(49 days)
Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross sectional 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.
Your MAGNETOM system 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, MAGNETOM Skyra and MAGNETOM Prisma/ Prisma/ with software syngo MR XA30A, include new and modified hardware and software compared to the predicate device, MAGNETOM Vida with software syngo MR XA20A. A high-level summary of the new and modified hardware and software is provided below:
Hardware
- New Computer
Software
New Features and Applications
- SVS EDIT is a special variant of the SVS SE pulse sequence type, which acquires two different spectra (one with editing pulses on resonance, one with editing pulses off resonance) within a single sequence.
- BEAT_FQ_nav is a pulse sequence that allows the user to make use of navigator echo based respiratory gating for flow imaging to acquire 4D flow data. Both navigator echo based respiratory gating and flow imaging are cleared features available on the predicate device. However, the combination of the two is new.
- Injector coupling is a software application that allows the connection of certain contrast agent injectors to the MR system for simplified, synchronized contrast iniection and examination start.
- The Prostate Dot Engine provides an assisted and guided workflow for prostate imaging. This automated workflow leads to higher reproducibility of slice angulation and coverage based on the segmentation algorithm described and cleared with syngo.via VB40; this may support exams not having to be repeated.
Modified Features and Applications
- An optimized high bandwidth inversion recovery pulse is combined with gradient echo readout to improve diagnostic image quality when imaging myocardial tissue.
- The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol.
Other Modifications and / or Minor Changes
- Elastography-AddIn synchronizes settings between the Elastography sequence and the active driver.
- HASTE MoCo is an image-based motion correction function in the averagedimension for the HASTE pulse sequence type.
- Coil independent pulse sequences remove the coil information from the pulse sequences and generate this information during run-time from automatic coil detection and localization.
The provided document is a 510(k) summary for the Siemens MAGNETOM Aera, MAGNETOM Skyra, and MAGNETOM Prisma/Prismafit MR systems with syngo MR XA30A software. It details the device's substantial equivalence to a predicate device but does not describe specific acceptance criteria for a new feature's performance or a study demonstrating the device meets such criteria.
The document primarily focuses on demonstrating substantial equivalence by outlining:
- Device Description: New and modified hardware/software features (e.g., SVS EDIT, BEAT_FQ_nav, Injector coupling, Prostate Dot Engine, optimized high bandwidth inversion recovery pulse, AbsoluteShim mode, Elastography-AddIn, HASTE MoCo, Coil independent pulse sequences).
- Nonclinical Tests: These include "Sample clinical images," "Image quality assessments using sample clinical images," "Performance bench test," and "Software verification and validation." The results "demonstrate that the devices perform as intended and are therefore, substantially equivalent to the predicate device to which it has been compared."
- Clinical Tests/Publications: No clinical tests were conducted to support substantial equivalence for the subject devices. However, "sample clinical images were provided," and "clinical publications were referenced to provide information on the use of the following features and functions" (listing publications for SVS_EDIT and Prostate Dot Engine).
Therefore, I cannot extract the specific information requested because it is not present in the provided text. The document does not contain:
- A table of acceptance criteria and reported device performance.
- Details on sample sizes, data provenance, number of experts for ground truth, or adjudication methods for any specific test set.
- Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
- Details on the type of ground truth used for specific features.
- Training set sample size or how ground truth was established for a training set.
The document's purpose is to show that the new/modified features are substantially equivalent to existing ones and perform as intended through verification and validation activities, rather than presenting a performance study against predefined acceptance criteria for novel functionalities.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.