(76 days)
The Medrad Breast 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 breast anatomy.
The Medrad Breast Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the breast anatomy.
The Medrad Breast Coil is intended for use only under the supervision of a physician who is trained in the field of Diagnostic Resonance Imaging.
The Medrad Breast Coil is a receive only coil designed to enhance the MR lmaging of the breast anatomy. This coil is designed to be used optimally with either a conventional Signa 1.5T system, or a system including the Phased Array upgrade.
Here's an analysis of the provided text regarding the Medrad Breast Coil, focusing on acceptance criteria and the supporting study:
The provided document, a 510(k) summary (K982921), describes a medical device, the Medrad Breast Coil, and its comparison to a predicate device for regulatory clearance. It does not contain a typical "acceptance criteria" table with specific thresholds for performance metrics. Instead, the "acceptance criteria" appear to be implicit in demonstrating substantial equivalence to a legally marketed predicate device (GE Breast Coil) by showing that the new device performs as well as or better than the predicate, or that any differences do not raise new questions of safety or effectiveness.
The "study" conducted to "prove the device meets the acceptance criteria" is primarily a technical comparison and performance evaluation against the predicate device, rather than a standalone clinical trial with pre-defined success metrics.
Here's the information broken down:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Conclusion: The proposed device is deemed substantially equivalent to the predicate GE Breast Coil (K923025). "Mechanically and electrically the devices are identical. This labeling change is the only change to the device." |
| Signal-to-Noise Ratio (SNR) Comparable to Predicate | SNR Study Conducted: A Signal to Noise Ratio (SNR) study was conducted to generate a comparison between the proposed Medrad Breast coil and the predicate GE Breast Coil. The summary implies the results were favorable or at least non-inferior to support substantial equivalence. (Specific numerical results are not provided in this summary.) |
| Image Uniformity Acceptable per NEMA Standards | Evaluated using NEMA Standards: The Medrad Breast Coil was evaluated using NEMA Standards to characterize the non-uniformity of the proposed coil. Contours of the images obtained were constructed for axial and sagittal views. (Specific results or acceptance thresholds are not provided, but the conclusion implies satisfactory uniformity.) |
| No Geometric Distortion | Geometric Distortion: "None." The device contains slightly magnetic materials, but they are positioned "so that no observable distortion of the static magnetic field is present." |
| No Transmit RF Field [B1] Distortion / No Artifacts | Transmit RF Field [B1] Distortion: Analysis of electrical design and blocking network demonstrates "no significant currents are induced." "No artifacts of any type were observed during imaging." |
| Preservation of Resolution, Slice Thickness, and Contrast | 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 Breast Coil." (This is an assertion based on the coil type, rather than a direct measurement that met a criterion). |
| Clinical Effectiveness Demonstrated | Clinical Evaluation: "Clinical images for the proposed 1.5T Breast Coil have been provided with this submission to demonstrate the clinical effectiveness of the breast coils." Based on these, and SNR for .5T/1.0T coils, Medrad concludes that the .5T/1.0T coils will produce "similar clinical image results." (Specific clinical metrics are not provided). |
| Patient-Contacting Materials are Safe and Identical to Predicate | Material Comparison: "All materials used are the same as the GE Breast coil (Predicate device)." Medrad certifies materials for the proposed device are "unchanged from currently marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for any of the performance tests (SNR, Image Uniformity, Clinical Evaluation).
- Data Provenance: Not explicitly stated (e.g., country of origin). The document describes general performance evaluations and clinical images. It doesn't specify if these were from a particular study population or retrospective/prospective collection. Given the context of a 510(k) summary for a component (coil), this evaluation would likely be conducted in a controlled environment (e.g., lab, imaging facility) rather than a broad clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This type of detail is not provided in the 510(k) summary. The evaluation focuses on technical performance and image characteristics rather than interpretation-based "ground truth" established by experts for a diagnostic output. The "clinical images" were provided to "demonstrate clinical effectiveness," implying review by qualified personnel, but details are absent.
4. Adjudication Method for the Test Set
- Not applicable as the evaluation described is primarily technical performance testing and image characteristic assessment, not diagnosis or interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. The document describes technical evaluations and a submission of "clinical images" to demonstrate effectiveness, but not a study comparing human readers with and without AI assistance, or comparing human reader performance using different coils in an MRMC design.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is an MRI breast coil, which is a hardware component. It does not involve an algorithm or AI that would have "standalone" performance in the sense of a software-as-a-medical-device (SaMD). Its performance is directly tied to the image acquisition process.
7. The Type of Ground Truth Used
- The term "ground truth" in the diagnostic sense (e.g., pathology, outcomes) is not applicable here. The "truth" for the performance tests would be the established engineering and imaging physics standards (e.g., NEMA standards for image uniformity, physical measurements for distortion, electrical design analysis). For the "clinical images," their "effectiveness" would be judged by their ability to clearly depict breast anatomy, which is a qualitative assessment by imaging professionals.
8. The Sample Size for the Training Set
- Not applicable. The Medrad Breast Coil is a hardware device (receive-only coil) and does not involve AI/machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set is involved for this hardware device.
§ 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.