(11 days)
The Medrad Phased Array Neurovascular coil is a receive-only coil intended to be used with the General Electric Superconducting MRI scanners. The coil will facilitate complete MR imaging of the intracranial/extracranial Neurovascular, skull base and C-Spine without moving the patient or the coil, i.e., no scan room intervention.
The Medrad 8-Receiver Phased Array Neurovascular Coil is a receive-only coil intended to be used with the General Electric Superconducting MRI scanners for MR imaging of the intracranial Neurovascular, skull base and C-Spine without moving the patient or the coil, i.e., no scan room intervention.
The provided text describes a Special 510(k) summary for a medical device called the "Medrad 8-Receiver Phased Array Neurovascular Coil." This submission focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive study with acceptance criteria and device performance metrics typical for novel AI/software devices. Therefore, much of the requested information regarding AI-specific criteria, sample sizes for test/training sets, expert involvement, and MRMC studies is not applicable or cannot be extracted from this document.
However, I can extract information related to the device's characteristics and the general approach to demonstrating its safety and effectiveness.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in the format typically seen for algorithms (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device. The performance is reported in terms of meeting design specifications and international standards, and having comparable features and functionality to the predicate.
| Feature / Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Proposed Device) |
|---|---|
| Coil type | Phased Array Receive-Only Coil (Same as predicate) |
| Region of Interest | Vertex of the skull to the aortic arch (Same as predicate) |
| Compatibility | All phased array GEMS 1.5T Signa Excite platforms with 8-Receiver capability; All Signa System pulse sequences and appropriate imaging options. (Similar, but updated compatibility for newer platforms/capabilities compared to predicate) |
| Tuning | No external tuning or matching necessary (Same as predicate) |
| System connection | Plugs into the MRI System by way of the Phased Array quick disconnect port (Same as predicate) |
| Imaging configurations | High resolution Head, Parallel imaging Fast Brain, Neurovascular, C-Spine (user optional), Volume Neck (user optional), High resolution Head and C-Spine (user optional) (Similar, with addition of "Parallel imaging" mention) |
| Housing Material | Polyurethane; Fire Rated UL 94V-0 (Similar to predicate's housing materials) |
| Comfort Pad Material | Cotton material embedded with urethane and is fire rated to CAL 117 (Same as predicate) |
| Safety and Effectiveness | Met design specifications, meets applicable requirements of international standards, risk analysis performed, design verification and validation testing conducted. |
2. Sample size used for the test set and the data provenance
This information is not applicable to this type of device submission. This is a hardware device (an MRI coil), not an AI/software product, and its evaluation focuses on engineering specifications, material compatibility, and functional equivalence, not on processing a "test set" of data for diagnostic performance. No data provenance is mentioned as there's no data analysis in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. There is no "ground truth" establishment in the context of an MRI coil's engineering and functional evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no "test set" or adjudication process described for this hardware device.
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, an MRMC comparative effectiveness study was not done. This device is an MRI coil, not an AI system. Therefore, there is no AI assistance to measure improvement for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is an MRI coil, a hardware component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The evaluation of this MRI coil focuses on adherence to engineering specifications, safety standards, and functional equivalence to a predicate device, rather than diagnostic accuracy against a clinical ground truth.
8. The sample size for the training set
This information is not applicable. This is a hardware device submission, not an AI/machine learning device that would involve a training set.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set mentioned, there is no ground truth establishment for it.
Summary of the Study for Substantial Equivalence:
The study proving the device meets the acceptance criteria (which, in this case, is primarily demonstrating substantial equivalence to a predicate device) is documented through the application of Medrad's design controls as part of its Quality System, compliant with FDA's Quality System Regulations (QSRs).
- Risk Analysis: A risk analysis was performed.
- Design Verification and Validation Testing: This testing was conducted to support the conclusions drawn from the risk analysis and to demonstrate that the device met its design specifications and applicable international standards. While specific test results are not detailed in this summary, the document states: "Test results demonstrate that the design specifications for the Medrad 8-Receiver Phased Array Neurovascular Coil were met and that the Medrad 8-Receiver Phased Array Neurovascular Coil meets the applicable requirements of the international standards cited."
- Comparison to Predicate Device: A detailed comparison of features and principles of operation to the legally marketed "Medrad 1.5T Phased Array Neurovascular Coil" (K984257) was provided. The comparison focuses on:
- Coil type
- Region of Interest
- Compatibility (with specific MRI scanners)
- Tuning
- System connection
- Imaging configurations
- Patient-contacting materials (housing and comfort pad)
The conclusion is that the proposed device is "substantially equivalent" to the predicate, maintaining the same intended use, similar operational parameters, similar labeling, and used in a similar manner.
§ 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.