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510(k) Data Aggregation
(71 days)
The Medrad Quad C-Spine 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 sella turcica and inferior to the third thoracic vertabrae. Included is the brachial plexus region, nerve roots and CSF.
The Medrad Quad C-Spine Coil is a receive only coil intended to be used MRI Scanner Systems for imaging of the Area superior to the top of the sella turcica and inferior to the third thoracic vertebra
The Medrad Quad C-Spine 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 Quad C-Spine Coil is a receive only coil designed to enhance the MR lmaging of the area superior to the top of the sella turcica and inferior to the third thoracic vertabrae. Included is the brachial plexus region, nerve roots and CSF.
Receive-only Quadrature coil.
The Quad C-Spine coil is compatible with all GE Signa System pulse sequences and appropriate imaging options.
No external tuning, or matching, is necessary since the coil is matched to the recommended anatomy of interest.
The coil plugs into a common slip connector.
The housing material is made from Royalite ABS, Fire Rated UL 94V-0
Comfort pad material is made of Unifoam S82N, Fire Rated UL 94 HF-1 with a PVC Film vinyl film fire rated cover.
Here's an analysis of the provided text regarding the Medrad Quad C-Spine Coils, focusing on acceptance criteria and supporting studies:
This submission details a medical device, the Medrad Quad C-Spine Coil, which is an enhancement (a receive-only coil) for existing Magnetic Resonance Imaging (MRI) systems. The core of this 510(k) summary is to demonstrate substantial equivalence to predicate devices, rather than proving efficacy from first principles. Therefore, the "acceptance criteria" and "study" described are primarily focused on showing that the new device performs comparably to or better than existing, legally marketed coils.
1. Table of Acceptance Criteria and Reported Device Performance
Because this is a 510(k) submission for a device component (an MR coil) that enhances existing systems, the "acceptance criteria" are implied by a comparison to predicate devices, particularly in performance parameters relevant to image quality and safety. There isn't a single, explicit table of acceptance criteria with numerical targets in the provided text. Instead, the performance is evaluated relative to the predicate devices.
| Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (Medrad Quad C-Spine Coil) |
|---|---|
| Similar Signal to Noise Ratio (SNR) compared to predicate devices. | A Signal to Noise Ratio (SNR) study was conducted to generate a comparison between the proposed Medrad Quad C-Spine coil and the predicate Hitachi Quad C-Spine (K954952) and the General Electric Linear C-Spine (K884369). (Explicit results of this comparison are not provided in this summary, but the study was performed implying favorable or equivalent results for substantial equivalence.) |
| Acceptable Image Uniformity (relative to NEMA standards and predicate experience). | Evaluated using NEMA Standards to characterize non-uniformity. Contours of the axial and sagittal images were constructed. (Explicit results of this evaluation are not provided, but the method was applied.) |
| No observable Geometric Distortion. | None. Device contains slightly magnetic materials, but positioned so "no observable distortion of the static magnetic field is present." |
| No 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. |
| Resolution, Slice Thickness, and Contrast unaffected. | These parameters are "not affected by the use of a surface coil and were not separately tested." |
| Demonstrated safety (e.g., material biocompatibility, electrical safety). | Patient contacting materials are identical to predicate devices: Royalite ABS (housing), Unifoam S82N with PVC Film (comfort pad), all fire rated. "Extensive safety, verification, durability and clinical testing was conducted on the predicate devices." Implies the new device, being substantially equivalent in design and materials, shares this safety profile. |
| Clinical image quality comparable to predicate devices. | "Clinical Evaluation - Images were obtained for the proposed Medrad Shoulder Coil. The clinical images of the predicate devices may be found in their respective 510(k) submissions." (Implied positive outcome for substantial equivalence.) |
Study Proving Device Meets Criteria:
The primary study conducted is a comparative performance evaluation against two predicate devices: the GE Linear C-Spine Coil (K884369) and the Hitachi Quad C-Spine Coil (K954952). The goal is to demonstrate "substantial equivalence" to these legally marketed devices, rather than showing de novo efficacy.
2. Sample Size Used for the Test Set and Data Provenance
The text does not explicitly state the sample size used for the test set in the SNR study, image uniformity and distortion tests, or the clinical evaluation.
- Data Provenance: The studies were conducted by Medrad, Inc. in the context of a 510(k) submission to the US FDA. The source of the data is internal testing and evaluation. The nature of these tests (e.g., phantom studies for SNR, uniformity, distortion; clinical imaging of volunteers/patients) implies prospective data collection specifically for this regulatory submission. Country of origin for the data is implicitly the United States, given the company's location and FDA submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts used to establish ground truth.
- For technical parameters like SNR, uniformity, and distortion, ground truth is typically established through quantitative measurements using phantoms and standardized protocols (e.g., NEMA standards) rather than expert human interpretation in the same way clinical diagnostic studies might.
- For the "Clinical Evaluation," while images were obtained, the ground truth for "images of the proposed Medrad Shoulder Coil" would be the direct images themselves. If a comparison was made for diagnostic quality, this would typically involve radiologists. However, this level of detail is not provided. The phrase "The clinical images of the predicate devices may be found in their respective 510(k) submissions" suggests a qualitative comparison rather than a formal, blinded, multi-reader study with independent ground truth.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Given the technical nature of much of the testing (SNR, uniformity, distortion) and the lack of explicit detail on the "Clinical Evaluation," formal adjudication (like 2+1 or 3+1 consensus) is unlikely to have been a component of these specific tests as 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, an MRMC comparative effectiveness study was not done.
- This device is an MR coil, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable. The goal is to produce high-quality MR images for human readers to interpret, not to assist those readers with AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm-only) performance study was not done.
- Again, this is a physical medical device (an MR coil), not a software algorithm. Its "performance" is in its ability to acquire high-quality images, which are then interpreted by a human (the radiologist).
7. The Type of Ground Truth Used
- For SNR, Image Uniformity, and Geometric Distortion: Ground truth is established through quantitative physical measurements using phantoms and NEMA standards.
- For Resolution, Slice Thickness, and Contrast: The statement that these are "not affected by the use of a surface coil" implies that the fundamental physics of MRI and the system's capabilities (which are part of the predicate device's established performance) form the basis of this 'ground truth'.
- For the Clinical Evaluation: The "clinical images" themselves serve as the primary data. While not explicitly stated, "ground truth" for diagnostic quality in such a comparison would implicitly rely on expert radiologist interpretation of the images, comparing them to those obtained with predicate devices, likely in a qualitative or semi-quantitative manner. There is no mention of pathology or outcomes data being used as ground truth for the coil's performance.
8. The Sample Size for the Training Set
- The concept of a "training set" is not applicable to this device. This is a physical, passive receive coil, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no training set for this type of device.
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