(75 days)
The intended use of Paramed's Mr. Inspire with Extended is for diagnostic nuclear magnetic resonance imaging of hip, knee, ankle, foot, shoulder, elbow, wrist, hand, calf, thigh, arm, forearm, Temporo Mandibular Joint (TMJ), with limitation to joint pathologies (no turnors, no angiography) If equipped with the Extended kit (code 01-1872-01) the MrJ Inspire device can also produce images of the C-Spine and L-Spine joinls. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joint being imaged. The images that are produced correspond to the spatial distribution of protons (hydrogen nuclei) that check the magnetic resonance properties and depend upon the MR parameters (spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and chemical shift). If interpreted by a medical expert, these images can provide diagnostically useful information.
The Mr Inspire is a magnetic resonance imaging device characterized by an open structure to minimize claustrophobic reactions. The magnet is a permanent "C" shaped joke designed to minimize the installation area and the Controlled Access area in order to fit also very small hospital and clinics.
The provided text is a 510(k) summary for the Paramed Mr Inspire MRI system. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, much of the requested information cannot be extracted directly from this document because the regulatory pathway for this device is based on substantial equivalence to existing devices, not on proving explicit performance against pre-defined clinical acceptance criteria like those expected for novel diagnostic algorithms.
Here's a breakdown of what can be inferred or is missing, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present explicit "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting pathologies) for the Mr Inspire. Instead, it compares technical parameters to its predicate device, the MrJ. The implicit acceptance criterion is that the technical parameters and image quality are equivalent or better than the predicate device.
| Parameter (from document) | Mr Inspire Reported Performance | Acceptance Criteria (Implied: Equivalent to predicate MrJ) |
|---|---|---|
| Magnetic field strength | 0.22 T | 0.22 T |
| Stray field 5G | maximum 80 cm from magnet covers | maximum 80 cm from magnet covers |
| Weight | 4200 Kg | 4200 Kg |
| Homogeneity |
§ 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.