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The GEM RT Open Array Coil that is a part of the Oncology Suite is a receive-only RF coil designed for use with 1.5T MRI systems manufactured by GE Healthcare. The indications for use include the head, neck, and brachial plexus anatomies and vasculature imaging. The nucleus excited is hydrogen.

The 1.5T GEM RT Open Array is a receive only 8-Channel 8-element Posterior Phased Array, for use as an option to the Optima MR450w MR Systems with GEM suites. It is a posterior array which can be inserted into the GEM Table cradle (K103335) at either the head or foot end.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GE Healthcare 1.5T GEM RT Open Array:

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to diagnostic accuracy or clinical effectiveness. The submission is for a medical device that appears to be an RF coil for an MRI system, not an AI/ML powered device, hence most of the questions posed (e.g., effect size of human readers improving with AI, standalone performance, training set details) are not applicable.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical tests related to safety and performance standards of the coil itself, rather than its diagnostic output.

However, based on the non-clinical tests described, we can infer some "acceptance criteria" related to the device's technical specifications and safety compliance.

Here's a breakdown of the requested information, adapted to what is actually available in the document:

Analysis of Acceptance Criteria and Proving Study for GE Healthcare 1.5T GEM RT Open Array

1. A table of acceptance criteria and the reported device performance:

Since this is a submission for an MRI RF coil, not an AI/ML diagnostic device, the acceptance criteria are focused on safety, electromagnetic compatibility, and technical performance related to signal quality. The document states compliance with established standards.

2. Sample size used for the test set and the data provenance:

• Sample Size: The document explicitly states: "The subject of this premarket submission, 1.5T GEM RT Open Array, did not require clinical studies to support substantial equivalence." Therefore, there is no formal "test set" in the context of clinical images or patient data for evaluating diagnostic performance. "Sample clinical images have been included in this submission," but these are not described as part of a formal test set with defined sample size for performance evaluation.
• Data Provenance: Not applicable as a formal clinical test set was not used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as a formal clinical test set requiring expert ground truth for diagnostic accuracy was not established. The evaluation focused on technical and safety compliance.

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

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

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:

• No. This device is an MRI RF coil, not an AI/ML driven diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant or applicable.

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

• No. This device is a hardware component (an RF coil) for an MRI system, not an algorithm or AI. Standalone algorithm performance is not applicable.

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

• For the non-clinical tests, the "ground truth" was compliance with established technical and safety standards (e.g., IEC, NEMA). This involves engineering measurements and evaluations against predefined specifications rather than clinical pathology or expert consensus on diagnostic findings.

8. The sample size for the training set:

• Not applicable. This is a hardware device submission, not a machine learning model. There is no concept of a "training set" in the context of this submission.

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

• Not applicable, as there is no training set.

Summary of Conclusions from the Document:

The GE Healthcare 1.5T GEM RT Open Array coil achieved FDA clearance (K123327) by demonstrating substantial equivalence to a predicate device (K103335, GEM Option for 1.5T MRI Systems) based on:

• Non-clinical testing: Compliance with established international and industry standards for electrical safety (IEC 60601-1, IEC 60601-2-33), electromagnetic compatibility (IEC 60601-1-2), and MRI image quality characteristics like Signal-to-Noise Ratio (SNR) and Uniformity for phased array coils (NEMA MS-9).
• Quality assurance measures: The development process included risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, simulated use).
• No clinical studies were required to support substantial equivalence for this specific device.

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