Search Results

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.

MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system includes new hardware compared to the predicate device, MAGNETOM Viato.Mobile with software syngo MR XA51A and XJ gradient system. A highlevel summary of the modified hardware is provided below:

Hardware
Modified Hardware

• Gradient Coil
• Gradient Power Amplifier

This document is a 510(k) summary for the MAGNETOM Viato.Mobile system from Siemens Medical Solutions USA, Inc. The submission is for a modification to an already cleared device, primarily involving new hardware (Gradient Coil and Gradient Power Amplifier) and an XQ gradient system option. This is a claim of substantial equivalence to an existing predicate device, not a new device requiring a full de novo study. Therefore, the information provided focuses on demonstrating that the modified device performs as safely and effectively as the predicate, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for diagnostic performance or a direct "reported device performance" in terms of clinical outcomes. Instead, it focuses on demonstrating that the modified hardware maintains the same safety and performance profile as the predicate device and reference device. The acceptance is based on compliance with standards and non-clinical testing.

2. Sample Size for the Test Set and Data Provenance

Since this is a submission for a hardware modification and claims substantial equivalence based on non-clinical testing and comparison to a predicate, there is no "test set" in the traditional sense of a patient cohort or imaging dataset used to assess diagnostic performance. The testing involved new hardware itself.

• Sample Size for Test Set: Not applicable in a clinical diagnostic performance sense. Non-clinical hardware tests were performed.
• Data Provenance: Not applicable for diagnostic performance.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. The ground truth for this submission concerns the performance and safety of the hardware modification, established through engineering tests and compliance with recognized standards. There were no experts establishing ground truth for diagnostic interpretations for this specific submission.

4. Adjudication Method

• Adjudication Method: Not applicable. There was no clinical ground truth requiring adjudication.

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

• MRMC Study: No. The document explicitly states: "No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device." This means there was no MRMC study to compare human readers with or without AI assistance, as the device itself is an MR scanner, not an AI-assisted diagnostic tool.

6. Standalone Performance Study

• Standalone Performance Study: No. This submission focuses on hardware safety and performance modifications of an MR scanner, not the standalone diagnostic performance of an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission is established through:

• Engineering test results and measurements: For performance bench tests, electrical safety, and electromagnetic compatibility.
• Compliance with recognized international standards: Like IEC 60601 series, ISO 14971, and NEMA MS 4:2010, which define safety and performance requirements for medical electrical equipment and MR systems.
• Comparison to the established safety and performance profile of the predicate and reference devices: The core argument is substantial equivalence, meaning the new hardware does not introduce new questions of safety or effectiveness compared to legally marketed devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI-driven image analysis algorithm that requires a training set of images. It is a hardware modification to an MR scanner.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI algorithm in this submission.

Ask a specific question about this device

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 vield 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.

MAGNETOM Viato.Mobile with software syngo MR XA51A includes minor modified hardware compared to the predicate device. MAGNETOM Sola Fit with software syngo MR XA51A. A high level summary of the modified hardware is provided below:

Hardware
Modified Hardware

• Cover
  Other Modifications and / or Minor Changes
• Adaptations for installation in a mobile trailer
• MAGNETOM Viato.Mobile is a mobile MR system which enables the customers to relocate the MRI system to different locations and therefore provide imaging services where it is needed.

The provided text describes the 510(k) summary for the MAGNETOM Viato.Mobile device, focusing on its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria and a study specifically proving the device meets those criteria for software-driven performance aspects, nor does it include information about AI/ML models.

The document states: "No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device." It primarily focuses on hardware modifications and compliance with general medical device standards.

Therefore, many of the requested details cannot be extracted from the provided text. Below is a summary of what can be inferred from the document and a clear indication of what information is missing.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in the context of an AI/ML model for diagnostic accuracy. Instead, the "performance" discussed relates to the device's adherence to general safety and operational standards as a Magnetic Resonance Diagnostic Device (MRDD).

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document regarding the device's overall functionality and safety):

Regarding the study that proves the device meets acceptance criteria:

The document explicitly states: "No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device."

The assessment for substantial equivalence was based on:

1. Bench testing of modified hardware: Performed according to "Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices."
2. Verification and validation (V&V) of modified hardware: Performed according to "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
3. Electrical safety and electromagnetic compatibility (EMC) testing of the complete system: Performed per IEC 60601-1-2.

The conclusion is that these non-clinical data demonstrate the device performs as intended and is substantially equivalent to the predicate device, the MAGNETOM Sola Fit (K221733).

Missing Information (Not found in the provided text):

1. Sample size used for the test set and the data provenance: Not applicable, as no performance study for diagnostic accuracy was conducted for an AI component. The tests were for hardware and system compliance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there was no test set requiring expert ground truth for diagnostic accuracy.
3. Adjudication method for the test set: Not applicable.
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: Not applicable. The device is a Magnetic Resonance Diagnostic Device, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

This device is primarily an MR hardware system with software for operation and image generation, not a device incorporating AI/ML for diagnostic interpretation. The substantial equivalence relies on proving the modified hardware and mobile integration retain the fundamental safety and performance characteristics of the predicate device, as demonstrated through engineering tests and adherence to recognized standards.

Ask a specific question about this device