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The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.

The 48CH Head Coil is a phased-array receive-only coil designed to provide optimum signal-to noise, uniform coverage and high acceleration including multiband imaging of the head and brain. It is a 48-element coil tuned to image proton nuclei and designed for use with GE 3.0T MRI Systems. Each coil element has an integrated preamplifier to improve image quality. The 48CH Head Coil has an anterior coil and a posterior coil with P-connectors. The coil has optimized pads to maximize patient comfort and image uniformity.

This document is a 510(k) premarket notification for a medical device, specifically a 48CH Head Coil for MRI systems. The FDA letter and the 510(k) summary provided indicate that this device is being submitted as substantially equivalent to a previously cleared predicate device (48CH Head Coil, K163205).

Key takeaway: The regulatory submission explicitly states that clinical studies were not required to support substantial equivalence for this device. This means the information requested about acceptance criteria, detailed study design (sample size for test/training sets, number of experts, adjudication, MRMC, standalone performance, ground truth establishment) is largely not applicable in the context of this specific 510(k) submission.

The submission focuses on non-clinical testing to demonstrate that the device is as safe and effective and performs in a substantially equivalent manner to the predicate, despite a minor design change (decoupling circuit).

Therefore, I cannot provide the requested information about acceptance criteria for a clinical study or a detailed study description because the submission states that no clinical studies were performed or required.

Here's what can be extracted and inferred from the provided text regarding the closest equivalent to "acceptance criteria" and "study" for this specific type of submission:

Acceptance Criteria and Study for Substantial Equivalence (Non-Clinical Focus)

Since this 510(k) relies on substantial equivalence established through non-clinical testing, the "acceptance criteria" are not for clinical performance metrics (like sensitivity/specificity of an AI algorithm), but rather for demonstrating that the new device performs equivalently to the predicate in terms of safety and technical specifications.

1. Table of "Acceptance Criteria" and "Reported Device Performance" (Non-Clinical Context):

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

• Not Applicable. No clinical test set data was reported as part of this 510(k) submission. The testing performed was non-clinical (e.g., electrical, thermal, mechanical bench testing).
• The document explicitly states: "The subject of this premarket submission, the 48CH Head Coil, did not require clinical studies to support substantial equivalence."

3. Number of Experts Used and Qualifications:

• Not Applicable. No clinical ground truth was established by experts for a test set, as no clinical study was performed or required.

4. Adjudication Method:

• Not Applicable. No clinical test set to adjudicate.

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

• Not Applicable. No clinical study comparing human reader performance with or without AI assistance was conducted or reported. This device is an MRI coil, not an AI-powered diagnostic algorithm.

6. Standalone (Algorithm Only) Performance:

• Not Applicable. This device is an MRI coil, not a standalone algorithm.

7. Type of Ground Truth Used:

• Not Applicable for clinical ground truth. For the non-clinical testing, the "ground truth" would be established engineering specifications, safety standards (e.g., IEC 60601 series), and performance metrics of the predicate device against which the new device was compared (e.g., signal-to-noise ratio measurements, temperature limits, B1 field uniformity targets).

8. Sample Size for the Training Set:

• Not Applicable. This device is an MRI coil, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not Applicable. No training set exists for this type of device.

In summary, the provided document clearly states that this 510(k) submission for the 48CH Head Coil did not require clinical studies to demonstrate substantial equivalence, relying instead on non-clinical testing. Therefore, the detailed questions related to clinical study design, data, experts, and ground truth are not applicable to the information contained within this regulatory filing.

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The 3.0T 48CH Head Coil is a receive-only RF coil designed for use with select 3.0T MRI systems manufactured by GE Healthcare. The coil is indicated for use for head imaging. The nucleus excited is hydrogen.

The 48CH Head Coil is a phased-array receive-only coil designed to provide optimum signal-to noise, uniform coverage and high acceleration including multiband imaging of the head and brain. It is a 48-element coil tuned to image proton nuclei and designed for use with GE 3.0T MRI Systems. Each coil element has an integrated preamplifier to improve image quality and a custom MEMS (Micro Electro Mechanical System) switch to decouple the receive coil from the MR System body coil. The 48CH Head Coil has an anterior coil and a posterior coil with P-connectors. The coil has optimized pads to maximize patient comfort and image uniformity.

The provided document describes a 510(k) premarket notification for the GE Healthcare 48CH Head Coil. This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria for diagnostic performance.

Therefore, the information you requested about acceptance criteria and how a study proves the device meets them, particularly regarding AI performance, human reader improvement, and ground truth establishment, is largely not present in this submission. This is typical for a device like an MRI coil, where the focus is on safety, technical performance (signal-to-noise ratio, uniformity, etc.), and demonstrating that it operates similarly to existing approved devices.

Here's a breakdown of what can be extracted from the document, and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of clinical acceptance criteria for diagnostic imaging performance (e.g., sensitivity, specificity for detecting specific conditions). Instead, it focuses on non-clinical technical performance and safety.

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

• Test set for clinical performance: "The subject of this premarket submission, the 48CH Head Coil, did not require clinical studies to support substantial equivalence. Sample clinical images have been included in this submission." This indicates that there was no formal clinical test set for diagnostic performance as would be used for an AI device. The included "sample clinical images" are likely illustrative rather than for formal evaluation.
• Data provenance: Not applicable for a separate clinical test set.

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

Not applicable, as no dedicated clinical test set with ground truth was required for this submission.

4. Adjudication method for the test set

Not applicable, as no dedicated clinical test set with ground truth was required for this submission.

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 MRMC study was conducted or reported. This device is an MRI coil, not an AI-powered diagnostic tool.

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

Not applicable. This device is an MRI coil, not an algorithm.

7. The type of ground truth used

Not applicable for clinical performance. For non-clinical tests, the ground truth would be based on engineering specifications, physical measurements, and compliance with established safety standards.

8. The sample size for the training set

Not applicable. This is a hardware device (MRI coil), not a software algorithm requiring a training set in the AI sense.

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

Not applicable.

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