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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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Your MAGNETOM system is indicated for use as a magnetic 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 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 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 software syngo MR XA11A is similar to the previous cleared predicate device MAGNETOM Aera with syngo MR E11C (K153343) but includes new and modified hardware and software compared to MAGNETOM Aera. A high level summary of the hardware and software changes is included below.

The provided text describes the Siemens MAGNETOM Sola, a Magnetic Resonance Diagnostic Device (MRDD), and its journey through FDA clearance via a 510(k) premarket notification (K181322). The submission argues for substantial equivalence to a predicate device, MAGNETOM Aera (K153343). However, the document does not include a table of acceptance criteria or report device performance against specific metrics as requested. It outlines the scope of changes, safety testing, and refers to clinical images and a specific clinical study for nerve stimulation thresholds, but it doesn't detail performance-based acceptance criteria for image quality or diagnostic accuracy in the way typically seen for AI/ML devices.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is absent:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific reported device performance metrics against such criteria in the context of diagnostic accuracy or image quality improvements. The submission focuses on demonstrating substantial equivalence through:

• Similar intended use to the predicate device.
• Conformity to relevant standards (IEC, ISO, NEMA).
• Software verification and validation.
• Sample clinical images to support new/modified features.
• A clinical study to determine nerve stimulation thresholds for gradient system output.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set:
  • For the nerve stimulation thresholds study: 36 individuals.
  • For testing new/modified pulse sequences and algorithms, and supporting new coils/features: "Sample clinical images" were taken, but the exact number of cases or individuals is not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The text only mentions "Sample clinical images were taken" and "A clinical study... was conducted."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not specify the number or qualifications of experts used to establish ground truth for image quality assessments or the clinical images provided. The nerve stimulation study likely involved medical professionals, but their role in "ground truth" establishment for diagnostic purposes is not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for the test set.

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 multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The device is a Magnetic Resonance Diagnostic Device, not explicitly an AI/ML-driven diagnostic aid that would directly assist human readers in interpretation or diagnosis in the context typically seen in MRMC studies for AI.

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

The document describes the MAGNETOM Sola as a "magnetic resonance diagnostic device" which produces images and/or spectra that, "when interpreted by a trained physician, yield information that may assist in diagnosis." This indicates a human-in-the-loop system, implying that a standalone "algorithm only" performance study for direct diagnostic output was not the primary focus or perhaps applicable in the traditional sense for this device submission which is for the MR system itself rather than an AI-driven interpretation tool. However, the software verification and validation are for the algorithm within the system.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The type of ground truth used for image quality assessments or for the "sample clinical images" is not explicitly stated. For the nerve stimulation study, the "observed parameters were used to set the PNS (Peripheral Nerve Stimulation) threshold level," which seems to be a physiological measurement rather than a diagnostic ground truth.

8. The sample size for the training set

The document does not mention a training set sample size. This type of information is typically provided for AI/ML models that undergo specific training, which isn't the primary focus of this MRDD system clearance description.

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

Since a training set is not mentioned, the method for establishing its ground truth is also not provided.

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