(86 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/or spectra, and that displays the internal structure and/or function of the head, body, or extremittes. 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 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.
Software syngo MR XA12M is the latest software version for MAGNETOM Amira and MAGNETOM Sempra. It supports the existing "A Tim+Dot system" configuration for MAGNETOM Amira and MAGNETOM Sempra, and the newly introducted "A BioMatrix system" configuration for MAGNETOM Amira. Software version syngo MR XA12M for MAGNETOM Amira and MAGNETOM Sempra includes software applications migrated from the secondary predicate device MAGNETOM Sola with syngo MR XA11A (K181322). Only minor adaptations were needed to support the system specific hardware and optimize the sequences/protocols. In addition, new software features, Segmented TOF, HASTE with variable flip angle, SMS in RESOLVE and QDWI, are also introduced in syngo XA12M. The device also includes hardware updates such as new/modified coils and other components.
This document describes the 510(k) premarket notification for the Siemens MAGNETOM Amira and MAGNETOM Sempra Magnetic Resonance Diagnostic Devices (MRDD) with software syngo MR XA12M. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on adherence to recognized standards, verification and validation testing, and image quality assessments. The reported device performance is broadly presented as performing "as intended" and exhibiting an "equivalent safety and performance profile" to the predicate devices.
The table below summarizes the technological changes and the general assessment of their performance as described in the submission:
| Feature Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software Updates | Equivalent safety and performance to predicate software. Compliance with IEC 62304. | - New features (Segmented TOF, HASTE with variable flip angle, SMS in RESOLVE and QDWI) confirmed to perform as intended. |
| - Migrated features from K181322 (e.g., SliceAdjust, Compressed Sensing GRASP-VIBE, SPACE with CAIPIRINHA) included unchanged and function as intended. | ||
| - Functionality of modified features (e.g., Dixon fat/water separation, iPAT/TSE Reference Scan) maintained or improved. | ||
| Hardware Updates | Equivalent safety and performance to predicate hardware. | - New coils (ITX Extremity 18 Flare, BM Body 13) and modified hardware components (e.g., Magnet, Patient Table, Body Coil) confirmed to perform as intended. |
| Overall Device | Substantial equivalence to predicate devices, performing as intended with equivalent safety and performance profile. | - All features (software and hardware) verified and/or validated. |
| - Adherence to applicable FDA recognized and international IEC, ISO, and NEMA standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 14971, IEC 62366, IEC 62304, NEMA MS 6, NEMA MS 4, DICOM, ISO 10993-1). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" with a quantifiable sample size (e.g., number of patients or images). The evaluation relies on "sample clinical images" for the new coils and software features. The provenance of this data (e.g., country of origin, retrospective or prospective collection) is also not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for the "sample clinical images." The indication for use mentions that "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." This implies that the interpretation of images, including those used in performance testing, would be by a "trained physician," but no specific details are provided about the number or expertise of such individuals in the context of validating the device features.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the "sample clinical images" used in performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is mentioned. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing and adherence to standards, rather than evaluating the improvement of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The primary purpose of the device (MAGNETOM MR system) is to produce images, and the software features enhance image acquisition and processing. The performance testing described (image quality assessments, software verification and validation) evaluates the algorithm's output (images) in a standalone manner prior to a physician's interpretation. However, the device's indications for use inherently involve human interpretation ("when interpreted by a trained physician"). The document does not describe a purely "algorithm-only" performance assessment in the context of clinical decision-making, as the device's function is to aid diagnosis by a human.
7. The Type of Ground Truth Used
The type of ground truth for the "sample clinical images" is not explicitly stated. Given that no clinical trials were conducted, it's highly probable that qualitative "image quality assessments" were made by internal experts or against known phantom/in-vivo characteristics, and potentially compared to images from the predicate device. There is no mention of pathology, expert consensus (beyond general physician interpretation), or outcomes data being used as ground truth for this submission.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI algorithms. The changes are largely software and hardware updates, along with the integration of existing features from a predicate device. If any of the new features (e.g., Segmented ToF, HASTE with variable flip angle) involve learned components, the training set size and characteristics are not disclosed.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed or implied for machine learning, the method for establishing ground truth for a training set is not described. The software and hardware updates appear to be based on engineering development and optimization rather than machine learning model training.
§ 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.