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The GE 3.0T General Purpose Flex Coil is designed to facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh. The GE 3.0T General Purpose Flex Coil will facilitate dynamic MR imaging of the joints of lower extremity (Knee and Ankle). This coil consists of two 5" x 6.5" surface coils coupled as a Helmholtz pair in a flexible package that can be wrapped around the anatomy of interest. This flexibility allows for the coil to be applied to a wider range of patients when compared to a similar coil in a rigid package. The coil is an option to the GE Signa® 3.0T whole body MR System.

The GE 3.0T General Purpose Flex Coil is a modification of the existing 1.5T GP Flex Coil (K923264), to increase the field strength from 1.5T to 3.0T. In addition, two passive blocking networks are added to improve reliability and patient safety.

This GE 3.0T General Purpose Flex Coil is a magnetic resonance coil, not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation. Instead, the document discusses the substantial equivalence of the new 3.0T coil to an existing 1.5T coil.

Here's an analysis of what is provided and why the requested information is absent:

The document states: "Testing was performed to demonstrate that the design modifications to the 1.5T general Purpose Flex coil meet predetermined acceptance criteria." However, it does not detail what those "predetermined acceptance criteria" were or the specific results of that testing quantitatively.

The core of this submission is a claim of substantial equivalence to an existing cleared device (GE Medical Systems 1.5T GP Flex coil M1085GP (K923264)). This means the device is being marketed as essentially the same in terms of safety and effectiveness as a predicate device, rather than a novel device requiring extensive performance studies as would be the case for many AI/ML technologies.

Therefore, I cannot populate the requested table or answer most of the questions as they pertain to the evaluation of an AI/ML diagnostic device, which this product is not.

However, I can provide what information is available based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• This is not an AI/ML device study, so the concept of a "test set" and "data provenance" in this context is not applicable. The "testing" mentioned would likely involve engineering verification and validation (e.g., electrical safety, mechanical integrity, SAR compliance, image quality comparisons) rather than clinical performance on a dataset of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not applicable as this is not an AI/ML diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable.

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 medical device (MR coil), not an AI/ML software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable; this is a hardware device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. For a device like this, "ground truth" would relate to its physical and functional specifications (e.g., signal-to-noise ratio, uniformity, SAR values) compared to engineering design requirements and the performance of the predicate device.

8. The sample size for the training set:

• Not applicable; this is a hardware device, not an AI/ML algorithm.

9. How the ground truth for the training set was established:

• Not applicable.

Summary of available information from the document:

• Device Type: Magnetic Resonance Coil (hardware)
• Purpose: To facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh, and dynamic MR imaging of the joints of the lower extremity (Knee and Ankle) at 3.0T field strength.
• Key Modification: Retuning from 1.5T to 3.0T and addition of two passive blocking networks for reliability and patient safety.
• Justification for Market: Substantial equivalence to an existing 1.5T GP Flex Coil (K923264).
• Type of Study Performed: "Testing was performed to demonstrate that the design modifications to the 1.5T general Purpose Flex coil meet predetermined acceptance criteria." (Specific criteria and results are not detailed in this summary).
• Conclusion: The device is substantially equivalent, and its usage "does not result in any new potential hazards."

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