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510(k) Data Aggregation
(74 days)
The Medrad Anterior Neck Coil is a receive only coil intended to be used with the General Electric Superconducting MRI Scanners. This coil is intended to facilitate complete MR imaging of the area superior to the oral pharynx and inferior to the brachial plexus. This area includes the pharynx, throat, tongue, larynx and thyroid regions anatomy.
The Medrad Anterior Neck Coil is a receive only coil intended to be used in MRI Scanner Systems for imaging of the area superior to the oral pharynx and inferior to the brachial plexus.
The Medrad Anterior Neck Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Magnetic Resonance Imaging.
The Medrad Anterior Neck Coil is a receive only coil designed to enhance the MR Imaging of the area superior to the oral pharynx and inferior to the brachial plexus. This area includes the pharynx, throat, tongue, larynx and thyroid regions.
The provided text describes a 510(k) submission for the Medrad Anterior Neck Coil, which is an MR Imaging Surface Coil. The submission focuses on demonstrating substantial equivalence to a predicate device, the General Electric (GE) Anterior Neck Coil, rather than presenting a study proving a specific performance claim against acceptance criteria for a new clinical indication.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a substantial equivalence submission, acceptance criteria are generally met by demonstrating that the new device is as safe and effective as the predicate device. The performance data primarily focuses on comparing physical and technical characteristics.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Medrad Anterior Neck Coil Performance (Comparison to Predicate) |
|---|---|
| Signal-to-Noise Ratio (SNR) equivalent to predicate device | A Signal-to-Noise Ratio (SNR) study was conducted to generate a Signal-To-Noise ratio comparison between the proposed Medrad Anterior Neck coil and the predicate GE Anterior Neck Coil. (No specific numerical values or acceptance thresholds are provided, but the conclusion implies performance is acceptable for substantial equivalence). |
| Image Uniformity acceptable/equivalent to predicate device | The Medrad Anterior Neck Coil was evaluated using NEMA Standards to characterize the non-uniformity of the proposed coil. Contours of the images obtained with the coil were constructed for the axial image and sagittal image. (No specific thresholds or quantitative results are provided, but the implied conclusion is positive). |
| No significant Geometric Distortion | None. "No observable distortion of the static magnetic field is present." |
| No significant Transmit RF Field B1 Distortion / artifacts | "No significant currents are induced. No artifacts of any type were observed during imaging." |
| Resolution, Slice Thickness, and Contrast unaffected by coil use | "Resolution, Slice Thickness, and Contrast - These performance parameters are not affected by the use of a surface coil and were not separately tested in the performance evaluation of the proposed Medrad Anterior Neck Coil." (This is a statement of expectation rather than a direct test result for the new device). |
| Clinical effectiveness similar to predicate device | Clinical images for the proposed 1.5T Anterior Neck Coil have been provided with this submission to demonstrate the clinical effectiveness of the Anterior Neck coils. Based on these results, and the SNR results for the 1.0T Anterior Neck Coil, Medrad concludes that the proposed 1.0T Anterior Neck Coil will produce similar clinical image results. |
| Patient contacting materials are safe and equivalent to predicate device | "All materials used are the same as the GE Anterior Neck coil. (Predicate device)." "Medrad, Inc. certifies that the patient contacting materials and formulations for the proposed Medrad Anterior Neck Coils are unchanged from currently marketed devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any test sets beyond stating "clinical images" were provided. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
No information is provided regarding the number or qualifications of experts used for any evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is described.
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 MRMC study was conducted. This device is an MRI coil, not an AI or software device. The focus is on the coil's physical and imaging characteristics.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical evaluation, the "clinical effectiveness" was demonstrated using "clinical images," implying that the visual assessment of these images by unspecified individuals, presumably radiologists or medical professionals, served as the basis for concluding their effectiveness. This is akin to expert opinion/visual assessment of image quality for diagnostic adequacy. For technical parameters like SNR, image uniformity, and geometric distortion, the ground truth would be quantitative measurements against established engineering standards (e.g., NEMA standards for uniformity).
8. The sample size for the training set
Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm.
Summary of the Study and Conclusion:
The "study" described is a technical comparison and performance evaluation for a 510(k) premarket notification. The core of the submission is to demonstrate that the Medrad Anterior Neck Coil is substantially equivalent to the predicate GE Anterior Neck Coil. The key finding is that Medrad was the original designer and manufacturer of the GE predicate device, and the proposed Medrad device is "exactly the same as the proposed device except for the labeling."
The performance data includes:
- Signal to Noise Ratio (SNR) study: Conducted to compare the proposed coil to the predicate.
- Image Uniformity evaluation: Using NEMA Standards.
- Geometric Distortion assessment: Concluding "none" due to careful placement of slightly magnetic materials.
- Transmit RF Field B1 Distortion analysis: Concluding "no significant currents are induced" and "no artifacts of any type."
- Resolution, Slice Thickness, and Contrast: Stated to be unaffected by the use of a surface coil and not re-tested.
- Clinical Evaluation: Clinical images were provided for the 1.5T coil to demonstrate effectiveness, with the conclusion that the 1.0T coil would produce similar results based on this and SNR data.
The overarching conclusion is that due to the device being essentially identical to the predicate (manufactured by the same company) and undergoing safety, verification, durability, and clinical testing as the predicate, the proposed device is substantially equivalent.
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