Search Results
Found 1 results
510(k) Data Aggregation
(51 days)
GE 8CH FOOT ANKLE COIL
The GE 8CH Foot Ankle Coil is a receive-only RF surface coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The 8ch Foot Ankle Coil for GE 1.5T MRI systems is indicated for use for foot and ankle imaging. The nucleus excited is hydrogen.
The GE 8CH Foot Ankle Coil is a surface coil used for Magnetic Resonance Imaging. It's tuned to image Protor nuclei in a receive-only configuration. It is comprised of 8 individual Phased Array coil elements each utilizing an integrated preamplifier to improve image quality. The geometry is optimized for use with parallel imaging techniques.
The GE 8CH Foot Ankle Coil comprises the coil and the base plate. The coil conforms to patients' anatomy, accommodating various foot contours while minimizing patient discomfort. The base plate separated from the coil part is used to place the patients' anatomy on the table.
The GE 8CH Foot Ankle Coil is a receive-only RF surface coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The 8ch Foot Ankle Coil for GE 1.5T MRI systems is indicated for use for foot and ankle imaging. The nucleus excited is hydrogen.
The GE 8CH Foot Ankle Coil is 8-element phased array RF receive only coils with integrated preamplifiers. The coil designs consist of RF chokes with switching diodes to provide decoupling which isolates the coil elements from RF fields during RF transmission. This coil is designed based on the same technology as the predicate device.
The provided GE Healthcare 510(k) Premarket Notification Submission (K122694) details the substantial equivalence of the GE 8CH Foot Ankle Coil to a predicate device. This submission focuses on the safety and effectiveness of the coil itself, rather than the performance of an AI algorithm. Therefore, many of the requested details, such as AI model performance metrics (sensitivity, specificity, AUC), ground truth establishment for AI, sample sizes for test and training sets for AI, expert qualifications, and MRMC studies, are not applicable to this type of medical device submission.
The acceptance criteria and "study" described herein relate to the verification testing of the hardware device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Performed) | Reported Device Performance / Outcome |
|---|---|
| Biocompatibility Testing (Section 15) | Performed; documented in submission. |
| IEC 60601-1-2 testing (Section 17) | Performed; documented in submission. |
| Fulfilled (NRTL certification to UL 60601-1). | |
| IEC 60601-1 testing and NRTL certification to UL 60601-1 (Section 17) | Performed; documented in submission. |
| IEC60601-2-33 testing (Section 17) | Withstood maximum B1 peak fields and high B1 field energy concentrations without arcing or voltage breakdown; documented in submission. |
| Maximum B1 Peak test (Section 18) | Achieved according to NEMA standard; documented in submission. |
| Signal to Noise ratio and uniformity test (NEMA standard) (Section 18) | Effectiveness of blocking networks determined; ensured safety and minimized B1 distortion; documented in submission. |
| Blocking Network analysis (Section 18) | Passed under normal conditions; documented in submission. |
| Surface temperature test normal condition (Section 18) | Passed under unplugged conditions; documented in submission. |
| Surface temperature test unplugged condition (Section 18) | As safe, as effective, and performance substantially equivalent to the predicate device. |
| Clinical Image Review (Section 20) |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not discuss a "test set" in the context of an AI algorithm. Instead, it refers to "Sample clinical images" that were performed implicitly as part of the validation of the physical coil's performance.
- Sample Size: Not explicitly stated as a number of images or cases. The document mentions "Sample clinical images included in Section 20 Performance Testing - clinical."
- Data Provenance: The clinical images were "performed within GE Healthcare facilities." This implies a prospective or controlled retrospective acquisition within GE's own environment for verification purposes. The country of origin is not specified, but GE Healthcare has global operations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a hardware device submission, not an AI algorithm submission that requires expert-established ground truth for image interpretation. The verification tests are primarily engineering and safety-related.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a human-read interpretation or adjudication process for the clinical images in the context of establishing ground truth for an algorithm. The clinical images were used to demonstrate the qualitative performance of the coil.
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
Not applicable. This is a submission for an MRI coil, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. There is no AI algorithm involved in this submission.
7. The Type of Ground Truth Used
For the engineering and safety tests, the "ground truth" is defined by the technical standards (e.g., NEMA standards, IEC standards) and the physical properties and performance characteristics of the coil itself (e.g., signal-to-noise ratio, uniformity, temperature limits, B1 field tolerance). For the clinical images, the "ground truth" is the visual quality and diagnostic utility of the images produced by the coil, implicitly evaluated by GE's internal experts against established image quality criteria, though specific details of this evaluation are not provided in this summary.
8. The Sample Size for the Training Set
Not applicable. There is no AI algorithm or training set discussed in this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI algorithm or training set discussed in this submission.
Ask a specific question about this device
Page 1 of 1