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The MAGNETOM systems, Avanto, Espree, Symphony A Tim System, Trio A Tim The Mr ONE Verio with software syngo MR B19, are indicated for use as magnetic oyoten, and volto many man one (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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, yield information that may assist in diagnosis.

The MAGNETOM systems, Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio with software syngo MR B19, may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.

Software syngo MR B19 is a new software version for five Siemens MR systems: MAGNETOM Avanto (1.5T), Espree (1.5T), Symphony A Tim System (1.5T), Trio A Tim System (3T), and Verio (3T). Systems that are already in clinical use and at customer sites (referred to as "field upgrades" throughout the rest of the submission) can be uparaded to this software version; some of the five MAGNETOM systems will be manufactured (referred to as "ex-factory systems" throughout the rest of this submission) with this software version (please see table below).

This new software version includes new software sequences, coils and other hardware for the five MAGNETOM systems. While some new features (hardware and software) are only available for certain systems (of the five listed), the basic syngo MR B19 software can run on each of the five MAGNETOM systems. Therefore, while five MAGNETOM systems are mentioned throughout this submission, the software version is the subject of this 510(k).

The Siemens Medical Solutions USA, Inc. 510(k) submission for "Software syngo MR B19 for MAGNETOM Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio" provides information about device performance validation, but does not include acceptance criteria as a table, nor does it detail a study proving the device meets specific acceptance criteria in the manner typically associated with clinical performance studies for AI/CAD devices.

This submission is for a software upgrade (syngo MR B19) to existing Magnetic Resonance Diagnostic Devices (MRDDs). The focus of the submission is on demonstrating substantial equivalence to previously cleared predicate devices (syngo MR B17 and syngo MR D13A), rather than proving net new clinical performance characteristics through comparative studies against quantitative acceptance thresholds.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

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

• Not present in the form requested. The submission focuses on demonstrating substantial equivalence by comparing the new software's features and performance to existing predicate devices. It states:
  • "The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate devices to which it has been compared."
  • "Performance testing such as SNR, image uniformity, and heating were conducted on the subject device. Additionally, all software features were verified and validated."
  • The new features "do not introduce any new issues of safety or effectiveness."
  • The document implies that the "acceptance criteria" are the standards of performance (SNR, uniformity, heating) met by the predicate devices, and the new software meets or exceeds these. However, no specific numerical thresholds or a table like:

...is provided.

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

• Not explicitly detailed in the provided text for "test sets" in a clinical performance sense. The document states:
  • "There were not any clinical tests conducted to support the subject device and the substantial equivalence argument, however clinical images are provided to support the new coils as well as the new and modified software features of the subject device."
  • This indicates that while some clinical images were "provided," a formal clinical study with a defined test set sample size and provenance (like retrospective/prospective, country of origin) was not performed for this 510(k) submission. The performance testing mentioned (SNR, uniformity, heating) would involve phantom or controlled tests, not necessarily human subject data.

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)

• Not applicable / Not present. Since no formal clinical performance test set (as would be used for AI/CAD) was conducted or presented in this submission, there is no mention of experts establishing ground truth for such a set. The "trained physician" mentioned in the Indications for Use refers to the end-users of the device for diagnosis, not experts establishing ground truth for a study.

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

• Not applicable / Not present. No clinical test set requiring adjudication was performed as part of this submission.

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 (Not for this submission). This is a submission for a general MR system software update, not specifically for an AI/CAD product. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted or presented.

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

• Not applicable. The device is an MR diagnostic device software, which always operates with human interpretation ("when interpreted by a trained physician"). It is not a standalone algorithm providing diagnostic outputs without human involvement. The "performance testing" on SNR, uniformity, etc., can be considered an "algorithm only" or device-only performance assessment, but not in the context of diagnostic accuracy.

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

• No external ground truth for clinical diagnostic performance was established for the purpose of this submission. The device's performance was validated against engineering and technical standards (e.g., SNR, image uniformity, heating) and its equivalence to predicate devices was the primary argument.

8. The sample size for the training set

• Not applicable / Not present. This submission does not describe a machine learning algorithm or AI model that requires a training set. It's a software upgrade for an imaging system.

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

• Not applicable / Not present. As there's no mention of an AI/ML training set, there's no discussion of establishing ground truth for one.

Summary of Device Performance and Acceptance Criteria (as implied by the document):

The acceptance criteria for this software upgrade are implicitly tied to maintaining or improving the recognized performance characteristics (e.g., SNR, image uniformity, heating) and safety of the predicate MR systems, and ensuring the new features integrate without introducing new safety or effectiveness concerns. The study described is non-clinical performance testing and verification/validation of software features, rather than a clinical performance study with defined ground truth and statistical endpoints against clinical acceptance criteria. The "proof" is the demonstration of substantial equivalence through these engineering performance tests and the claim that the device performs "as intended" and "does not introduce any new issues of safety or effectiveness."

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