(58 days)
The MAGNETOM Verio is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays 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 and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Verio 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 Verio comes with I-class and T-class releases based on syngo MR B15B. It is a 3 Tesla MR scanner based on a superconducting magnet. It consists of the same types of hardware (with a modified magnet, gradient coil and RF body coil) that are currently available with the MAGNETOM Trio a Tim system including Matrix Coils and Total Imaging Matrix (Tim) technology.
The provided text describes the 510(k) summary for the Siemens MAGNETOM Verio, a magnetic resonance diagnostic device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria for performance against a clinical ground truth.
Therefore, many of the requested sections below cannot be fully populated as the information is not present in the provided document. The study described focuses on technical performance metrics (e.g., Signal-to-Noise Ratio, Geometric Distortion) to show equivalence to a predicate device, not on diagnostic accuracy based on a clinical ground truth.
Acceptance Criteria and Device Performance
The provided 510(k) summary does not present specific acceptance criteria in terms of clinical performance (e.g., sensitivity, specificity, accuracy) for a diagnostic task, nor does it report the device's performance against such criteria. Instead, it demonstrates substantial equivalence by comparing technical performance parameters to a predicate device.
The "acceptance criteria" can be inferred as showing comparable or better technical performance compared to the predicate device for various physical parameters.
| Acceptance Criteria (Implied) | Reported Device Performance (vs. Predicate) |
|---|---|
| Static Field Strength | Conforms to IEC, ISO, NEMA standards |
| Acoustic Noise | Conforms to IEC, ISO, NEMA standards |
| dB/dt | Conforms to IEC, ISO, NEMA standards |
| RF Heating | Conforms to IEC, ISO, NEMA standards |
| Biocompatibility | Conforms to IEC, ISO, NEMA standards |
| Signal-to-Noise Ratio | Performance shown to be equivalent |
| Geometric Distortion | Performance shown to be equivalent |
| Image Uniformity | Performance shown to be equivalent |
| Slice Thickness | Performance shown to be equivalent |
| Spatial Resolution | Performance shown to be equivalent |
Study Details
The provided document describes a technical study demonstrating substantial equivalence rather than a clinical study evaluating diagnostic performance.
-
Sample size used for the test set and the data provenance: Not applicable in the context of diagnostic accuracy. The performance measurements were done on the MAGNETOM Verio and the predicate MAGNETOM Trio a Tim System through technical evaluations. The specific sample sizes (e.g., number of scans, phantoms) used for each technical measurement are not detailed, nor is the "provenance" of such technical data mentioned beyond it being generated by the manufacturer.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here refers to established physical standards (IEC, ISO, NEMA) for safety and predefined measurements for performance. There were no human experts establishing a clinical ground truth for diagnostic purposes in this submission.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical adjudication process was described or required for these technical performance metrics.
-
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 submission is for an MRI scanner, not an AI-powered diagnostic algorithm. No MRMC study was mentioned.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a medical device (MRI scanner). The "performance" assessment was for the device's physical and imaging capabilities.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission was based on established engineering standards (IEC, ISO, NEMA) for safety parameters and direct physical measurements for performance parameters (e.g., SNR, geometric distortion) on the device and its predicate.
-
The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set. The device's design and manufacturing rely on established engineering principles and iterative development, not data-driven training in the AI sense.
-
How the ground truth for the training set was established: Not applicable. There was no "training set" or corresponding ground truth in the context of an AI/ML device.
§ 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.