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510(k) Data Aggregation
(75 days)
The TREX MRI system produces cross-sectional images:
- Anatomical Region: General body anatomy, including head, spine, forso, and extremities
- Nucleus excited: 1H nuclei (Proton)
- Diagnostic uses: Images correspond to the distribution of 1H nuclei exhibiting nuclear magnetic resonance, with image intensity dependent upon NMR parameters, including spin-lattice relaxation time (T1) spin-spin relaxation time (T2) density of nuclei (p) flow velocity chemical shift (δ)
- Clinical use: Images may be interpreted by a trained physician to yield information that can be useful in the determination of a diagnosis.
The TREX MRI 0.15T Elliptical MRI Magnetic Resonance Diagnostic Device is being enhanced by three additional RF Coils (Head Coil [quadrature], C-Spine Coil [quadrature], and Knee Coil [linear]) to increase the clinical utility of the TREX MRI in the stationary configuration.
The new quadrature Head Coil (Field Effects P/N 96530-01) will have a smaller diameter of 19 cm. The reduction in diameter will allow for improved coil fill factor, increasing SNR, while maintaining optimal coil uniformity. This new coil will replace the original Head Coil.
The new C-Spine Coil Field Effects P/N 96529-01) is substantially re-designed from the original coil, optimized for Cervical Spine imaging, and reducing the potential for patient anxiety and claustrophobia. This new coil utilizes a proprietary multiple receiver coil design, and will replace the original C-Spine/Knee Special Purpose Coil.
The new Knee Coil (Field Effects P/N 96629-01) utilizes a proprietary solenoid receiver coil design optimized for knee and extremity anatomies, improving coil fill factor, and increased S/N Ratio.
TREX MRI software did not need to be revised in order to support full functionality of these coils.
Below is a summary of the requested information based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Parameter | Acceptance Criteria (Specification) | Reported Device Performance (SNR) |
|---|---|---|
| Head Coil | ||
| ROI/Specification Volume | 15 cm dsv | > 34.2 |
| SNR | Not explicitly stated as acceptance criteria, but listed as specification volume for SNR. | < 14% |
| Uniformity | < 14% | < 2.5% |
| Geometric Distortion | < 2.5% | within 10% of nominally designated value |
| Slice Thickness | within 10% of nominally designated value | within 10% of nominally designated value |
| Slice Position | within 10% of nominally designated value | nominally equivalent to pixel size |
| Spatial Resolution | nominally equivalent to pixel size | |
| Body Coil | ||
| ROI/Specification Volume | 30 cm dsv | > 33.1 |
| SNR | Not explicitly stated as acceptance criteria, but listed as specification volume for SNR. | < 40% |
| Uniformity | < 40% | < 3.5% |
| Geometric Distortion | < 3.5% | within 10% of nominally designated value |
| Slice Thickness | within 10% of nominally designated value | within 10% of nominally designated value |
| Slice Position | within 10% of nominally designated value | nominally equivalent to pixel size |
| Spatial Resolution | nominally equivalent to pixel size |
Note: The provided text lists "Specification Volume" and then "SNR" with a numerical value. It appears the "SNR" values directly correspond to the performance for the specified volume. However, the text does not explicitly state the acceptance criteria for SNR in terms of a minimum target, but rather presents the achieved SNR as a performance metric for the given specification volume. For Uniformity, Geometric Distortion, Slice Thickness, Slice Position, and Spatial Resolution, the specification is the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The filing is for modifications to a Magnetic Resonance Diagnostic Device (TREX MRI) by adding new RF coils. The performance data presented refers to the specifications of these coils (SNR, Uniformity, etc.), not a clinical study involving a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. As mentioned above, the performance data relates to device specifications rather than clinical diagnostic accuracy evaluated against ground truth.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not provided in the document. The device described is a Magnetic Resonance Diagnostic Device (MRI scanner) with new RF coils, not an AI-powered diagnostic tool. Therefore, a MRMC study comparing human readers with and without AI assistance is not applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not provided in the document. As stated, this is a diagnostic imaging device (MRI) and not a standalone algorithm.
7. The Type of Ground Truth Used
This information is not provided in the document. The performance metrics presented (SNR, Uniformity, Geometric Distortion, Slice Thickness, Slice Position, Spatial Resolution) are technical specifications of the MRI coils themselves, derived from physical measurements and engineering evaluations, not from clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not provided in the document. This is a medical device submission for hardware modifications (RF coils), not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document. This is not applicable to the type of device and submission described.
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