(23 days)
The MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner. The MAGNETOM Open Viva with the Permanent magnet 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 OPEN with the permanent magnet 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 MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner.
This 510(k) submission describes a Magnetic Resonance Imaging (MRI) device, the Magnetom Open Viva with Permanent Magnet, and does not involve AI or algorithms. Therefore, many of the requested criteria, such as those related to AI algorithm performance, training sets, and expert adjudication, are not applicable.
Here's the relevant information based on the provided text:
Acceptance Criteria and Device Performance
The device is a medical imaging device (MRI) and its "performance" is assessed against established safety and technical specifications for MRI systems. The submission states that the modifications to this new model (a new permanent magnet) do not affect these critical safety and performance parameters.
| Acceptance Criteria (Safety Parameter with Action Levels & Performance Levels) | Reported Device Performance (Unaffected by Modifications) |
|---|---|
| Maximum Static Field | Unaffected |
| Rate of Change of Magnetic Field | Unaffected |
| RF Power Deposition | Unaffected |
| Acoustic Noise Levels | Unaffected |
| Specification Volume | Unaffected |
| Signal to Noise | Unaffected |
| Image Uniformity | Unaffected |
| Geometric Distortion | Unaffected |
| Slice Profile, Thickness and Gap | Unaffected |
| High Contrast Spatial Resolution | Unaffected |
Study Description for Substantial Equivalence
The study conducted was a laboratory testing to demonstrate "substantial equivalence" to a predicate device, the currently available MAGNETOM OPEN viva System. The purpose was to show that the technological differences (the new permanent magnet) do not raise any new questions pertaining to safety and effectiveness.
1. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The testing was laboratory-based, implying physical device measurements rather than patient data.
- Data Provenance: Not specified, but given it's laboratory testing of a device, it would be internal to the manufacturer's testing facilities. It's prospective testing of the manufactured device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This is not a study involving human interpretation of images for diagnosis or ground truth establishment. It's about direct measurement of the device's physical and imaging characteristics.
- Qualifications of Experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No human interpretation or adjudication of diagnostic findings was involved in this assessment for substantial equivalence.
4. 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 study is for a standalone MRI device, not an AI-assisted interpretation tool. Therefore, MRMC studies and effect sizes related to AI assistance are not applicable.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an algorithm. It's a medical imaging device. The "standalone" performance here refers to the device's physical and imaging capabilities.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth: The "ground truth" for this type of device evaluation is adherence to pre-defined engineering specifications, safety standards (e.g., those from the FDA guidance document for MR Diagnostic Devices), and performance metrics (e.g., Signal to Noise, Image Uniformity). These are objective, measurable parameters of the device itself.
7. The sample size for the training set:
- Not applicable. This is not an AI algorithm requiring a training set.
8. How the ground truth for the training set was established:
- Not applicable.
§ 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.