Search Results

The DuoFLEX Coil Suite is indicate for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to product 2D and 3D images. The DuoFLEX Coil Suite is for use with GE Healthcare MR Systems.

The MR Instruments FC1500G-8R DuoFLEX® Coil Suite includes three different sets of coil paddles and a single, shared preamplifier box (the "Connector Box") with a system connector. One set of coil paddles is a pair of 24cm square containing four loops/channels per paddle for a total of eight channels for the two paddles. The second set of paddles is a pair of 10cm square containing four loops/channels per paddle for a total of eight channels for the two paddles. The third set of paddles is a single rectangular, interventional coil containing a single planar loop. All of these paddles connect to the same connector box containing eight preamplifiers; only one pair can be connected at a time. The coil design for all of the paddles has the same, simple antennae design and the same system connectivity configuration. The coils can be used in several configurations, including any single coil and any two coils, providing 1, 5 or 8 channels for imaging.

The DuoFLEX® Coil Suite (1.5T) 1500G-8R is a specialty magnetic resonance coil used in conjunction with a 1.5T MRI scanner to produce 2D and 3D images. The device is intended for use with GE Healthcare MR Systems and is classified as a Class II medical device (21 CFR 892.1000).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The documentation provided does not specify a distinct "test set" in the context of a clinical study or a separate dataset for evaluating an AI algorithm. The device is a hardware component (MRI coil), and its performance was primarily evaluated through non-clinical testing including bench tests, phantom studies, and volunteer scans. The exact number of volunteers or phantoms used for these tests is not specified, nor is the country of origin of the data. Given the nature of a 510(k) for a device like an MRI coil, the focus is on engineering and performance validation rather than large-scale clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. As per the submission, "This technology is not new, therefore a clinical study was not considered necessary prior to release. Additionally, there was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." Therefore, there was no "test set" in the sense of a clinical image dataset requiring expert-established ground truth for performance evaluation against a diagnostic standard. The "clinical comparison for image quality" described in the non-clinical testing refers to an evaluation of the images produced by the coil, not a diagnostic accuracy study.

4. Adjudication Method for the Test Set

Not applicable. As explained in point 3, there was no clinical study with a test set requiring adjudication in the context of diagnostic accuracy.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states that "This technology is not new, therefore a clinical study was not considered necessary prior to release." The device is an accessory to an MRI scanner, and its equivalence was demonstrated through non-clinical performance and safety testing compared to a predicate device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. This device is an MRI coil, which is a hardware component, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance evaluation focuses on the engineering and image acquisition capabilities of the coil.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established through:

• Engineering specifications and regulatory standards: for electrical safety, EMC, mechanical properties, and compliance with IEC 60601-1.
• Physical measurements: for SNR (NEMA MS-1 and MS-6) and image uniformity.
• Visual assessment: for image quality (clinical comparison for image quality, volunteer scans, and phantom/cadaver studies), likely made by engineers or experienced MRI operators, comparing the new device's output to established benchmarks or the predicate device's output.

8. Sample Size for the Training Set

Not applicable. This device is a hardware component and does not involve AI algorithms that require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm.

Ask a specific question about this device