(12 days)
The EchoStar 1.5 T MR System is a whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique planes may be imaged. MRI images produced by the EchoStar system reflect the spatial distribution of the density of hydrogen nuclei (protons), spin-latice relaxation time (TI), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images yield information that can be useful in the determining of a diagnosis. This device is intended for prescription use only.
The EchoStar 1.5 T MR System is a whole-body magnetic resonance imaging (MRI) system.
I apologize, but the provided text from the FDA 510(k) letter for the "EchoStar 1.5 T MR System" does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them.
The letter is a regulatory document confirming clearance for marketing based on substantial equivalence to a predicate device. It states the indications for use but does not delve into the specific performance studies, acceptance criteria, or methodological details you've requested.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies based on this document.
To answer your request, I would need access to the full 510(k) submission, specifically the sections related to performance data and testing.
§ 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.