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The NeoCoil 3.0T 6-Channel Carotid Array Coil is a receive only phased array RF coil used to produce diagnostic images of the carotid arteries that can be interpreted by a trained physician. The coil provides coverage of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging systems. The NeoCoil 3.0T 6-Channel Carotid Array Coil is designed for use with the HD series (3.0Tesla) MRI scanners manufactured by General Electric Healthcare (GEHC). Anatomic Regions: Head and neck vasculature. Nuclei Excited: Hydrogen.

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

The GE scanner 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 vasculature of the head and neck regions specifically the carotid arteries and associated soft tissue. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The NeoCoil 3.0T 6-Channel Carotid Array Coil is a multi-element phased array receive only coil used for obtaining diagnostic images of the carotid arteries and associated vasculature from the sternal notch through the internal carotid arteries at the level of cervical vertebrae C1 in Magnetic Resonance Imaging Systems. Compared to predicate devices, the submitted device offers greater SNR due to its operating field strength of 3.0T, and a larger field-of-view due to the antenna layout.

The submitted device consists of a dual set of foam covered "paddles", consisting of three antennas each. The three antennas in each paddle are uniquely positioned with the appropriate overlap to cancel out mutual coupling effects from adjacent antennas. Pre-amplifier decoupling reduces any remaining decoupling between the antennas.

The paddles are held in place over the imaging area via a headband. A system interface cable connects to the coil at the top of the headband. The foam paddles connect to the headband using a ball and socket joint that enable proper positioning of the paddles over the imaging area.

To ensure safety, each antenna is equipped with two transmit decoupling circuits; one active and the other passive. Active decoupling is achieved by PIN diodes that receive signals from the scanner to turn the coil to a high impedance state during system RF transmit. Crossed diodes are installed on each antenna acting as passive switches. These passive switched detune the antennas further during RF transmit.

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Implied Acceptance Criteria: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the primary "acceptance criteria" are not explicitly stated as numerical targets but are inferred from the claims of equivalence and the summary of studies. The "Summary of Studies" explicitly mentions "SNR and image uniformity testing was performed which support the conclusion that the submitted device satisfies design objectives," suggesting these were key performance metrics evaluated for substantial equivalence. The "Preliminary Product Data Sheet" provides specific "Coil Coverage (FOV)" and imaging capabilities, which are de facto performance specifications that the device is expected to meet.

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

• Sample Size for Test Set: The document does not specify a sample size for any human subjects or patient data used in testing. The summary of studies mentions "SNR and image uniformity testing," which typically involves phantom studies or a limited number of healthy volunteers, but no specific numbers are given.
• Data Provenance: The document does not specify the country of origin for any data or whether the data was retrospective or prospective. Given the nature of performance testing for an MRI coil, most testing would likely involve phantom studies and possibly prospective imaging of volunteers/patients within a clinical setting (though not explicitly stated).

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

• Number of Experts: The document does not mention the use of experts to establish ground truth for a test set. This type of testing (SNR, image uniformity) for an MRI coil primarily relies on quantitative physics measurements and visual assessment by qualified MR physicists or engineers.
• Qualifications of Experts: Not applicable, as expert review for ground truth is not indicated.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The summary of studies refers to technical performance metrics (SNR, image uniformity) rather than diagnostic performance requiring expert adjudication of clinical findings.

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

• MRMC Study Done? No. The document does not mention a multi-reader, multi-case comparative effectiveness study. This type of study is more common for AI-powered diagnostic tools where human interpretation is directly assisted or compared. This device is an MRI coil, a hardware component.
• Effect Size: Not applicable.

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

• Standalone Study Done? Yes, in a way. The "SNR and image uniformity testing" would be considered standalone performance of the coil (hardware). It measures the intrinsic capabilities of the device without human interpretation being directly part of the performance metric. However, it's not an "algorithm" in the typical software sense.

7. Type of Ground Truth Used

• Type of Ground Truth: For the "SNR and image uniformity testing," the ground truth would be based on quantitative physics measurements from phantoms and potentially measurements from human images. For image uniformity, it would also involve visual assessment against predefined quality standards. It is not clinical pathology, expert consensus on disease, or outcomes data.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a hardware component (an MRI coil), not an AI algorithm that requires a training set of data. Its design and validation rely on engineering principles, physics, and performance testing rather than machine learning training.

9. How Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for a hardware device.

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