow

Modified features and applications:

• myExam Implant Suite
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE

With the subject software version, Syngo MR XB10, we are also introducing the following new 1.5T devices, which are part of our MAGNETOM Flow. Platform:

MAGNETOM Flow.Elite
MAGNETOM Flow.Neo
MAGNETOM Flow.Rise

The subject device, MAGNETOM Flow.Elite, MAGNETOM Flow.Neo and MAGNETOM Flow.Rise with software Syngo MR XB10, consists of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Sola with syngo MR XA61A (K232535).

A high-level summary of the new and modified hardware and software is provided below:

New Hardware:

• Magnet
• MREF (Magnet Refrigerator)
• Gradient system
• Gradient Coil
• RF System
• System Cover
• Patient Table
• MaRS (Measurement and Reconstruction System)
• Select&GO Display (TPAN_3G) and Control Panel (CPAN_2G)
• Body Coil
• Head/Neck Coil
• BM Head/Neck Coil (with ComfortSound)
• BM Contour S Coil
• BM Contour M Coil
• BM Contour L Coil
• BM Contour XL Coil
• Foot/Ankle Coil
• BM Spine Coil
• iTx Extremity 18 Flare
• Multi-Index MR-RT Positioning (a part of "RT Pro Edition" marketing bundle) (not available for MAGNETOM Flow.Rise)

Modified Hardware:

• Gradient Power Amplifier (GPA)
• SAR Monitoring
• In-Vivo Shim

Software

New Features and Applications:

• CS Vibe
• BioMatrix Motion Sensor
• SPAIR FatSat Improvements: SPAIR "Abdomen&Pelvis" mode and SPAIR Breast mode
• Deep Resolve Boost for FL3D_VIBE and SPACE
• Deep Resolve Sharp for FL3D_VIBE and SPACE
• Preview functionality for Deep Resolve Boost
• EP2D_FID_PHS
• EP_SEG_FID_PHS
• AutoMate Cardiac (Cardiac AI Scan Companion)
• DANTE blood suppression
• SMS Averaging for TSE
• SMS Averaging for TSE_DIXON
• SMS for BLADE without diffusion function
• Ghost reduction (Dual polarity Grappa (DPG))
• Fleet Reference Scan
• Deep Resolve Swift Brain
• Quick Protocols
• myExam Autopilot Spine
• Open Workflow

Modified features and applications:

• myExam Implant Suite
• GRE_PC
• myExam RT Assist workflow improvements (not available for MAGNETOM Flow.Rise)
• Open Recon 2.0
• Deep Resolve Boost for TSE
• "MTC Mode" for SPACE
• SPACE Improvement: high bandwidth IR pulse
• SPACE Improvement: increase gradient spoiling

New (general) Software / Platform / Workflow:

• Select&GO extension (coil-based Iso Centering, Patient Registration at the touch display, Start Scan at the touch display)
• New Startup-Timer
• myExam RT Assist (not available for MAGNETOM Flow.Rise)
• myExam Brain RT-Autopilot (not available for MAGNETOM Flow.Rise)
• Eco Power Mode Pro

Modified (general) Software / Platform:

• Improved Gradient ECO Mode Settings

Furthermore, the following minor updates and changes were conducted for the subject devices MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit, MAGNETOM Sola, MAGNETOM Altea:

• Off-Center Planning Support
• Flip Angle Optimization (Lock TR and FA)
• Inline Image Filter
• Automatic System Shutdown (ASS) sensor (Smoke Detector)
• ID Gain (re-naming)
• Select&Go Display (Touch Display (TPAN))
• Marketing bundle "myExam Companion"

The following minor updates and changes were conducted for the subject devices MAGNETOM Sola Fit and MAGNETOM Viato.Mobile:

• Off-Center Planning Support
• Automatic System Shutdown (ASS) sensor (Smoke Detector)
• ID Gain (re-naming)
• Select&Go Display (Touch Display (TPAN))
• Marketing bundle "myExam Companion"

The following minor updates and changes were conducted for the subject devices MAGNETOM Flow.Elite, MAGNETOM Flow.Neo, MAGNETOM Flow.Rise:

• Off-Center Planning Support
• Flip Angle Optimization (Lock TR and FA)
• Inline Image Filter
• Automatic System Shutdown (ASS) sensor (Smoke Detector)
• ID Gain (re-naming)
• Marketing bundle "myExam Companion"
• Marketing Bundle "RT Pro Edition"(not available for MAGNETOM Flow.Rise)

This FDA 510(k) clearance letter pertains to several MAGNETOM MRI systems with software Syngo MR XB10. The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing of new and modified hardware and software features, particularly those involving Artificial Intelligence (AI) such as "Deep Resolve" functionalities.

Here's an analysis of the acceptance criteria and the studies that prove the devices meet them, specifically for the AI features:

1. Table of Acceptance Criteria and Reported Device Performance for AI Features

The document does not explicitly state "acceptance criteria" for the AI features in a numerical format that would typically be seen for a device's performance metrics (e.g., minimum sensitivity, specificity). Instead, the acceptance criteria are implicitly defined by the evaluation methods and the "Test result summary" for each Deep Resolve feature, which aim to demonstrate equivalent or improved image quality compared to conventional methods.

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

Since the document distinguishes between training, validation, and testing datasets, the "test set" here refers to the data used for final evaluation of the AI model's performance.

• Deep Resolve Swift Brain:

  • Test Set Sample Size: The document lists "Validation: 3,616 slices (1.5T validation); 6,048 slices (3T validation)" as part of the split. It also mentions "work-in-progress packages of the network were delivered and evaluated in clinical settings with collaboration partners," implying additional testing, but a specific numerical sample size for this external validation is not provided in detail. However, the initial splits serve as the primary "test set" for performance metrics mentioned.
  • Data Provenance: "in-house measurement," implying retrospective data collected at Siemens' facilities. The document notes that "attributes like gender, age and ethnicity are not relevant to the training data" due to network architecture, but no specific country of origin is stated beyond "in-house."

• Deep Resolve Boost for FL3D_VIBE and Deep Resolve Boost for SPACE:

  • Test Set Sample Size: The document states 19% of 1265 measurements for validation. It also explicitly mentions "collaboration partners (testing)" indicating an external test set, but a specific numerical breakdown for this is not provided.
  • Data Provenance: "in-house measurements (training and validation) and collaboration partners (testing)." This suggests a mix of retrospective data potentially from various countries where Siemens has collaboration, though specific locations are not listed.

• Deep Resolve Sharp for FL3D_VIBE and Deep Resolve Sharp for SPACE:

  • Test Set Sample Size: 30% of the 500 measurements are listed for validation, which serves as a test set. This equates to 150 measurements.
  • Data Provenance: "in-house measurements," implying retrospective data from Siemens' research facilities. Specific country not mentioned.

• Deep Resolve Boost for TSE:

  • Test Set Sample Size: "Additional test dataset for banding artifact reduction: more than 2000 slices."
  • Data Provenance: "in-house measurements and collaboration partners" for training/validation. The "additional test dataset for banding artifact reduction" likely follows the same provenance. Retrospective data.

3. Number of Experts Used and Qualifications for Ground Truth

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience") for any of the Deep Resolve features.

However, for Deep Resolve Boost for TSE, it mentions:

• "Visual evaluations confirmed statistically significant reduction of banding artifacts... "
• "In addition, the radiologist evaluation revealed no difference in suitability for clinical diagnostics..."

This indicates that radiologists were involved in the evaluation of the Deep Resolve Boost for TSE feature, presumably as experts to establish the clinical suitability. The exact number and their detailed qualifications are not provided. For other features, the ground truth is primarily based on the acquired raw data or manipulated versions of it, without explicit mention of expert review in the ground truth establishment process.

4. Adjudication Method (for the test set)

The document does not specify an adjudication method like "2+1" or "3+1" for establishing ground truth or evaluating the test set for any of the AI features. The ground truth for training and validation is derived from the "acquired datasets" which are considered the ground truth due to data manipulation and augmentation from these high-quality source images. For Deep Resolve Boost for TSE, a "radiologist evaluation" is mentioned, implying expert review without detailing a specific adjudication protocol.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done to measure the improvement of human readers with AI assistance versus without AI assistance. The evaluations focus on the standalone performance of the AI algorithms in improving image quality metrics and, in one instance (Deep Resolve Boost for TSE, radiologist evaluation), the suitability for clinical diagnostics, rather than the impact on human reader performance.

6. Standalone (Algorithm Only) Performance

Yes, standalone (algorithm only) performance was done. The descriptions for each Deep Resolve feature focus entirely on the algorithm's performance in terms of quantitative image quality metrics (PSNR, SSIM, NMSE, MSE, LPIPS), visual inspection for artifacts, and improvements over conventional techniques. There is no mention of a "human-in-the-loop" component in the described performance evaluations for these AI features, except for the "radiologist evaluation" for Deep Resolve Boost for TSE which assessed clinical suitability of the output images, not reader performance with the AI.

7. Type of Ground Truth Used

• For Deep Resolve Swift Brain, Deep Resolve Boost for FL3D_VIBE & SPACE, and Deep Resolve Sharp for FL3D_VIBE & SPACE:

  • The ground truth used was the acquired datasets (raw MRI data). The input data for the AI models was then "retrospectively created from the ground truth by data manipulation and augmentation" (e.g., undersampling k-space, adding noise, cropping, creating sub-volumes, cropping k-space to simulate low-resolution input from high-resolution output). This means the AI models were trained to learn the mapping from manipulated (e.g., noisy, low-resolution, undersampled) inputs to the original, high-quality acquired image data.

• For Deep Resolve Boost for TSE:

  • Similar to above, the "acquired training/validation datasets" were considered the ground truth. Input data was generated by "data manipulation and augmentation" (e.g., discarding k-space lines, lowering SNR, mirroring k-space data).

In essence, the AI models are trained to restore or enhance images to resemble the high-quality, fully acquired MRI data that serves as the reference ground truth.

8. Sample Size for the Training Set

• Deep Resolve Swift Brain: 20,076 slices
• Deep Resolve Boost for FL3D_VIBE and Deep Resolve Boost for SPACE: 81% of 1265 measurements. (This equates to approximately 1024 measurements).
• Deep Resolve Sharp for FL3D_VIBE and Deep Resolve Sharp for SPACE: 70% of 500 measurements. (This equates to 350 measurements).
• Deep Resolve Boost for TSE: More than 23,250 slices (93% of the total dataset).

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

For all Deep Resolve features, the ground truth for the training set was established from acquired MRI datasets (either "in-house measurements" or from "collaboration partners"). These acquired datasets are implicitly considered the "true" or "high-quality" images. The AI models are designed to process inputs that mimic suboptimal acquisition conditions (e.g., undersampled k-space, lower SNR, lower resolution) and generate outputs that match these high-quality acquired images, which serve as the ground truth for learning. The process involved:

• Retrospective creation: Input data was created retrospectively from the acquired ground truth data.
• Data manipulation and augmentation: This involved techniques such as:
  • Discarding k-space lines (undersampling).
  • Lowering the SNR level by adding Gaussian noise to k-space data.
  • Uniformly-random cropping of training data.
  • Creating sub-volumes of acquired data.
  • Cropping k-space to generate low-resolution inputs corresponding to high-resolution ground truth.
  • Mirroring of k-space data.

This approach demonstrates an unsupervised or self-supervised learning paradigm where the ground truth is derived directly from the complete and high-fidelity raw data, and the AI is trained to reconstruct or enhance images from degraded inputs to match this ideal ground truth.

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The ADVIA Centaur Anti-Thyroglobulin II (aTgII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroglobulin in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system.

Anti-thyroglobulin (aTg) measurements are used, in conjunction with clinical assessment, as an aid in the diagnosis of autoimmune thyroiditis and Graves' disease.

N/A

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MAGNETOM Free.Max:
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images that display, depending on optional local coils that have been configured with the system, the internal structure and/or function of the head, body or extremities.

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

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

When operated by dentists and dental assistants trained in MRI, the MAGNETOM MR system must only be used for scanning the dentomaxillofacial region.

MAGNETOM Free.Star:
The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross-sectional images that display, depending on optional local coils that have been configured with the system, the internal structure and/or function of the head, body or extremities.

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

The subject devices MAGNETOM Free.Max and MAGNETOM Free.Star with software version syngo MR XA80A, consists of new and modified hardware and software features comparing to the predicate device MAGNETOM Free.Max and MAGNETOM Free.Star with software version syngo MR XA60A (K231617).

New hardware features (Only for MAGNETOM Free.Max):

• Dental coil
• High-end host
• syngo Workplace

Modified hardware features:

• MaRS
• Select&GO Display (TPAN_3G)

New Pulse Sequences/ Software Features / Applications:

Only for MAGNETOM Free.Max:

• EP_SEG_FID_PHS
• EP2D_FID_PHS
• EP_SEG_PHS
• GRE_Proj
• GRE_PHS
• myExam Dental Assist
• Select&GO Dental
• Slice Overlapping

For both MAGNETOM Free.Max and MAGNETOM Free.Star:

• Eco Power Mode
• Extended Gradient Eco Mode
• System Startup Timer

Modified Features and Applications:

• myExam RT Assist (only for MAGNETOM Free.Max)
• Deep Resolve for HASTE
• Deep Resolve for EPI Diffusion
• Select&GO for dental (only for MAGNETOM Free.Max)
• Select&GO extension: Patient Registration and Start Scan
• SPACE improvement: MTC prep module

Other Modifications and Minor Changes:

• MAGNETOM Free.Max Dental Edition marketing bundle (only for MAGNETOM Free.Max)
• MAGNETOM Free.Max RT Pro Edition marketing bundle (only for MAGNETOM Free.Max)
• Off-Center Planning Support
• ID Gain

The provided FDA 510(k) clearance letter and summary for MAGNETOM Free.Max and MAGNETOM Free.Star (K251822) offer high-level information regarding the devices and their comparison to predicate devices. However, it does not explicitly detail acceptance criteria (performance metrics with pass/fail thresholds) or a specific study proving the device meets those criteria for the overall device clearance.

The document primarily focuses on demonstrating substantial equivalence to predicate devices for general MR diagnostic imaging. The most detailed performance evaluation mentioned is for the AI feature "Deep Resolve Boost." Therefore, the response will focus on the information provided regarding Deep Resolve Boost, and address other points based on what is stated and what is not.

Acceptance Criteria and Device Performance (Focusing on Deep Resolve Boost)

Table 1. Deep Resolve Boost Performance Summary

Note: The document does not provide numerical thresholds or specific statistical methods used to define "significantly better" for SSIM and PSNR. The acceptance criteria are implicitly derived from the reported positive performance relative to conventional reconstruction.

Study Details for Deep Resolve Boost

1. Sample Size used for the test set and the data provenance:

   • Test Data: A "set of test data" was used for quantitative metrics (SSIM, PSNR) and visual evaluation. This test data was a "retrospectively undersampled copy of the test data" which was also used for conventional reconstruction.
   • Provenance: "In-house measurements and collaboration partners."
   • Retrospective/Prospective: The process of creating the test data by manipulating (undersampling) retrospectively acquired data indicates a retrospective approach.

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

   • Number of Experts: Not specified. The document states, "Visual evaluation was performed by qualified readers."
   • Qualifications of Experts: "Qualified readers." No further specific qualifications (e.g., years of experience, specialty) are provided.

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

   • Not specified. The document states, "Visual evaluation was performed by qualified readers." It does not mention whether multiple readers were used per case or how discrepancies were resolved.

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, an MRMC comparative effectiveness study involving human readers with vs. without AI assistance was not explicitly described for the Deep Resolve Boost feature. The visual evaluation was focused on comparing images reconstructed with conventional methods versus Deep Resolve Boost, primarily to assess image quality attributes without explicit human performance metrics (e.g., diagnostic accuracy, reading time).

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

   • Yes, a standalone performance evaluation was done. The quantitative metrics (SSIM, PSNR) and the visual assessment of images reconstructed solely by the algorithm (Deep Resolve Boost) were performed to characterize the network's impact independently.

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

   • The "acquired datasets represent the ground truth for the training and validation." Input data for testing was "retrospectively created from the ground truth by data manipulation and augmentation." This implies that the raw, fully sampled, and high-quality MRI acquisitions are considered the ground truth against which the reconstructed images (conventional and Deep Resolve Boost) are compared. This is a technical ground truth rather than a clinical ground truth like pathology.

7. The sample size for the training set:

   • TSE: More than 25,000 slices.
   • HASTE: Pretrained on the TSE dataset and refined with more than 10,000 HASTE slices.
   • EPI Diffusion: More than 1,000,000 slices.

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

   • "The acquired datasets represent the ground truth for the training and validation."
   • Input data for training was "retrospectively created from the ground truth by data manipulation and augmentation." This included "further under-sampling of the data by discarding k-space lines, lowering of the SNR level by addition of noise and mirroring of k-space data."
   • This indicates that the ground truth for training was derived from high-quality, fully sampled MRI acquisitions, which were then manipulated to simulate lower quality inputs for the AI to learn from.

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syngo.MR Applications is a syngo based post-acquisition image processing software for viewing, manipulating, evaluating, and analyzing MR, MR-PET, CT, PET, CT-PET images and MR spectra.

syngo.MR Applications is a software only Medical Device consisting post-processing applications/workflows used for viewing and evaluating the designated images provided by a MR diagnostic device. The post-processing applications/workflows are integrated with the hosting application syngo.via, that enables structured evaluation of the corresponding images

The provided FDA 510(k) clearance letter and summary for syngo.MR Applications (VB80) indicate that no clinical studies or bench testing were performed to establish new performance criteria or demonstrate meeting previously established acceptance criteria. The submission focuses on software changes and enhancements from a predicate device (syngo.MR Applications VB40).

Therefore, based solely on the provided document, I cannot create the requested tables and information because the document explicitly states:

• "No clinical studies were carried out for the product, all performance testing was conducted in a non-clinical fashion as part of verification and validation activities of the medical device."
• "No bench testing was required to be carried out for the product."

The document details the following regarding performance and acceptance:

• Non-clinical Performance Testing: "Non-clinical tests were conducted for the subject device during product development. The modifications described in this Premarket Notification were supported with verification and validation testing."
• Software Verification and Validation: "The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on the device Syngo.MR Applications during product development... The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence."
• Conclusion: "The predicate device was cleared based on non-clinical supportive information. The comparison of technological characteristics, device hazards, non-clinical performance data, and software validation data demonstrates that the subject device performs comparably to and is as safe and effective as the predicate device that is currently marketed for the same intended use."

This implies that the acceptance criteria are related to the functional specifications and performance of the software, as demonstrated by internal verification and validation activities, rather than a clinical performance study with specific quantitative metrics. The new component, "MR Prostate AI," is noted to be integrated without modification and had its own prior 510(k) clearance (K241770), suggesting its performance was established in that separate submission.

Without access to the actual verification and validation reports mentioned in the document, it's impossible to list precise acceptance criteria or detailed study results. The provided text only states that "all the software specifications have met the acceptance criteria."

Therefore, I can only provide an explanation of why the requested details cannot be extracted from this document:

Explanation Regarding Acceptance Criteria and Study Data:

The provided FDA 510(k) clearance letter and summary for syngo.MR Applications (VB80) explicitly state that no clinical studies or bench testing were performed for this submission. The device (syngo.MR Applications VB80) is presented as a new version of a predicate device (syngo.MR Applications VB40) with added features and enhancements, notably the integration of an existing AI algorithm, "Prostate MR AI VA10A (K241770)," which was cleared under a separate 510(k).

The basis for clearance is "non-clinical performance data" and "software validation data" demonstrating that the subject device performs comparably to and is as safe and effective as the predicate device. The document mentions that "all the software specifications have met the acceptance criteria" as part of the verification and validation (V&V) activities. However, the specific quantitative acceptance criteria, detailed performance metrics, sample sizes, ground truth establishment, or expert involvement for these V&V activities are not included in this public summary.

Therefore, the requested information cannot be precisely extracted from the provided text.

Summary of Information Available (and Not Available) from the Document:

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ACUSON Maple
The ACUSON Maple ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, Musculoskeletal, and Intraoperative applications using different ultrasound transducers for different applications. The system supports the Ultrasound-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

ACUSON Maple Select
The ACUSON Maple Select ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Vascular, Urology, Echocardiography, and Musculoskeletal applications using different ultrasound transducers for different applications. The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

The ACUSON Maple Diagnostic Ultrasound System and ACUSON Maple Select Diagnostic Ultrasound System are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Their function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image mode, Amplitude Doppler Mode, combination modes, Harmonic Imaging and 3D Imaging modes, or Harmonic Imaging and 4D imaging modes on a flat panel display for diagnostic ultrasound imaging.

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The ACUSON Juniper ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, Musculoskeletal, and Intraoperative applications using different ultrasound transducers for different applications.

The system supports the Ultrasound-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

ACUSON Juniper Select

The ACUSON Juniper Select ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Vascular, Urology, Echocardiography, and Musculoskeletal applications using different ultrasound transducers for different applications.

The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

The ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System are multi-purpose, mobile, software-controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Their function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image mode, Amplitude Doppler Mode, combination modes, Harmonic Imaging and 3D Imaging modes, or Harmonic Imaging and 4D imaging modes on a flat panel display for diagnostic ultrasound imaging.

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