(89 days)
The MAGNETOM Harmony, Symphony, and Sonata System with the OR Table and Headholder is a whole body scanner. The MAGNETOM Systems with the OR Table and Headholder is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by MAGNETOM Systems with the OR Table and Headholder 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 relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The OR Table with headholder will be an option for intra-operative and interventional procedures.
The MAGNETOM Harmony, Symphony, and Sonata System with the OR Table and Headholder is a whole body scanner. The OR Table with headholder will be an option for intra-operative and interventional procedures. The MAGNETOM Harmony, Symphony, Sonata with the new OR Table and Headholder is substantially equivalent to the Neuro II system. Since we are simply adding an optional OR Table and headholder to the already existing MAGNETOM Harmony, Symphony, Sonata system, which will have exactly the same components (i.e. magnet, gradients, RF, and operating software). The optional OR Table and headholder will not have any significant effect on the currently available systems.
Here's an analysis of the provided text regarding the acceptance criteria and study details for the OR Table and Headholder for MAGNETOM Harmony, Symphony, Sonata:
Based on the provided 510(k) summary, this submission is for an accessory (OR Table and Headholder) to an existing Magnetic Resonance Imaging (MRI) system. The core of the acceptance criteria and study focuses on demonstrating that this new accessory does not negatively impact the safety and performance of the established MRI systems.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety | Maximum Static Field | No significant effect on this parameter. |
| Rate of Change of Magnetic Field | No significant effect on this parameter. | |
| RF Power Deposition | No significant effect on this parameter. | |
| Acoustic Noise Level | No significant effect on this parameter. | |
| Performance | Specification Volume | No significant effect on this parameter. |
| Signal to Noise | No significant effect on this parameter. | |
| Image Uniformity | No significant effect on this parameter. | |
| Geometric Distortion | No significant effect on this parameter. | |
| Slice Profile, Thickness and Gap | No significant effect on this parameter. | |
| High Contrast Spatial Resolution | No significant effect on this parameter. | |
| Overall Impact | No significant effect on currently available systems. | "Siemens did an evaluation on interference from the OR table which could affect the safety or effectiveness with the currently available systems." "Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a "test set" in the context of typical AI/software performance studies. This is because the submission is for a hardware accessory to an existing medical device, not a new algorithm or diagnostic system that evaluates patient data.
Instead, the "test set" would implicitly refer to the conditions and configurations under which the OR Table and Headholder were evaluated on the MAGNETOM systems. The provenance would be the test environment at Siemens. The document states:
- "Siemens did an evaluation on interference from the OR table which could affect the safety or effectiveness with the currently available systems."
- "Laboratory testing were performed to support this claim of substantial equivalence..."
This indicates prospective testing performed by Siemens to ensure the accessory's compatibility and lack of interference, rather than a dataset of patient images from a specific country or collected retrospectively.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The acceptance criteria relate to the physical and technical performance of the MRI system with the accessory, not to diagnostic interpretations requiring expert radiologists to establish ground truth on patient cases. The "ground truth" here is the established baseline performance of the MAGNETOM systems without the accessory.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are relevant for resolving discrepancies in expert interpretations of medical images or data. Since the study focuses on hardware compatibility and performance metrics of the MRI machine itself, such adjudication is not performed.
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 was no MRMC comparative effectiveness study done. This submission is for a hardware accessory (OR Table and Headholder), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant here.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
There was no standalone (algorithm only) performance study done. This is a hardware submission, not a software/algorithm submission.
7. The Type of Ground Truth Used
The "ground truth" used for this evaluation is the established and validated performance specifications and safety parameters of the existing MAGNETOM Harmony, Symphony, and Sonata MRI systems. The testing aimed to confirm that the addition of the OR Table and Headholder did not deviate these parameters outside of acceptable ranges. This is based on technical measurements and engineering standards, not clinical pathology, expert consensus on disease, or patient outcomes in the direct sense of a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" in the context of this 510(k) submission, as it's not for a machine learning or AI algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reasons as above.
§ 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.