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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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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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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.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission outlines performance levels that the MAGNETOM C! system will conform to, largely by referencing NEMA and IEC standards for established MRI safety and performance parameters. It states that the device "will conform" to these standards, implying that meeting these standards serves as the acceptance criteria. However, explicit numerical performance metrics for the MAGNETOM C! are not provided in the summary. Instead, it relies on substantial equivalence to predicate devices (MAGNETOM 0.2 T Concerto and MAGNETOM 1.0 T Harmony) that presumably already meet these standards.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not describe a specific clinical test set or data provenance for the MAGNETOM C! device. The submission relies on demonstrating substantial equivalence to existing cleared devices (Siemens MAGNETOM 0.2 T Concerto and Siemens MAGNETOM 1.0 T Harmony) by stating that its operation is "substantially equivalent" and that it "will conform" to established industry standards (NEMA and IEC) for safety and performance. This implies that the standards themselves (NEMA and IEC) are the basis for evaluation, not a new clinical study with a specific patient dataset.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Since no specific clinical test set data is described, there is no information provided regarding experts used to establish ground truth. The evaluation is based on technical specifications and conformance to industry standards, not on human interpretation of specific images from a test set.

4. Adjudication Method for the Test Set

As there is no described clinical test set for the MAGNETOM C! in this submission, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned or described in the provided text. The submission focuses on technical performance and substantial equivalence, not on comparing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The MAGNETOM C! is a diagnostic device (MRI scanner), not an AI algorithm. Therefore, a standalone study for an algorithm's performance is not applicable and not included in this submission. The device itself is the "algorithm" in a sense, as it generates the images, but its performance is measured by its output quality and safety parameters, not by its diagnostic interpretation independent of a human.

7. Type of Ground Truth Used

The "ground truth" in this context is implicitly the established safety and performance metrics defined by FDA-recognized NEMA Standards and international IEC standards for MRI devices. The device's performance is assessed against these technical and safety specifications rather than against clinical outcomes, pathology, or expert consensus on specific patient cases.

8. Sample Size for the Training Set

As this is a submission for an MRI device and not an AI algorithm, the concept of a "training set" in the context of machine learning does not apply to the information provided. The development and testing of an MRI scanner involve engineering and physics principles, not a data-driven training approach.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" as understood in AI/ML, this question is not applicable to the provided information.

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