(82 days)
The MAGNETOM SYMPHONY with the High End Gradients is a whole body scanner with higher gradient amplitudes. The MAGNETOM SYMPHONY with the High End Gradients 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 the MAGNETOM SYMPHONY with the High End Gradients 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 (T") and flow. When interpreted by a trained by a trained physician, these images provide information that can be useful in determining a diagnosis.
The MAGNETOM SYMPHONY with the High End Gradients is a whole body scanner with higher gradient amplitudes.
The provided text describes a 510(k) submission for "High End Gradients" for the MAGNETOM SYMPHONY system, which is a Magnetic Resonance Diagnostic Device. This submission primarily focuses on demonstrating substantial equivalence to a predicate device and ensuring safety and effectiveness, rather than reporting on a study designed to meet specific diagnostic accuracy acceptance criteria.
The acceptance criteria mentioned are related to safety and performance parameters of the MR system itself, not the diagnostic accuracy of a specific AI algorithm. The study described is a laboratory testing to support the claim of substantial equivalence and ensure the technological differences do not raise new safety or effectiveness concerns.
Therefore, many of the requested elements (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not applicable or
available from this document because it's not an AI/algorithm performance study.
Here's an attempt to answer the questions based on the provided text, indicating where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists "safety parameters with action levels" and "performance levels" as evaluation criteria for the device (High End Gradients for MAGNETOM SYMPHONY). It explicitly states that "the new levels are not significantly changed and, in the case of safety, parameters remain below the level of concern as outlined by the FDA Guidance." However, the exact numerical acceptance criteria and reported performance values for each are not detailed in the provided text.
| Acceptance Criteria Category | Specific Parameter | Acceptance Criteria (Not explicitly stated numerically, but implied as "below level of concern" or "not significantly changed") | Reported Device Performance (Not explicitly stated numerically, but implied as meeting criteria) |
|---|---|---|---|
| Safety Parameters | Maximum Static Field | Below level of concern as outlined by FDA Guidance | Met |
| Rate of Change of Magnetic Field | Below level of concern as outlined by FDA Guidance | Met | |
| RF Power Deposition | Below level of concern as outlined by FDA Guidance | Met | |
| Acoustic Noise Levels | Below level of concern as outlined by FDA Guidance | Met | |
| Performance Levels | Specification Volume | Not significantly changed from predicate | Met |
| Signal to Noise | Not significantly changed from predicate | Met | |
| Image Uniformity | Not significantly changed from predicate | Met | |
| Geometric Distortion | Not significantly changed from predicate | Met | |
| Slice Profile, Thickness and Gap | Not significantly changed from predicate | Met | |
| High Contrast Spatial Resolution | Not significantly changed from predicate | Met |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "Laboratory testing were performed." It does not specify the sample size of any test sets (e.g., number of phantom scans, number of human subject scans) or the data provenance (e.g., country of origin, retrospective/prospective). This is a device modification submission, not a clinical study on diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The ground truth for this type of submission would relate to engineering measurements and adherence to technical specifications, not diagnostic interpretations by human experts in a clinical context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of diagnostic findings. Adjudication would likely be part of the internal engineering and testing processes by qualified personnel.
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. This document does not detail an MRMC study. It describes a change to the hardware of an MRI system (High End Gradients) and assesses its impact on the system's safety and performance, demonstrating substantial equivalence to a predicate device. It does not involve AI assistance or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This submission is for MRI hardware (gradients), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission would be defined by established engineering and physics principles, such as standardized phantom measurements, calibrated sensors for field strength, RF power, acoustic levels, and image quality metrics. It is not related to clinical diagnostic ground truths like pathology or expert consensus.
8. The sample size for the training set
Not applicable. This is not a submission for an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI/ML algorithm in this submission.
§ 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.