(59 days)
The MAGNETOM Trio system is a whole body scanner designed to support higher resolution imaging and shorter scan times. The Trio system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head and whole body. The images produced by the Trio system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin echo time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
The MAGNETOM Trio system is a whole body scanner designed to support higher resolution imaging and shorter scan times. The Trio system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures of the head and whole body. The images produced by the Trio system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin echo time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
Here's a breakdown of the acceptance criteria and the study information for the Siemens MAGNETOM Trio System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "safety parameters with action levels" and "performance levels" that were evaluated. It states that the "new levels are not significantly changed and, in the case of safety, parameters remain below the level of concern." However, specific numerical acceptance criteria (e.g., minimum SNR value, maximum geometric distortion percentage) and the exact reported device performance values are not provided in the given text.
| Acceptance Criteria Category | Specific Parameter | Acceptance Criteria (Not explicitly stated with numerical values) | Reported Device Performance (Not explicitly stated with numerical values) |
|---|---|---|---|
| Safety Parameters | Maximum Static Field | Below the level of concern (implied) | Not significantly changed from predicate, below level of concern |
| Rate of Change of Magnetic Field | Below the level of concern (implied) | Not significantly changed from predicate, below level of concern | |
| RF Power Deposition | Below the level of concern (implied) | Not significantly changed from predicate, below level of concern | |
| Acoustic Noise Levels | Below the level of concern (implied) | Not significantly changed from predicate, below level of concern | |
| Performance Levels | Specification Volume | Derived from FDA guidance (implied) | Not significantly changed from predicate |
| Signal to Noise | Derived from FDA guidance (implied) | Not significantly changed from predicate | |
| Image Uniformity | Derived from FDA guidance (implied) | Not significantly changed from predicate | |
| Geometric Distortion | Derived from FDA guidance (implied) | Not significantly changed from predicate | |
| Slice Profile, Thickness and Gap | Derived from FDA guidance (implied) | Not significantly changed from predicate | |
| High Contrast Spatial Resolution | Derived from FDA guidance (implied) | Not significantly changed from predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Laboratory testing were performed to support this claim of substantial equivalence," but it does not specify the sample size used for the test set.
- Sample Size (Test Set): Not specified.
- Data Provenance: The study was conducted as "Laboratory testing." The country of origin of the data is not specified, but the applicant is based in the US (Siemens Medical Systems, Inc., Iselin, N.J.). The study type is prospective laboratory testing, as it was performed to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The testing described appears to be technical performance testing against established FDA guidance parameters for MR diagnostic devices, rather than a clinical study requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The study described focuses on technical performance parameters of an MRI system, not on diagnostic accuracy based on expert adjudication of images.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not described in the provided text. The submission focuses on demonstrating substantial equivalence through technical performance evaluation against established guidance documents, not comparing human reader performance with and without AI assistance. The device is an MRI system, not an AI-powered diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in spirit, a standalone technical performance evaluation was done. The document states that "Laboratory testing were performed" to evaluate parameters like Signal to Noise, Image Uniformity, Geometric Distortion, etc. This testing assesses the inherent performance characteristics of the device itself, without necessarily involving human interpretation for diagnostic purposes, in the context of demonstrating substantial equivalence to predicate devices. The device described is a whole-body MRI scanner, and the "standalone" performance relates to its physical and technical capabilities as an imaging device.
7. The Type of Ground Truth Used
The "ground truth" for the technical performance parameters was established by FDA guidance documents for MR Diagnostic Devices. The document states that the safety and performance parameters "specified by the FDA guidance document for MR Diagnostic Devices were evaluated within this notification." This implies a comparison to acceptable ranges or thresholds defined by regulatory standards.
8. The Sample Size for the Training Set
This information is not applicable/provided. The device is an MRI system (hardware), not an AI algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the same reason as point 8.
§ 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.