(14 days)
The 1.5T Brain / Spine Array Coil is designed for use with the 1.5T MRI system manufactured by GE Healthcare. The coil is for imaging of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine. The nucleus excited is hydrogen. The 1.5T Brain / Spine Array Coil is designed for use with the 1.5T MRI systems manufactured by GE Medical Systems.
The 1.5T Brain / Spine Array Coil is a receive-only RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck, upper chest, thoracic and lumbar spine in GE 1.5T MR Imaging systems.
The open design of the 1.5T Brain / Spine Array Coil reduces claustrophobic effects and allows for increased patient comfort. The coil elements are enclosed in a rigid plastic housing. The housing is designed to conform to the patient anatomy. The design of the coil allows for easy positioning of the patient and provides patient comfort.
The mechanical housing of 1.5T Brain / Spine Array Coil consists of four main parts: (1) a main head coil base, (2) a split-top head coil housing (3) a chest coil housing and (4) a T-L Spine housing. The chest coil housing is free floating and it rests on the patient's chest.
The 1.5T Brain / Spine Array Coil has an array of 21 coil elements in the Brain Unit and 8 coil elements in the Spine Unit; The 21 coil elements in the brain unit are Loop elements. Twelve loop coils (L1 to L12) cover the head region. Another four loop coils (L13 to L16) cover the Lower neck and torso regions. Five Loop coils (L17 to L21) cover the upper neck and the chest region. The Spine Unit has an array of four loop coils and four saddle coils which cover the thoracic and lumbar spine regions.
For operation, the 1.5T Brain / Spine Array Coil does not require any change to the software used on the GE Medical Systems Inc. 1.5T MRI system.
The provided text describes a 510(k) summary for a Magnetic Resonance Imaging Accessory, specifically the 1.5T 16 Channel Brain-Spine Array Coil. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria for an AI/ML device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and AI-specific study details (MRMC, standalone performance) cannot be extracted from this document, as it pertains to the approval of an MRI coil, not an AI/ML diagnostic algorithm.
The document indicates that "Testing was performed to demonstrate that the design modifications to the 1.5T Brain / Spine Array meet predetermined acceptance criteria." However, it does not specify these criteria or the results of the testing.
No information regarding acceptance criteria or a study with performance metrics for an AI/ML device is available in the provided text.
Here's a breakdown of why the requested information is absent or not applicable:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The document states "Testing was performed to demonstrate that the design modifications... meet predetermined acceptance criteria," but does not list these criteria or the test results.
- 2. Sample size used for the test set and the data provenance: Not provided. This information is relevant for AI/ML device studies, not for the approval of an MRI coil based on substantial equivalence.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment for image interpretation is not part of an MRI coil's 510(k) submission based on substantial equivalence.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 is for AI-assisted diagnostic devices, not MRI hardware.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. This is for AI/ML device development.
- 9. How the ground truth for the training set was established: Not applicable.
Summary from the provided text:
The submission focuses on the substantial equivalence of the "1.5T 16 Channel Brain-Spine Array Coil" to a legally marketed predicate device (Millennium 9000 Phased Array Neurovascular coil K001870). The changes primarily involve physical integration of components and an increased number of receive channels (to 16) to be compatible with GE Healthcare Signa Excite 1.5T MRI Scanners. The comparison emphasizes improved user workflow and more comprehensive patient coverage. The "Summary of Studies" section vaguely mentions "Testing was performed to demonstrate that the design modifications to the 1.5T Brain / Spine Array meet predetermined acceptance criteria," but no details on these criteria or the study results are provided.
§ 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.