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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, and that display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images 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.

Disclaimer: Utility of contrast enhanced breast MRI for the detection of breast masses has not been documented and is thus not indicated.

The MAGNETOM C! system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times, which was described in premarket notification K043030 which received FDA clearance on December, 10, 2004. Siemens intends to modify the RF Infra Structure, RF Signal Unit, Filter Plate, Gradient Amplifier, Physiological Measurement Unit, Measurement and Reconstruction System, Magnet Temperature Unit, Patient Table Control, Power Distribution System, External Field Interference, Integrated Cooling System and software update for the existing MAGNETOM C! Magnetic Resonance System.

The provided text is a 510(k) summary for a Magnetic Resonance Diagnostic Device (MRDD) named MAGNETOM C!. This document is a submission for a modification to an already cleared device, and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against new, specific acceptance criteria through a clinical study.

Therefore, the text does not contain a detailed clinical study with acceptance criteria and reported device performance metrics in the way one might expect for a new, de novo device or a device claiming superiority. Instead, it relies on demonstrating that the modifications do not alter the fundamental safety and effectiveness, and that the device continues to conform to established standards for MRDDs.

Here's how to address the questions based on the provided text, highlighting where information is not available due to the nature of this 510(k) submission:

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

The document does not provide a table of acceptance criteria and reported device performance in the traditional sense of a clinical study. Instead, it lists performance levels that will be evaluated based on the modifications to ensure substantial equivalence:

The document states that the MAGNETOM C! "will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices." This implies that conformance to these standards serves as the acceptance criteria for the evaluated performance levels. However, it does not provide specific numerical performance results from a study within this text.

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

This information is not available in the provided text. The submission focuses on hardware and software modifications and their conformance to established standards for MR devices, rather than a clinical trial with a "test set" of patient data for diagnostic performance evaluation.

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)

This information is not available in the provided text. As there is no clinical study described with a "test set" requiring ground truth establishment, this detail is not relevant to this submission. The "trained physician" mentioned in the Indications for Use is a general statement about the interpretation of MR images, not specific to a study design.

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

This information is not available in the provided text as no clinical study with a test set is detailed.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of AI assistance. This device is an MRI system, not an AI-powered diagnostic tool as described in this submission.

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

This information is not applicable/not available. The MAGNETOM C! is a Magnetic Resonance Diagnostic Device (an MRI machine), not a standalone algorithm. Its performance is inherent in its ability to produce images for human interpretation.

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

This information is not available in the provided text as no clinical study requiring ground truth is detailed.

8. The sample size for the training set

This information is not available in the provided text. This submission does not describe a machine learning algorithm requiring a "training set."

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

This information is not available in the provided text. This submission does not describe a machine learning algorithm requiring a "training set" or ground truth for it.

Summary of the Study Proving Device Meets Acceptance Criteria (as per the provided text):

The "study" described in the 510(k) summary is not a traditional clinical trial with patient subjects and diagnostic outcomes. Instead, it is a demonstration of substantial equivalence for a modified medical device.

• Acceptance Criteria: The primary acceptance criterion for this submission is that the modified MAGNETOM C! system maintains its safety and effectiveness and continues to conform to existing recognized standards for Magnetic Resonance Diagnostic Devices (MRDDs) after the specified hardware and software modifications. Specifically, it must conform to:
  • FDA recognized NEMA Standards for the measurement of performance parameters (Signal to Noise, Image Uniformity, Geometric Distortion, High Contrast Spatial Resolution, Slice Thickness).
  • International IEC standard for safety issues with Magnetic Resonance Imaging Devices.
• Study Proving Acceptance: The manufacturer, Siemens Medical Solutions, Inc., asserts that the operation of the modified MAGNETOM C! System is substantially equivalent to the previously cleared MAGNETOM C! (K043030) and 1.5 T ESSENZA System (K071925). The "study" involves evaluating the specified performance levels (Signal to Noise, Image Uniformity, Geometric Distortion, High Contrast Spatial Resolution, and Slice Thickness) to ensure they meet the established NEMA standards. The document, however, does not provide the specific results or methodology of this evaluation within the text. It states that "the MAGNETOM C! will conform" to these standards, implying that internal testing or engineering assessments were conducted to verify this conformance.

In essence, this 510(k) submission relies on a comparison to predicate devices and adherence to established technical standards for MR systems, rather than a de novo clinical performance study against specific diagnostic acceptance criteria.

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