(27 days)
The Swoop® Portable MR Imaging System™ is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
The Swoop® system is a portable MRI device that allows for patient bedside imaging. The system enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device that is used for operating the system, providing access to patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage interactions. The system can generate MRI data sets with a broad range of contrasts. The user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to view imagery. The Swoop® system image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, and FLAIR sequences, specifically in terms of reductions in image noise and blurring.
The provided text describes a 510(k) premarket notification for the Hyperfine Swoop® Portable MR Imaging System™. It discusses the device's substantial equivalence to a predicate device and lists various non-clinical performance tests conducted. However, the document does not contain specific acceptance criteria, reported device performance metrics (like sensitivity, specificity, accuracy), details about a study proving the device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance studies, types of ground truth used, or training set sample sizes.
The "Non-Clinical Performance" section broadly states:
- Imaging Performance Test: "Testing to verify image performance meets all image quality criteria." The applicable standards listed are NEMA MS 1-2008 (R2020), NEMA MS 3-2008 (R2020), NEMA MS 9-2008 (R2020), NEMA MS 12-2016, American College of Radiology (ACR) Phantom Test Guidance for Use of the Large MRI Phantom for the ACR MRI Accreditation Program, and American College of Radiology standards for named sequences.
- Result: "The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence."
This indicates that the device underwent testing against established standards and internal requirements for image quality, and it passed these tests. However, the specific quantitative acceptance criteria and the detailed results showing how it met them are not provided in this regulatory summary. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical or performance study report.
§ 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.