(28 days)
i. Soft tissue and bone imaging of the spine and brain as allowed by the MRI system.
ii. Magnetic resonance angiography.
The 3.0T Pediatric Head and Spine Array, Catalog #808GE3000, interfaces with the G.E. 3.0 Tesla Excite® system. It has been designed and optimized to collect spine (cervical, thoracic, and lumbar) and brain image data from many overlapping coil groups. The multi-channel design utilizes the G.E. Phased Array Coil inouts and utilizes standard coil configuration files available on the G.E. system. The coil form geometry has been formed to facilitate close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest. The coil assembly comes with a comfort pad set to comfortably place the patient on the coil assembly.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) submission for a medical device (MRI accessory coil) and primarily details the device description, intended use, and substantial equivalence to a predicate device, leading to FDA clearance.
There is no information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or details of a test set.
- Ground truth establishment, including the number and qualifications of experts.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance studies.
- Types of ground truth used (e.g., pathology, outcomes data).
- Training set sample size or how its ground truth was established.
The document states that the new device has "minor changes to the size and physical orientation of the individual elements" and "the materials, use, and safety features are equivalent." It also notes that "Both are receive-only MRI antennas so no energy is imparted to the patient." This suggests that the clearance was based on demonstrating substantial equivalence in design and function, rather than extensive performance testing against acceptance criteria as might be seen for devices with more complex diagnostic or algorithmic components.
§ 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.