Search Results

The MAGNETOM Aera and the MAGNETOM Skyra systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectro-scopic 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 Aera and the MAGNETOM Skyra systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.

MAGNETOM Aera (1.5 T) and MAGNETOM Skyra (3 T) are similar to the previously cleared MAGNETOM Espree and MAGNETOM Verio, utilizing a superconducting magnet design. The open bore, whole body scanners are designed for increased patient comfort. They focus on ergonomics and usability to reduce complexity of the MR workflow.

The MAGNETOM Aera and the MAGNETOM Skyra systems will be available in fixed and mobile configurations.

The Siemens MAGNETOM Aera and MAGNETOM Skyra systems are Magnetic Resonance Diagnostic Devices (MRDD). The study described in the provided documents did not involve a clinical study with human patients to establish acceptance criteria or device performance in the traditional sense (e.g., diagnostic accuracy, sensitivity, specificity).

Instead, the study's purpose was to demonstrate substantial equivalence to previously cleared predicate devices (MAGNETOM Espree and MAGNETOM Verio) by showing that the new systems conform to established safety and performance standards for MRDDs.

Here's a breakdown of the information based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the "Study" and Acceptance:

The "study" for these devices was a series of technical measurements and comparisons to demonstrate that the MAGNETOM Aera and Skyra meet internationally recognized standards for safety and that their performance is equivalent to that of the predicate devices. This type of testing is common for demonstrating substantial equivalence for medical devices that are refinements or updates to existing technology rather than entirely new diagnostic methods.

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

• Sample Size for Test Set: Not applicable in the context of human clinical data. The "test set" consisted of the MAGNETOM Aera and MAGNETOM Skyra devices themselves, subjected to various technical measurements and comparisons against established standards and predicate device performance.
• Data Provenance: The data provenance is from technical measurements performed on the devices according to NEMA, IEC, and ISO standards. It is not patient data from a specific country or collected retrospectively/prospectively.

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

• This is not applicable as the "ground truth" for this submission was based on established engineering and physics standards (IEC, ISO, NEMA) and the performance characteristics of predicate devices. There was no diagnostic "ground truth" derived from expert interpretation of images in a clinical study. The standards themselves represent a form of "expert consensus" in the engineering and medical device community.

4. Adjudication Method for the Test Set

• Not applicable for this type of technical performance and safety validation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. The submission is for an MRI system, not an AI-powered diagnostic tool, and it focuses on the safety and technical performance of the scanner itself.

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

• Not applicable. This device is an MRI system, which requires a human operator and physician interpretation. It is not an algorithm that operates standalone.

7. The Type of Ground Truth Used

• The "ground truth" for evaluating the devices was based on:
  • International Safety and Performance Standards: NEMA, IEC, and ISO standards for MRI devices.
  • Predicate Device Performance Data: Comparisons were made to the established performance of the legally marketed Siemens MAGNETOM Espree (1.5T) and MAGNETOM Verio (3T) systems.

8. The Sample Size for the Training Set

• Not applicable. This submission is for an MRI hardware system, not a machine learning algorithm that requires a training set of data.

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

• Not applicable as there was no training set for a machine learning algorithm.

Ask a specific question about this device

The MAGNETOM Systems with the syngo MR2006A are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

The "MAGNETOM Espree", the "MAGNETOM Avanto", the "MAGNETOM Symphony a Tim System", the "MAGNETOM Trio a Tim System" may also be used for imaging during interventional procedures performed with MR compatible instruments in room display and MR safe biopsy needles.

The MAGNETOM Systems with the syngo MR2006A are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities.

This document describes a 510(k) premarket notification for a software and hardware upgrade (syngo MR2006A) to existing Siemens MAGNETOM MRI systems. The primary claim is substantial equivalence to previously cleared devices.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, there are no specific quantitative acceptance criteria or reported device performance metrics listed in a table format. The submission focuses on demonstrating substantial equivalence by stating that the upgrade has "no significant effect on the MR safety and performance parameters" and that "the values are not significantly changed and, in the case of safety parameters remain below the level of concern."

The key "performance" claim is that the device will "conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices." However, no specific performance values against these standards are provided in the excerpt.

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

The document does not mention any specific test set sample size or data provenance (e.g., country of origin, retrospective or prospective) for proving the device meets acceptance criteria. The focus is on the upgrade's impact on existing, cleared MRI systems.

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

No information is provided regarding the number or qualifications of experts used to establish ground truth for a test set. This type of information would typically be present in studies evaluating diagnostic accuracy or clinical performance, which are not detailed in this submission.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned. Since there's no described test set involving human interpretation for ground truth establishment, adjudication methods are not applicable here.

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

No MRMC comparative effectiveness study is mentioned. The submission does not discuss human readers or improvements with AI assistance. The device is an MRI system software/hardware upgrade, not an AI-assisted diagnostic tool.

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

No standalone study demonstrating "algorithm only" performance is explicitly mentioned. The document states that the new software has "no significant effect on the MR safety and performance parameters" of the existing MRI systems. This implies that the upgrade itself was tested for its impact on the system's performance, but not as a standalone algorithm with a specific diagnostic output.

7. The Type of Ground Truth Used:

Given the nature of the submission (upgrade to an existing MRI system for substantial equivalence), the "ground truth" used for evaluation would primarily be derived from technical performance specifications and safety parameters as defined by NEMA and IEC standards for MRI devices. It's not a clinical ground truth like pathology or outcome data in the context of diagnostic accuracy. The key point is that the upgraded system continues to meet the established performance and safety characteristics of the predicate devices.

8. The Sample Size for the Training Set:

No training set sample size is mentioned. This type of information is typically relevant for machine learning or AI models, which are not the focus of this submission.

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

As no training set is mentioned, there is no information on how its ground truth was established.

Summary of Key Findings from the provided text:

• Acceptance Criteria/Performance: The primary acceptance criterion appears to be maintaining the safety and performance parameters of the predicate devices, conforming to NEMA and IEC standards, with "no significant effect" from the upgrade. Specific quantitative criteria and reported values are not provided in this excerpt.
• Study Design: The document describes an assessment for "substantial equivalence" of a software/hardware upgrade to existing MRI systems. It implies internal testing against established industry standards for performance and safety, rather than a clinical trial with a distinct test set or human readers.
• Lack of Detail: The provided text is a 510(k) summary focused on establishing substantial equivalence based on the minor nature of the changes. It does not contain the detailed study protocols, acceptance criteria tables, or performance metrics typically found in submissions for novel diagnostic devices or AI algorithms.

Ask a specific question about this device