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MAGNETOM Free.Max system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross-sectional images that display 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 vield information that may assist in diagnosis.

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

MAGNETOM Free.Star system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross-sectional images that display 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.

MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA60A include new and modified features compared to the predicate devices MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA50A (K220575, cleared on June 24, 2022).

Below is a high-level summary of the new and modified hardware and software features compared to the predicate devices MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA50A:

Hardware
New hardware features:

• Contour Knee coil
• Respiratory Sensor

Modified hardware features:

• myExam 3D Camera
• Host computer
• MaRS

Software
New Features and Applications:

• Injector coupling
• Respiratory Sensor Support
• myExam RT Assist (only for MAGNETOM Free.Max)
• myExam Autopilot Hip
• Deep Resolve Boost
• Complex Averaging
• HASTE_Interactive (only for MAGNETOM Free.Max)
• BEAT_Interactive (only for MAGNETOM Free.Max)
• Needle Intervention AddIn (only for MAGNETOM Free.Max)

Modified Features and Applications:

• Deep Resolve Sharp
• Deep Resolve Gain
• SMS Averaging

Other Modifications:

• Indications for Use (only for MAGNETOM Free.Max)
• MAGNETOM Free.Max RT Edition marketing bundle (only for MAGNETOM Free.Max)

The provided text describes information about the submission of the MAGNETOM Free.Max and MAGNETOM Free.Star MRI systems for FDA 510(k) clearance, and references a specific AI feature called "Deep Resolve Boost." However, it does not contain acceptance criteria or a detailed study proving the device meets specific performance criteria for the AI feature.

The section titled "Test statistics and test results" for Deep Resolve Boost (Table 1, page 7) mentions that the impact of the network was characterized by quality metrics such as PSNR and SSIM, and visual inspection. It also states: "After successful passing of the quality metrics tests, work-in-progress packages of the network were delivered and evaluated in clinical settings with cooperation partners." This suggests internal testing and evaluation, but does not provide the specific numerical acceptance criteria or the detailed results of these tests.

Therefore, I cannot fully complete the requested table and answer all questions due to the lack of this specific information in the provided document.

However, I can extract the available information regarding the AI feature "Deep Resolve Boost" as much as possible:

1. Table of acceptance criteria and the reported device performance:

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

• Test Set (Validation set for AI feature Deep Resolve Boost):
  • Sample Size: 1,874 2D slices.
  • Data Provenance: "in-house measurements and collaboration partners." The document does not specify the country of origin.
  • Retrospective or Prospective: Retrospectively created from ground truth by data manipulation and augmentation.

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

• Number of experts: Not specified.
• Qualifications of experts: The document states the "acquired datasets represent the ground truth for the training and validation," but it does not specify how this ground truth was established in terms of expert involvement for the test set. It mentions "clinical settings with cooperation partners" for evaluation, but this is distinct from ground truth establishment.

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

• Not specified. The document states "acquired datasets represent the ground truth," suggesting pre-existing data or a different method of ground truth establishment than explicit reader adjudication for this AI feature.

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

• The document states "No clinical tests were conducted to support substantial equivalence for the subject device" (page 10). It mentions that "work-in-progress packages of the network were delivered and evaluated in clinical settings with cooperation partners," but this is not described as an MRMC comparative effectiveness study, nor are any results on human reader improvement reported.

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

• The performance of the "Deep Resolve Boost" AI feature was characterized by "quality metrics such as peak signal-to-noise ratio (PSNR) and structural similarity index (SSIM)" and visual inspection, which suggests a standalone evaluation of the algorithm's output against a reference standard. Specific results are not provided.

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

• For Deep Resolve Boost: "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 implies that high-quality, likely clinical-grade, MRI scans acquired without the AI feature were considered the "ground truth" to which the AI-processed images were compared. It's not explicitly stated if this "ground truth" itself was established by expert consensus, but it infers it from high-quality clinical acquisition.

8. The sample size for the training set:

• For Deep Resolve Boost: 24,599 2D slices.

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

• "The acquired 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 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 "ground truth" was established by using full, high-quality MR images. The "input data" for the AI model (which the AI then "boosts") was intentionally degraded (under-sampled, noised) from this high-quality ground truth. The AI's task is to reconstruct the degraded input data back to resemble the original high-quality "ground truth."

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The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display 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 device software version, syngo MR XA50A, can support the following two MRI systems:

• MAGNETOM Free.Max, which has been cleared with its initial software version syngo MR XA40A, through K210611 on July 1, 2021;
• MAGNETOM Free.Star, a new product.

With the introduction of MAGNETOM Free.Star, we extend the Free. platform, which consists of two products with a field strength of 0.55 Tesla on our high-value MRI platform. The main difference between these two products is the bore size, MAGNETOM Free.Star is equipped with a 60 cm patient bore while the MAGNETOM Free.Max is equipped with an 80 cm patient bore. The Gradient system, body coil and the system cover for MAGNETOM Free.Star are modified based those of the predicate device MAGNETOM Free.Max with syngo MR XA40A (K210611) to accommodate the smaller bore diameter. The other main components for the new device MAGNETOM Free.Star are the same as those of MAGNETOM Free.Max as cleared with K210611.

Apart from the hardware adaption applied for MAGNETOM Free.Star for the smaller bore diameter, the new / modified hardware and software features for the subject devices comparing to the predicate device MAGNETOM Free.Max with software version syngo MR XA40A (K210611, cleared on July 1, 2021) are listed below:
MAGNETOM Free.Max software version syngo MR XA50A
New/Modified Hardware
Common for both subject devices:

• Scanner User Interface (SUI): introduce option to have two SUI set on both sides of the scanner, while there is only one set available on the left hand side as the standard configuration for the predicate device MAGNETOM Free.Max with software version syngo MR XA40A (K210611); Swap the orientation of patient pictogram on Select&GO is supported syngo MR XA50A.
• myExam 3D Camera: auto registration with detection of patient height. weight and orientation are supported in the subject device software version syngo MR XA50A. The hardware remains unchanged as cleared with K210611 on July 1, 2021.
• New Patient Video: A new patient video with 1920×1080 pixels is introduced.

Applicable to the following subject device(s)
MAGNETOM Free.Max
MAGNETOM Free.Star
New Local Coils
Contour M Coil
Contour M Coil
New Patient table – High-load patient table: a new fixed patient table with vertical movement for heavy load patient is introduced.
N/A

Software Features
Common for both subject devices:
New Software Platform/Workflow
myExam Autopilot is extended the supporting body region to shoulder:

• myExam Shoulder Autopilot: it helps users to automate a shoulder examination.
  Migrated Software feature
• EP2D FID: Single-shot FID EPI pulse sequence type optimized for perfusion-imaging in the brain.
• Inline Perfusion: Automatic real-time calculation of parameter maps with Inline technology based on image data acquired with the ep2d fid pulse sequence type.
• Access-i: Provides an interface to enable the connection of a 3rd party workstation to the MR syngo Acquisition Workplace via a network router and secure local network connection.

Modified Software Platform/Workflow
Modify in Scan assistance: Modified guidance of off-center imaging is provided to users who encounter the scan suspension by too off-centered shim volume.

The provided text is a 510(k) summary for the MAGNETOM Free.Max and MAGNETOM Free.Star with syngo MR XA50A. This document asserts substantial equivalence to a predicate device (MAGNETOM Free.Max with syngo MR XA40A) and does not describe specific acceptance criteria or a study designed to prove the device meets those criteria in detail as requested.

Instead, it states that:

• "The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate device to which it has been compared."
• "No clinical tests were conducted to support substantial equivalence for the subject device; however, as stated above, sample clinical images were provided."
• "The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device."

Therefore, it is not possible to provide the specific details requested in your prompt based solely on the provided text, as this document focuses on demonstrating substantial equivalence to a previously cleared device through non-clinical testing, rather than reporting on a study with detailed acceptance criteria for standalone performance or comparative effectiveness.

The document mentions non-clinical tests conducted, which include:

• Sample clinical images: To evaluate coils, new and modified software features, and pulse sequence types.
• Performance bench test: For SNR and image uniformity measurements for coils, and heating measurements for coils.
• Software verification and validation: Mainly for new and modified software features.

These tests were conducted in accordance with guidance documents like "Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" and "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

In summary, the provided document does not contain the specific information requested in your prompt regarding detailed acceptance criteria and a study proving the device meets them, sample sizes, expert qualifications, adjudication methods, or MRMC study results for human reader improvement. The document focuses on demonstrating substantial equivalence through non-clinical testing against established standards and predicate devices.

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The MAGNETOM MR system is indicated for use as a magnetic resonance diagnostic device (MRDD), which produces transverse, sagittal, coronal, and oblique cross sectional images that display 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 device, MAGNETOM Free.Max with software syngo MR XA40A, is an 80 cm bore Magnetic Resonance Imaging system with an actively shielded 0.55T superconducting magnet. Which is the first 0.55T MRI system for clinical use in the U.S.

This FDA 510(k) summary for the MAGNETOM Free.Max MRI system focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria for a new AI/CADe algorithm. Therefore, much of the requested information regarding AI performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not present in this document.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria in terms of numerical thresholds for specific performance metrics (e.g., sensitivity, specificity for a diagnostic task). Instead, the performance testing aims to demonstrate equivalence in image quality and safety to the predicate device.

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

• Test Set (for PNS study): 12 individuals
• Data Provenance: Not explicitly stated, but the PNS study was a "clinical study" suggesting prospective data collection. The software verification and validation would likely use a mix of internally generated and potentially simulated data. Sample clinical images would be from human subjects but their precise origin isn't detailed beyond being "sample clinical images."

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

• Not specified. The document does not describe the establishment of a "ground truth" by experts in the context of an algorithmic diagnostic performance study. The images are "interpreted by a trained physician" as per the Indications for Use, which is general clinical practice, not a specific ground truth establishment for algorithm evaluation.

4. Adjudication method for the test set

• Not applicable. No expert adjudication method is described for an algorithmic performance evaluation.

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

• No MRMC comparative effectiveness study involving human readers with and without AI assistance is mentioned. This submission is for the MRI system itself, not an AI-powered diagnostic aid that assists human readers.

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

• Not applicable. The "software verification and validation" would assess the software's functional performance, but not in the context of a standalone diagnostic algorithm providing a clinical output that would typically be evaluated for sensitivity/specificity. The Deep Resolve Gain and Deep Resolve Sharp features hint at image processing algorithms, but their standalone diagnostic performance is not presented.

7. The type of ground truth used

• For the PNS study, the "ground truth" would be the physiological response of the individuals.
• For image quality assessments, the ground truth is subjective visual assessment and objective metrics (SNR, uniformity) compared against engineering specifications and predicate device performance.
• For software verification and validation, the ground truth is adherence to design specifications and expected functional behavior.
• No "expert consensus, pathology, or outcomes data" ground truth is described in the context of validating a diagnostic algorithm's performance against clinical findings.

8. The sample size for the training set

• Not specified. The document refers to "Deep Resolve Gain" and "Deep Resolve Sharp" which are likely AI-based image processing features. However, the details of their training data (sample size, origin, ground truth) are not provided. The listed clinical publications for these features (e.g., "Residual Dense Network for Image Super-Resolution") suggest they are based on deep learning techniques that would require training data.

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

• Not specified. As noted above, details about training data for any potential AI components (like Deep Resolve) and their ground truth are not included in this summary.

Summary of what the document indicates about the device:

This 510(k) submission for the MAGNETOM Free.Max MRI system focuses on demonstrating substantial equivalence to an existing predicate device (MAGNETOM Sempra) by:

• Comparing technological characteristics (hardware and software).
• Performing non-clinical tests (sample clinical images, image quality assessments, bench tests for SNR/uniformity/heating, and general software V&V) to ensure the new device performs effectively and safely in a manner equivalent to the predicate.
• Conducting a small clinical study on Peripheral Nerve Stimulation (PNS) effects for safety.
• Referencing clinical publications for various new software features, implying that the underlying scientific principles and expected clinical utility of these features are generally accepted.

The document does not detail the validation of a specific AI/CADe diagnostic algorithm with acceptance criteria related to clinical diagnostic performance metrics. If "Deep Resolve Gain" and "Deep Resolve Sharp" involve AI, their validation is presented as part of overall system performance and image quality rather than as a standalone diagnostic aid.

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