(78 days)
The MAGNETOM Systems with the syngo MR 2002B are indicated for use as magnetic resonance diagnostic devices (MRDD's) 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 syngo MR 2002B (Numaris 4 VA21A) software upgrade will be available for the following MAGNETOM Family systems:
- The MAGNETOM 1.0 Tesla Harmony system
- The MAGNETOM 1.5 Tesla Symphony system
- The MAGNETOM 1.5 Tesla Sonata system
- The MAGNETOM 0.2 Tesla Concerto system
- The MAGNETOM 3.0 Tesla Allegra system
- The MAGNETOM 3.0 Tesla Trio system
This includes Siemens upgrades of currently used MAGNETOM Impact/Expert, Vision, and Open (Viva) systems to systems described above. Siemens Medical Solutions is adding an upgrade in software and hardware to the currently available MAGNETOM Systems. The MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications.
The provided text is a 510(k) Summary for the Siemens syngo MR 2002B software upgrade for MAGNETOM MRI systems. It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study proving a new device meets specific performance acceptance criteria.
Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present in this document. The document describes a software upgrade and asserts that the safety and performance parameters are not significantly changed from the predicate devices.
However, I can extract and infer some contextual information based on the document's content:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for new performance metrics or report specific performance values for the syngo MR 2002B. Instead, it states that the performance parameters of the device are not significantly changed compared to its predicate devices, implying that they meet the same implicit standards. The listed performance parameters examined are:
| Performance Parameter | Reported Device Performance (syngo MR 2002B) |
|---|---|
| Specification Volume | Not significantly changed (from predicate) |
| Signal to Noise | Not significantly changed (from predicate) |
| Image Uniformity | Not significantly changed (from predicate) |
| Geometric Distortion | Not significantly changed (from predicate) |
| Slice Profile, Thickness and Gap | Not significantly changed (from predicate) |
| High Contrast Spatial Resolution | Not significantly changed (from predicate) |
For safety parameters (Maximum Static Field, Rate of Change of Magnetic Field, RF Power Deposition, Acoustic Noise Level), the document states they "remain below the level of concern."
2. Sample size used for the test set and the data provenance
The document does not explicitly mention a specific "test set" or its sample size. It states that "Laboratory testing were performed to support this claim of substantial equivalence," but provides no details on the data used for these tests. Data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not describe the use of experts to establish ground truth for any specific test set. The nature of this submission (software upgrade for a diagnostic imaging device) suggests that the "ground truth" for evaluating image quality and safety would be established through technical specifications and physical measurements, and interpreted by qualified engineers and radiologists, but no details are provided.
4. Adjudication method for the test set
Not applicable, as no specific test set or adjudication process is described for establishing ground truth from experts.
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
No MRMC study is mentioned. This document pertains to an MRI system software upgrade, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document describes a diagnostic imaging device and its software upgrade, not an algorithm meant for standalone diagnostic performance. The device is intended to produce images and/or spectra "when interpreted by a trained physician yield information that may assist in diagnosis." Therefore, a standalone algorithm performance evaluation would not be applicable in this context.
7. The type of ground truth used
The ground truth implicitly used for validating the performance and safety of the MRI system would be based on physical phantom measurements and technical specifications compared against established engineering standards and regulatory limits for MRI devices. This is inferred from the listed "Performance" and "Safety" parameters that were evaluated, which are standard metrics for MRI scanner performance.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that would require a "training set" in the conventional sense. The "training" for the device's development would involve engineering and software development processes, not data-driven machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for an AI/ML model.
§ 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.