(87 days)
Magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) of adults and pediatrics of musculo-skeletal structures, soft tissue and vascular structures (mid-abdomen to mid-foot).
Model 675GE-64 Peripheral Vascular Coil consisting of Model 665GE-64 Lower Extremity Flexible Array and Model 538GE-64 Medium General Purpose Flex Coil. Compatible with GE Signa 1.5T MRI systems with Phased Array option.
The provided document is a 510(k) summary for a Magnetic Resonance Imaging (MRI) coil, not a medical device algorithm or AI-powered diagnostic tool. Therefore, many of the requested categories related to algorithm performance, training data, ground truth, and expert evaluation are not applicable.
The document describes the device's technical specifications and asserts its substantial equivalence to a predicate device based on safety and imaging performance parameters. The "acceptance criteria" here refer to meeting the established safety and imaging performance benchmarks of a legally marketed predicate device, rather than a diagnostic performance threshold for an AI model.
Here's a breakdown of the applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Parameter | Acceptance Criteria (based on predicate device) | Reported Device Performance |
|---|---|---|---|
| Safety Parameters | Maximum Static Magnetic Field | No change (compared to predicate device) | No change |
| Rate of Magnetic Field Strength Change | No change (compared to predicate device) | No change | |
| RF Power Deposition | No change (compared to predicate device) | No change | |
| Acoustic Noise Levels | No change (compared to predicate device) | No change | |
| Imaging Performance | Specification Volume | No change (compared to predicate device) | No change |
| Signal-to-Noise Ratio | No change (compared to predicate device) | No change | |
| Image Uniformity | No change (compared to predicate device) | No change | |
| Geometric Distortion | No change (compared to predicate device) | No change | |
| Slice Thickness and Gap | No change (compared to predicate device) | No change | |
| High Contrast Spatial Resolution | No change (compared to predicate device) | No change |
Study Proving Device Meets Acceptance Criteria:
The document states that the GE 1.5T Signa MRI system operated with the IGC-Medical Advances Peripheral Vascular Coil is substantially equivalent to the same system operated with the legally marketed predicate device. This statement implies that testing was conducted to verify that the new coil, when used with the specified MRI system, performs identically or equivalently to the predicate device with respect to the listed safety and imaging parameters. However, details of the specific "study" (e.g., experimental design, number of subjects, quantitative results) are not provided in this summary, as is typical for a 510(k) summary for a physical component like an MRI coil. The "study" here refers to the technical evaluation and comparison performed by the manufacturer to demonstrate substantial equivalence.
Regarding the unapplicable requested information (due to the device being an MRI coil, not an AI/algorithm):
- 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" of patient data in the context of an algorithm. Evaluation would involve technical measurements on phantoms and potentially studies on human volunteers/patients to confirm imaging quality, but the specifics are not detailed in this summary.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance of an algorithm is not relevant here.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's performance would be the direct physical measurements of its output (e.g., SNR, uniformity) and its adherence to safety limits.
- 8. The sample size for the training set: Not applicable. This device does not use a training set as it is not an algorithm.
- 9. 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.