(87 days)
The intended use for the device family is to provide form fitting MRI antenna sets to facilitate targeting imaging of various musculoskeletal extremity regions using a GE 3.0T MRI scanner. The Indications for use are:
- Soft tissue and bone imaging of the extremities as allowed by the MRI system. .
- Magnetic resonance peripheral angiography.
The individual coils that comprise the Extremity Coil Family interface with a 3.0 Tesla, 8channel MRI scanner.
All coils included in the Extremity Set are extremely similar in design, construction, materials and operation. There are slight variations in physical size (to accommodate differing patient sizes), and slight physical housing variations (required to optimize the image quality depending on the extremity anatomy). The designs and matcrials used to manufacture the individual coils are nearly identical and are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing has been formed by utilizing a semi-rigid housing in conjunction with semi-flexible flaps and/or padding that facilitates close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest on a broad size variation of patient anatomy. All employ similar blocking, impedance matching and integrated pre-amplifier circuitry.
The provided text is a 510(k) summary for the Extremity Coil Family, which describes MRI coils. This type of document is for a medical device that serves as an accessory to an imaging system (MR scanner). It focuses on establishing substantial equivalence to a predicate device, rather than proving the performance of a diagnostic algorithm or AI.
Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness with AI is not applicable to this submission. These coils are hardware components whose performance is typically evaluated based on engineering specifications related to signal-to-noise ratio (SNR), image uniformity, and physical compatibility with the MRI scanner.
The document confirms that this device is a basic MRI coil, not an AI-driven diagnostic tool. It states: "The designs and materials used to manufacture the individual coils are nearly identical and are no different from standard MRI coil technology that has existed for years."
No study related to AI or diagnostic performance is mentioned in the provided text.
§ 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.