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