(125 days)
The MAGNETOM Spectra 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 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 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.
The subject device, Software syngo MR E11M for the MAGNETOM Spectra, is the latest software version for the Siemens MR MAGNETOM Spectra. It is modified based on the software version syngo MR E11A, which was cleared with K141977 on November 19, 2014. The software functionality and applications are based on syngo MR E11A except in technical instances where adaptations were needed to support the system specific hardware and optimize the sequence/protocols. System tests validating the aforementioned adapations are provided in Appendix 9.
Listed below are the hardware updates to the MAGNETOM Spectra systems with software syngo MR E11M:
- · two new coils
- a modified MARS(Measurement and Reconstruction System) .
- an updated MRAWP/MRWP(Syngo Acquisition Workplace/ Syngo . Workplace) based on the new host platform
- . minor hardware changes to the transmit unit
The MAGNETOM Spectra with software version syngo MR E11M will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Spectra systems.
The provided text does NOT describe acceptance criteria for a device, nor does it detail a study that proves the device meets specific acceptance criteria in the way envisioned by the request.
Instead, this document is a 510(k) Premarket Notification from the FDA to Siemens Medical Solutions USA, Inc., concerning the MAGNETOM Spectra, a magnetic resonance diagnostic device. The purpose of a 510(k) submission is to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device, rather than to prove it meets specific performance acceptance criteria through clinical studies.
Here's an analysis based on the available information, highlighting what is and is not present:
Missing Information:
- Acceptance Criteria Table: The document does not provide a table of acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio targets).
- Reported Device Performance against Acceptance Criteria: Since no acceptance criteria are listed for diagnostic performance, there's no data reported against them. The document mentions nonclinical tests for SNR, image uniformity, and heating for new coils, and verification/validation for other software features, but doesn't provide specific numerical results or target values.
- Sample Size for Test Set and Data Provenance: No test set (clinical or otherwise for diagnostic efficacy) is described, so sample size, country of origin, or retrospective/prospective nature of data are not detailed.
- Number of Experts and Qualifications for Ground Truth: Not applicable, as there's no diagnostic performance study with ground truth establishment described.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or conducted.
- Standalone Performance Study: No standalone diagnostic performance study (algorithm only) is described. The device is an MRI system, not an AI algorithm.
- Type of Ground Truth Used: Not applicable for diagnostic performance as no such study is presented.
- Sample Size for Training Set: Not applicable, as this is an MRI system and software update, not an AI model trained on a dataset.
- How Ground Truth for Training Set was Established: Not applicable.
**Information that is available: **
The document focuses on demonstrating substantial equivalence to predicate devices for the MAGNETOM Spectra with software syngo MR E11M.
- Device Description: The MAGNETOM Spectra with software syngo MR E11M is described as the latest software version for the Siemens MR MAGNETOM Spectra, modified from syngo MR E11A. It includes two new coils (Breast 18 and Pediatric 16), a modified MARS (Measurement and Reconstruction System), an updated MRAWP/MRWP (Syngo Acquisition Workplace/Syngo Workplace) and minor hardware changes.
- Nonclinical Tests:
- The coils were tested for SNR (Signal-to-Noise Ratio), image uniformity, and heating.
- All other software features were verified and validated.
- The document states these tests "demonstrate that the device performs as intended." However, no specific quantitative results or acceptance thresholds are provided.
- Clinical Tests: "No clinical tests were conducted to support the subject device and the substantial equivalence argument, however clinical images were provided to support the new coils of the subject device." This explicitly states that no diagnostic clinical study was performed for this 510(k).
- Ground Truth (for New Coils): While not explicitly stated as "ground truth," the mention of "clinical images provided to support the new coils" implies that the performance of these coils was visually assessed by experts using clinical data, likely within internal validation processes, to ensure image quality was acceptable. However, the details of this assessment are not provided.
- Predicates:
- Regulatory Basis: The FDA's review concludes that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as the predicate, or if it has different technological characteristics, it does not raise new questions of safety or effectiveness.
In summary, the provided document is a regulatory clearance letter and 510(k) summary, not a study report detailing performance against specific acceptance criteria for diagnostic accuracy or efficacy. It relies on non-clinical testing and substantial equivalence to legally marketed predicates for device clearance.
§ 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.