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The 1.5T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 1.5T MRI scanner, as an accessory to produce 2D and 3D images.

The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.

The GE 6-Channel Phased Array Flex Coil is a surface coil used for Magnetic Resonance Imaging. It is tuned to image proton nuclei in a receive-only configuration. It is comprised of 6 individual phased array coil elements, each utilizing an integrated preamplifier to improve image quality. This coil is a receive-only, multi-coil array optimized for high-resolution examinations. The coil enables multi-oblique slice imaging. The coil is indicated for use, on the order of a physician in conjunction with an MR scanner, as an accessory to produce 2D and 3D images.

The provided document pertains to a 510(k) Premarket Notification for the GE 6-Channel Phased Array Flex Coil. This device is an accessory for Magnetic Resonance Imaging (MRI) scanners and is not an AI/ML-powered device. Therefore, the typical acceptance criteria and study design for AI/ML devices, such as performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods, are not applicable here.

The document states that the GE 6-Channel Phased Array Flex Coil did not require clinical studies to support substantial equivalence (Page 3). This is a crucial point regarding the "study that proves the device meets the acceptance criteria." Instead, GE Healthcare asserted substantial equivalence to a predicate device (K042844) based on non-clinical tests and technological similarity.

Here's an analysis of what is available from the document in relation to your request, adapted for a non-AI/ML medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI/ML device submission, the "acceptance criteria" are related to safety and effectiveness, demonstrated through compliance with voluntary standards and non-clinical testing, rather than performance metrics like sensitivity or specificity.

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

• Test Set Sample Size: Not applicable. The device did not undergo a clinical test set in the traditional sense for performance evaluation against a specific ground truth.
• Data Provenance: Not applicable for a clinical test set. The submission focuses on non-clinical engineering and safety verification. The document mentions "clinical images from validation have been included in DICOM format in Section 20 of the submission" (Page 3), but this is not framed as a rigorous clinical "test set" for performance metrics and does not provide details on sample size or provenance.

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

• Not applicable as there was no clinical "test set" requiring ground truth establishment by external experts for performance evaluation. The "ground truth" for the non-clinical tests would be defined by engineering specifications and safety standards.

4. Adjudication Method for the Test Set

• Not applicable as there was no clinical "test set" requiring adjudication.

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

• No MRMC comparative effectiveness study was done, as this is a non-AI/ML accessory device and clinical studies were not required for its substantial equivalence determination (Page 3).

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

• Not applicable, as this is a physical MRI coil accessory, not an algorithm.

7. Type of Ground Truth Used

• For the non-clinical studies and verification tests, the "ground truth" would be the engineering specifications, voluntary standards (e.g., for safety and performance of MRI coils), and established benchmarks for image quality. There is no mention of pathology or outcomes data as "ground truth" for this type of device submission.

8. Sample Size for the Training Set

• Not applicable, as this is not an AI/ML device requiring a training set.

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

• Not applicable, as this is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the GE 6-Channel Phased Array Flex Coil meets acceptance criteria (for substantial equivalence) was non-clinical. The submission relied on a comparison to a predicate device (K042844) and a battery of engineering and safety tests.

The document explicitly states: "The subject of this premarket submission, GE 6-Channel Phased Array Flex Coil, did not require clinical studies to support substantial equivalence. However, clinical images from validation have been included in DICOM format in Section 20 of the submission." (Page 3).

The "acceptance criteria" were met by demonstrating:

• Compliance with voluntary standards.
• Completion of a robust development and testing process including risk analysis, requirements reviews, design reviews, and various levels of verification (unit, integration, performance, safety) and simulated use testing (validation).
• The device employs the same fundamental scientific technology as its predicate device, with modifications primarily to electrical components in the connector to allow compatibility with newer MR systems.

The FDA's letter (Page 5-7) confirms that based on the provided information, the device was found substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This indicates that the non-clinical evidence provided was sufficient for the FDA's regulatory requirements for this type of device.

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