(65 days)
Your MAGNETOM MR 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 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 inages 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.
Your MAGNETOM MR 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 Aera and MAGNETOM Skyra with syngo MR E11C Software is cleared with K153343. To address the Compressed Sensing Cardiac Cine and the modified Software Features described in this Premarket Notification Siemens intends to make the Software Application Package syngo MR E11C - AP02 available to the MAGNETOM Aera and Skyra.
The additional options for the synqo MR E11C software is being made available for the following MAGNETOM MR Systems:
- . MAGNETOM Aera,
- MAGNETOM Skyra .
The additional Options for the MR Scanner Software syngo MR E11C include a new feature with a new sequence and modified features for the above mentioned MR systems. A high level summary of sequences, features and improvements made available for the above systems is included below.
The provided text describes a 510(k) premarket notification for Siemens Medical Solutions USA, Inc.'s MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software. This document is a summary of the safety and effectiveness information supporting substantial equivalence to a predicate device.
However, the document specifically states: "No clinical tests were conducted to support the subject devices and the substantial equivalence argument; however, clinical images and LV evaluation were provided to support the argumentation and documentation which demonstrate the clinical utility and technical capabilities of the method."
This means that the information requested regarding acceptance criteria and a study proving the device meets these criteria (including details on sample size, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details) is not available in this document because a clinical study of this nature was not performed.
The substantial equivalence argument is based on non-clinical tests (image quality assessments, software verification and validation, and demonstrating similar technological characteristics to the predicate device) rather than a comparative clinical study.
Therefore, I cannot provide a detailed answer to your request based on the provided text, as the specific clinical study details you're asking for were explicitly stated as not having been conducted.
§ 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.