(84 days)
The Medrad Neurovascular Coil is a quadrature transmit/receive coil intended to be used MRI Scanner Systems for imaging of the brain, skull base, and soft tissues of the neck and upper chest, including the carotid arteries and attendant vascular system.
The Medrad 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 Neurovascular Coil is quadrature transmit / receive coil designed to enhance the MR Imaging of the head and neck anatomy.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medrad Neurovascular Coil:
This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific performance criteria against predefined numerical targets. The "acceptance criteria" are implied by the need to show performance that is at least equivalent to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for an MRI coil, the acceptance criteria are not explicitly stated as numerical thresholds for a new measurement or diagnostic claim. Instead, the "acceptance criteria" are implicitly met by demonstrating performance equivalent to the predicate devices in established MRI coil metrics.
| Performance Parameter | Implicit Acceptance Criteria (vs. Predicate) | Reported Device Performance |
|---|---|---|
| Signal-to-Noise Ratio (SNR) | SNR of the Medrad Neurovascular Coil should be comparable to or better than: |
- GE Head Coil (in head position)
- GE Anterior Neck Coil (in neck position) | A Signal-to-Noise Ratio (SNR) study was conducted to generate an SNR comparison between the proposed Medrad Neurovascular Coil and the predicate GE Head Coil (head position) and the GE Anterior Neck Coil (neck location). The conclusion states "increased SNR" which implies it met or exceeded the predicate. |
| Image Uniformity | Non-uniformity should be characterized and acceptable according to NEMA Standards. | The Medrad Neurovascular Coil was evaluated using NEMA Standards to characterize non-uniformity. Contours of images were constructed for axial, sagittal, and coronal views. (No explicit performance value given, but implied as acceptable). |
| Specific Absorption Rate (SAR) | SAR levels should be acceptable for different loading cases according to NEMA Standards and not exceed limits. | An SAR analysis was conducted per NEMA Standards for: - Lossless phantom (minimum load)
- Neck (heavy load)
- Head (light load). (No explicit values given, but implied as acceptable). |
| Geometric Distortion | No observable distortion of the static magnetic field should be present. | The device contains slightly magnetic materials, but they are positioned such that "no observable distortion of the static magnetic field is present." |
| Transmit RF Field [B1] Distortion | No significant currents induced; no artifacts observed during imaging. | Analysis of electrical design showed no significant currents induced. "No artifacts of any type were observed during imaging." |
| Clinical Evaluation (Morphological Detail) | Morphological detail should be equivalent to predicate devices. | Images obtained for the Medrad Neurovascular Coil were compared with the predicate GE Head Coil and GE Anterior Neck Coil. The results were compared "to substantiate equivalency with regards to morphological detail." The conclusion states "morphological detail" is achieved. |
| Clinical Evaluation (Image Clarity) | Image clarity should be equivalent to predicate devices. | Images obtained for the Medrad Neurovascular Coil were compared with the predicate GE Head Coil and GE Anterior Neck Coil. The conclusion states "image clarity" is achieved. |
| Safety and Durability | Device meets safety and durability standards. | "Extensive safety, verification, durability... testing was conducted." (Implied successful). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a numerical sample size for the "test set" (i.e., the number of patients or phantoms used for the SNR, SAR, image uniformity, and clinical evaluations).
- Data Provenance: The document does not explicitly state the country of origin. Given Medrad, Inc. is located in Indianola, PA, USA, it's highly probable the studies were conducted in the United States. The text states "Clinical Evaluation - Images were obtained..." and "A Signal to Noise Ratio(SNR) study was conducted...", implying these were prospective evaluations rather than retrospective data analysis. However, details are scarce.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The "Clinical Evaluation" section mentions "results were compared to substantiate equivalency with regards to morphological detail and SNR." This implies expert review, likely by radiologists, but no details are provided.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
The document does not describe any specific adjudication method for evaluating the clinical images. The comparison was qualitative to "substantiate equivalency with regards to morphological detail and SNR."
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
There is no mention of an MRMC comparative effectiveness study or any AI component in this submission. This device is an MRI coil, a hardware component, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is an MRI coil, not an algorithm.
7. The Type of Ground Truth Used
For the performance parameters, the "ground truth" is established through:
- Physical Measurements and Standards: For SNR, Image Uniformity (NEMA Standards), and SAR (NEMA Standards), the ground truth is derived from established physics principles and industry standards applied to physical phantoms or models.
- Visual Comparison with Predicate Device: For Geometric Distortion, Transmit RF Field [B1] Distortion, and Clinical Evaluation (morphological detail, image clarity), the "ground truth" or reference is the performance of the predicate GE Head Coil and GE Anterior Neck Coil. The goal is to show the new coil performs equivalently.
8. The Sample Size for the Training Set
This question is not applicable as the device is an MRI coil, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is an MRI coil, not an AI model.
Summary of the Study:
The study was primarily a comparative performance evaluation focusing on demonstrating substantial equivalence of the Medrad Neurovascular Coil to two predicate devices: the GE Head Coil and the GE Anterior Neck Coil.
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Key Tests Conducted:
- Signal-to-Noise Ratio (SNR) Study: Compared Medrad coil to GE Head Coil (head) and GE Anterior Neck Coil (neck).
- Image Uniformity: Evaluated using NEMA Standards.
- Specific Absorption Rate (SAR) Analysis: Conducted per NEMA Standards for various load cases (lossless phantom, neck, head).
- Geometric Distortion Analysis: Assessed for observable distortion.
- Transmit RF Field [B1] Distortion Analysis: Evaluated for induced currents and artifacts during imaging.
- Clinical Evaluation: Qualitative comparison of images obtained with the Medrad coil against predicate coils regarding morphological detail and SNR.
- Safety, Verification, Durability Testing: General statement of these tests being conducted.
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Conclusion: The studies aimed to show that the Medrad Neurovascular Coil is "substantially equivalent" to predicate devices, noting improvements like "increased SNR" and achieving "image clarity" and "morphological detail." The overall intent was to prove the device's safety and effectiveness for its intended use through comparison with already-marketed and accepted devices.
§ 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.