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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
  • o Breast 18 (cleared with K133435 on December 12, 2013)
  • o Pediatric 16 (cleared with K140998 on July 11, 2014)
• 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:
  • Primary Predicate: MAGNETOM Spectra with syngo MR D12 (K121160)
  • Secondary Predicate: Siemens MAGNETOM Skyra with syngo MR E11A (K141977)
• 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.

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The MAGNETOM systems described above are 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.

The MAGNETOM systems described above 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 E11A for MAGNETOM Aera and MAGNETOM Skyra offers two new applications, LiverLab (an application of non-invasive liver evaluation) and MyoMaps (an application designed to provide a means to generate pixel maps for myocardial MR relaxation times). In addition, software syngo MR E11A makes the Dot Cockpit available for the user to modify and create Siemens Dot Engine workflows in a very intuitive way which supplements some of the support of an application specialist. The software syngo MR E11A also includes new and modified sequences as well as minor modifications of already existing features. In additional coils are offered and some hardware components have been modified.

Siemens Medical Solutions, USA Inc., intends to market MAGNETOM Aera and MAGNETOM Skyra with new software, syngo MR E11A. While syngo MR E11A offers additional capabilities with respect to the predicate device, the MAGNETOM Aera and MAGNETOM Skyra have the same technological characteristics as the predicate device (K121434; Cleared November, 5, 2012).

Furthermore, Siemens Medical Solutions, USA Inc., intends to market a new configuration of the MAGNETOM Skyra with 24 receive channels with software syngo MR E11A.

The MAGNETOM Aera and MAGNETOM Skyra will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Aera and MAGNETOM Skyra systems. The new MAGNETOM Skyra configuration with 24 receive channels will be offered as an ex-factory option (new production).

This FDA 510(k) summary describes a new software version (syngo MR E11A) for existing Siemens MAGNETOM Aera and MAGNETOM Skyra MRI systems. The primary focus of the document is to demonstrate substantial equivalence to previous versions and other cleared devices, rather than establishing new acceptance criteria for a novel device.

Therefore, the requested information regarding acceptance criteria, device performance, and specific study details (like sample size for test sets, expert qualifications, and adjudication methods) is largely not present for the overall system or its new features as this is an equivalence submission. The closest equivalent to "acceptance criteria" are the results of performance tests demonstrating the device performs as intended and is "substantially equivalent."

However, I can extract the available information regarding testing for the new features:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• MyoMaps Comparison Study:
  • Sample Size: 100 persons.
  • Data Provenance: Not specified, but involved "volunteers."
• LiverLab Validation:
  • Sample Size: Not specified beyond "volunteer" and "phantom scans."
  • Data Provenance: Not specified, beyond "volunteer" and "phantom scans" and "synthetic raw data."
• New Coils, Sequences, Algorithms, Acoustic Noise: Sample sizes not specified; phantom testing mentioned.
• Clinical tests (overall device): No clinical tests were conducted to support the substantial equivalence argument beyond the provision of clinical images to support new coils and software features.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the document. The document states that the images and spectra, "when interpreted by a trained physician, yield information that may assist in diagnosis." However, for validation studies, the specifics of expert involvement or ground truth establishment are not detailed.

4. Adjudication method for the test set

• This information is not provided in the document.

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

• A MRMC study comparing human readers with and without AI assistance was not mentioned or performed as part of this submission. The "MyoMaps" feature was compared to "Thalassaemia Tools," which is a comparison of two tools, not a human-AI comparison.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• The document describes "LiverLab" validation using "volunteer as well as phantom scans, and synthetic raw data" and "MyoMaps" being "tested on volunteers." This suggests standalone performance evaluation for these specific features. However, detailed metrics of standalone performance are not provided, only that the "results... demonstrate that the device performs as intended."

7. The type of ground truth used

• MyoMaps: The comparison was against "Thalassaemia Tools." For the "volunteers" testing, the method of establishing ground truth for myocardial MR relaxation times beyond direct measurement is not specified.
• LiverLab: Validation involved "volunteer as well as phantom scans, and synthetic raw data." The ground truth for phantom scans would be known parameters. For volunteer scans, the ground truth source for liver evaluation is not explicitly stated (e.g., biopsy results, clinical diagnosis).
• For other features (coils, sequences), the ground truth generally relies on physical measurements and expected image properties.

8. The sample size for the training set

• This information is not provided in the document. The submission focuses on verification and validation of implemented features rather than detailing the development or training of algorithms.

9. How the ground truth for the training set was established

• This information is not provided in the document. Given that details on a training set are absent, the method for establishing its ground truth is also not mentioned.

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