(56 days)
The Medrad Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy.
The Medrad Phased Array Neurovascular Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.
The Medrad Phased Array Neurovascular Coil is a receive only, phased array coil designed to enhance the MR Imaging of the head and neck anatomy.
The provided text describes a 510(k) premarket notification for a medical device, the Medrad 1.5T Phased Array Neurovascular Coil. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical performance studies typical for novel devices.
Therefore, many of the requested categories regarding acceptance criteria, sample sizes, expert ground truth, and AI performance studies are not applicable or explicitly mentioned in detail in this document. The submission primarily addresses technical comparisons and basic performance characteristics relevant to an MRI coil.
Here's the breakdown of available information based on your request:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in the way one might expect for a new diagnostic algorithm (e.g., a specific sensitivity or specificity threshold). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The performance tests conducted aim to show that the new coil's performance is comparable to or better than the predicate in key areas relevant to MRI coils.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Signal-to-Noise Ratio (SNR) | Conducted: "A Signal to Noise Ratio(SNR) study was conducted to generate a Signal -To-Noise ratio of the proposed Medrad 1.5T PHASED ARRAY NEUROVASCULAR Coil and the predicate Neurovascular device." (No specific numerical results are provided in this summary, but the study was performed presumably to show comparable or improved SNR). |
| Image Uniformity | Evaluated: "The Medrad PHASED ARRAY NEUROVASCULAR coil was evaluated using NEMA Standards to characterize the uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image, sagittal image and coronal images." (No specific numerical results are provided, but evaluation using NEMA standards implies meeting accepted uniformity characteristics). |
| Geometric Distortion | Observed: "None. Static magnetic field distortion results from the use of magnetic materials in the construction of a surface coil. This device contains slightly magnetic materials or components. However, such components have been positioned within the surface coil so that no observable distortion of the static magnetic field is present." |
| Transmit RF Field [B1] Distortion | Demonstrated (by analysis): "Analysis of the electrical design of the coil and its blocking network demonstrates that no significant currents are induced. No artifacts of any type were observed during imaging." |
| Clinical Effectiveness | Provided: "Clinical images for the proposed 1.5T PHASED ARRAY NEUROVASCULAR have been provided with this submission to demonstrate the clinical effectiveness of the PHASED ARRAY Neurovascular." (No detailed study description or quantitative results are included in this summary). |
| Substantial Equivalence | Concluded: "The proposed device is deemed by Medrad to be substantially equivalent." (FDA concurred with this conclusion). |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The "Clinical images" were provided, but the number of cases or subjects is not mentioned.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not mentioned. The study involves demonstrating technical performance characteristics of an MRI coil and clinical effectiveness through imaging, not a diagnostic decision validated by experts in the context of classification or detection. Clinical effectiveness is demonstrated by the quality of the clinical images themselves.
4. Adjudication method for the test set
- Not applicable/Not mentioned. This is not a study requiring adjudication of diagnostic outcomes.
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 device is an MRI coil, not an AI-powered diagnostic algorithm.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is hardware (an MRI coil), not an algorithm.
7. The type of ground truth used
- For technical performance criteria like SNR, image uniformity, and geometric distortion, the "ground truth" is established through physical measurements and NEMA standards.
- For "Clinical Evaluation," the ground truth is implicitly the quality and diagnostic utility of the images produced by the coil, observed by qualified personnel (though not explicitly detailed as expert consensus in this summary).
8. The sample size for the training set
- Not applicable. This is hardware, not an AI model requiring a training set.
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.