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The 3.0T 8-Channel CTL Array Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the spine (cervical, thoracic and lumbar regions) in Magnetic Resonance Imaging Systems. The indications for use are the same as for standard MR Imaging. The 3.0T 8-Channel CTL Array Coil is designed for use with the GE Medical Systems 3.0Tesla MRI scanner.

The 3.0T 8-Channel CTL Array Coil is designed to provide Magnetic Resonance Images of the cervical, thoracic, and lumbar regions of the spine. The 3.0T 8-Channel CTL Array Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

Anatomic Regions: cervical, thoracic, and lumbar regions of the spine Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The 3.0T 8-Channel CTL Array Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the spine and has been designed to maximize comfort and ease of use. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

This document describes a 510(k) premarket notification for a medical device, specifically a "3.0T 8-Channel CTL Array Coil" for Magnetic Resonance Imaging. The information provided heavily focuses on proving "substantial equivalence" to predicate devices rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new device. Therefore, many of the requested sections (2-9) cannot be fully populated as they pertain to a detailed clinical or standalone performance study, which is not present in this submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document provided is a 510(k) summary, which often focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel clinical study with explicit acceptance criteria for performance metrics. The "acceptance criteria" here are essentially the characteristics and safety features of the predicate devices. The "reported device performance" is the statement that the new device shares similar characteristics and capabilities with these predicate devices. The submission essentially argues that because the new device is "similar to" already approved devices in key safety and functional aspects, it is equally safe and effective.

Detailed breakdown of study information (where available):

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

• Not explicitly stated. The submission relies on demonstrating similarity to predicate devices rather than a direct performance study with a test set of images/patients. There is no information on a specific test set, its size, or its provenance.

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. There is no mention of a test set with ground truth established by experts in this submission. The "ground truth" for this 510(k) is effectively the established safety and efficacy profiles of the predicate devices.

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

• Not applicable. No test set or expert adjudication is described.

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 device is an MRI coil, a hardware component. The submission does not describe any AI component or any MRMC study involving human readers.

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

• Not applicable. This is a hardware component (MRI coil), not an algorithm. Standalone algorithm performance is not relevant.

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

• Not applicable in the context of a new device performance study. The 'ground truth' for this 510(k) is the legal and scientific consensus that the predicate devices are safe and effective for their intended use. The new device is deemed safe and effective because it is substantially equivalent.

8. The sample size for the training set

• Not applicable. This submission does not describe a training set as it's not an AI/algorithm-based device.

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

• Not applicable. As above, there is no training set described.

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