(89 days)
The HI STAR system is indicated for use a general purpose MR imager that produces transverse, sagittal, coronal, and oblique cross-sectional images of internal structures of the human body, head, and extremities. Contrast in these images reflect the intrinsic oroperties of the hydrogen proton, proton density, T1, and T2, and the extrinsic parameters of the applied imaging sequences. The indications for the HI STAR do not differ significantly from the predicate, or legally marketed devices.
The Health Images HI STAR is a proton (H-1) Magnetic Resonance Imaging device. The HI STAR has been designed to produce transverse, sagittal, coronal, and oblique section images of the head, body and extremities of the human body. Contrast in these images is produced primarily by T1, T2, and proton density tissue characteristics. This imager employs conventional MRI imaging techniques in which the application of a combination of pulsed radio frequency energy and magnetic gradient fields is applied to the body to generate MR proton echo signals. These multidimensionally coded signals are converted by Fourier transform into 2D and 3D image sets.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:
It's important to note that this document is a 510(k) Summary from 1997, specifically for a Magnetic Resonance Imager (MRI). The nature of acceptance criteria and supporting studies for such a device at that time, and compared to a more modern AI/software-as-a-medical-device (SaMD) submission, will be different. This document focuses on hardware performance and safety rather than diagnostic accuracy of an AI algorithm.
1. A table of acceptance criteria and the reported device performance
The document provides "Safety Parameters" and "Imaging Performance Parameters" which function as acceptance criteria for the MRI device.
| Parameter Criterion | Acceptance Criteria (FDA Limit/Standard) | Reported Device Performance (HI STAR) |
|---|---|---|
| Safety Parameters | ||
| Maximum Static Magnetic Field | ≤ 2 tesla | 0.6T |
| Rate of Magnetic Field Strength change | ≤ 20 T/second |
§ 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.