(29 days)
The GE 3.0T 16 Channel Head Neck Spine Coil is a receive-only RF coil designed for use with the 3.0T MRI system manufactured by GE Healthcare. The coil is intended for imaging of the brain; cervical, thoracic, and lumbar spines; as well as the soft tissues and vasculature of the head, neck, and upper chest. The nucleus excited is hydrogen.
The 3.0T Head Neck and Spine Coil is a receive-only 16-channel, 29-element coil designed for use with GE 3.0T MRI Systems. This rigid coil incorporates soft, flexible components that conform to patients' anatomy, accommodating various body contours while minimizing patient discomfort. The Head, Neck and Spine Array (HNS) coil is comprised of 4 units: the Head/ Neck Unit (HNU), the Thoracic/ Lumbar unit (TLU) and the Neck Chest Unit (NCU) and Horseshoe. The 3.0T HNS Coil has an array of 21 coil elements in the head neck units and 8 coil elements in the Spine Unit. Twelve coil elements cover the head region. Another four coil elements cover the lower neck and Brachial Plexus regions. Five coil elements cover the upper neck and the chest region. The Spine Unit has an array of 8 coil elements, which cover the thoracic and lumbar spine regions. The 3.0T 16 Channel Head Neck Spine Coil is a multi-element phased array RF Receive only coil with integrated preamplifiers. The coil design consists of RF chokes with switching diodes to provide decoupling which isolates the coil elements from RF fields during RF transmission.
The provided text describes a 510(k) premarket notification for a medical device, specifically a 3.0T 16 Channel Head Neck Spine Coil for MRI systems. While it outlines the device's technical specifications, intended use, and its substantial equivalence to predicate devices, it does not contain information regarding acceptance criteria, performance studies, or clinical trial data.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics, pass/fail criteria, or the results of any performance tests.
- Sample size used for the test set and the data provenance: There is no mention of a test set or the data used for any performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present as there's no described test set or ground truth establishment.
- Adjudication method for the test set: Not applicable as no test set or adjudication process is mentioned.
- 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: This is a hardware device (an MRI coil), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As mentioned above, this is a hardware device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is discussed.
- The sample size for the training set: Not applicable as this is a hardware device and not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable for the same reason.
The document primarily focuses on establishing "substantial equivalence" to existing predicate devices based on design, intended use, and technological principles, which is common for 510(k) submissions for devices like MRI coils. It's not a clinical study report or a performance evaluation for an AI/software device.
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.