(27 days)
The MAGNETOM system with the 6 Channel Body Coil is a whole body scanner. The MAGNETOM system with the 6 Channel Body Coil is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the MAGNETOM system with the 6 Channel Body Coil reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR properties that determine the image appearance are proton density; spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The MAGNETOM system with the 6 Channel Body Coil is a whole body scanner. The MAGNETOM system with the 6 Channel Body Coil is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. The images produced by the MAGNETOM system with the 6 Channel Body Coil reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The MR properties that determine the image appearance are proton density; spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
This document is a 510(k) summary for a 6 Channel Body Coil for MAGNETOM MR systems. It describes a device that is an accessory to an existing Magnetic Resonance imaging system, rather than an AI/ML powered device. As such, many of the requested categories are not applicable to the provided text.
Here's an analysis of the provided text based on the questions, with explanations for why some information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
For an accessory like an MRI coil, the "acceptance criteria" are typically demonstrating that the new component does not negatively impact existing safety and performance standards of the overall MR system, and that key imaging parameters are equivalent to or better than a predicate device.
| Acceptance Criteria (Stated as Unaffected or Equivalent) | Reported Device Performance (Reference to submission) |
|---|---|
| Safety Parameters: | |
| Maximum Static Field Strength | Unaffected by modifications |
| Rate of Change in Magnetic Field | Unaffected by modifications |
| RF Power deposition | Unaffected by modifications |
| Acoustic Noise Levels | Unaffected by modifications |
| Performance Parameters: | |
| Specification Volume | Unaffected by modifications |
| Signal to Noise (SNR) | Equivalent with predicate devices (Results presented in submission) |
| Image Uniformity | Equivalent with predicate devices (Results presented in submission) |
| Geometric distortion | Unaffected by modifications |
| High contrast spatial resolution | Unaffected by modifications |
| Slice profile, thickness and gap | Unaffected by modifications |
2. Sample size used for the test set and the data provenance
The document states "Laboratory and clinical testing were performed to support this claim of substantial equivalence," but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This is common for accessory 510(k)s where the focus is on hardware performance rather than clinical outcomes of a new diagnostic algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This document pertains to an MRI coil, a hardware accessory. The "ground truth" concept as applied to medical imaging interpretation (e.g., presence/absence of disease) is not relevant for this type of submission. The performance metrics are technical imaging parameters. The "trained physician" is mentioned in the "Indications for Use" as interpreting the images for diagnosis, but not in the context of establishing ground truth for the device's technical performance.
4. Adjudication method for the test set
Not Applicable. As the “ground truth” related to clinical interpretation or diagnosis is not part of the device's performance evaluation for this 510(k), no adjudication method for a test set of clinical cases is mentioned.
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 a hardware accessory (an MRI coil), not an AI/ML software device. Therefore, an MRMC study to compare human reader performance with and without AI assistance was not performed and is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a hardware accessory, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance characteristics (like SNR, Image Uniformity) would be physical measurements against established technical specifications and/or comparison to the predicate device's measured performance. It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
Not Applicable. This is a hardware accessory. There is no AI/ML model for which a "training set" would be used.
9. How the ground truth for the training set was established
Not Applicable. As there is no training set for an AI/ML model, this question is not relevant.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.