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Your MAGNETOM 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 yield 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 displays and MR Safe biopsy needles.

MAGNETOM Sola with XJ gradient system is similar to the predicate device MAGNETOM Aera with syngo MR E11C (K153343) except for some new and modified software and hardware.

The provided text describes the Siemens MAGNETOM Sola MRI system and its substantial equivalence to a predicate device, but it does not contain specific acceptance criteria for a device's performance (e.g., accuracy, sensitivity, specificity) or a detailed study proving such criteria are met in the context of, for example, an AI/algorithm-based diagnostic aid.

The document mainly focuses on the regulatory submission for premarket notification (510(k)) of a new MRI system, detailing its hardware and software components, and asserting its safety and effectiveness based on equivalence to existing devices.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document.

However, I can provide the following based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance: Not available in the provided document in the context of a diagnostic performance study. The document primarily discusses performance in terms of achieving substantial equivalence for the overall MRI system, not specific diagnostic outcomes.

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

   • Sample Size: A clinical study of 40 individuals was conducted.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This study was specifically to determine nerve stimulation thresholds for the gradient system output, not for diagnostic image interpretation performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The clinical study mentioned was for nerve stimulation thresholds, not for establishing ground truth for diagnostic image interpretation.

4. Adjudication method for the test set: Not applicable based on the type of study mentioned (nerve stimulation thresholds).

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: No, an MRMC comparative effectiveness study is not mentioned. The device described is an MRI scanner, and the focus is on its hardware and software advancements for image acquisition and processing, not an AI-powered diagnostic interpretation tool for which such a study would typically be conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, standalone algorithm performance is not discussed. The device is a full MRI system, not a standalone algorithm.

7. The type of ground truth used: For the 40-individual study, the ground truth was the observed parameters related to nerve stimulation. It was used to set the Peripheral Nerve Stimulation (PNS) threshold level.

8. The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm's training set for diagnostic purposes. The software features described are part of the MRI system's operational software.

9. How the ground truth for the training set was established: Not applicable.

Summary of what is available from the document:

• The document is a 510(k) premarket notification for the Siemens MAGNETOM Sola MRI system.
• It describes new and modified hardware and software features compared to a predicate device.
• Nonclinical tests included:
  • Sample clinical images for coils.
  • Software verification and validation per FDA guidance.
  • Performance tests per FDA guidance for MRDDs.
  • Hardware modification verification & validation.
• Clinical tests involved a study of 40 individuals to determine nerve stimulation thresholds to limit gradient system output, which informed the PNS threshold level required by IEC 60601-2-33. No other clinical tests were conducted to support substantial equivalence for diagnostic performance, though sample clinical images were provided for new coils.
• The device is claimed to be substantially equivalent to the predicate device (MAGNETOM Aera with syngo MR E11C) based on having the same intended use and different technological characteristics that bear an equivalent safety and performance profile.
• The document lists various standards (IEC, ISO, NEMA) to which the device conforms for safety and performance, including software life cycle processes (IEC 62304:2006).

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