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The MAGNETOM C! is indicated for use as magnetic resonance diagnostic devices (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. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM C! 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 MAGNETOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times, which is was described in premarket notification K041111 which received FDA clearance on July 16, 2004. Siemens further market the Body spine XL coil, Wrist Array coil with 4 channels, Cordless Coil, Breast Array coil, Breast biopsy device, MR guided procedure Package, In Room MRC, Foot switch and the software update for the existing MAGNETOM C! MR system.

The provided text describes the acceptance criteria for the MAGNETOM C! MR System and the study used to demonstrate its substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria in the context of an AI/algorithm-driven device.

Here's a breakdown of the requested information based on the provided text, and where the information requested for AI-related studies is not applicable or not present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size for test set: Not applicable/not specified. The provided text describes a submission for substantial equivalence based on established performance parameters for an MRI system, not an algorithm's performance on a specific test set of cases.
• Data provenance: Not applicable/not specified. This is a submission for an entire MRI device, not an AI algorithm.

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

• Not applicable. Ground truth for an AI algorithm's performance is not relevant to this type of device submission. The device produces images "when interpreted by a trained physician yield information that may assist in diagnosis."

4. Adjudication method for the test set

• Not applicable.

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

• Not applicable. This is not an AI-assisted device.

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

• Not applicable. This is a medical imaging device, not a standalone algorithm.

7. The type of ground truth used

• Not applicable in the context of an AI algorithm's performance validation. For the MRI system itself, the ground truth relates to its physical performance parameters (Signal to Noise, Image Uniformity) as measured against NEMA and IEC standards, which represent established engineering and safety benchmarks for device functionality.

8. The sample size for the training set

• Not applicable. There is no AI algorithm being described as part of this submission.

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

• Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The study described is an assessment of substantial equivalence for the MAGNETOM C! MR system, which is an upgrade to an existing system, including new coils and software updates. It's not a study validating an AI algorithm's performance.

The "acceptance criteria" for this device are its performance levels (Signal to Noise, Image Uniformity) and safety compliance. The study demonstrates that the device will conform to established industry and international standards.

• Criteria:

  • Signal to Noise
  • Image Uniformity
  • Compliance with safety requirements

• Methodology: The submission asserts that the MAGNETOM C! will conform to:

  • FDA recognized NEMA Standards for the measurement of performance and safety parameters (specifically for Signal to Noise and Image Uniformity).
  • International IEC standard for safety issues with Magnetic Resonance Imaging Devices.

• Conclusion: By demonstrating conformity to these recognized standards, Siemens believes the device can be considered safe and effective and is substantially equivalent to the predicate devices (Siemens MAGNETOM 0.2 T Concerto, Siemens MAGNETOM 1.0 T Harmony, and Siemens MAGNETOM 0.35 T C!). This approach assures that the performance of the device meets the necessary safety and effectiveness requirements.

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