(65 days)
The E-Scan is intended for diagnostic nuclear magnetic resonance imaging of the hip, leg, knee, ankle, foot, shoulder, elbow, forearm, wrist and hand. The device produces transverse, sagittal, coronal and oblique cross-sectional images, displaying the internal structure of the limbs and joints 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 system preliminarily named "Artoscan S" is going to be commercialized under the trade name "E-Scan". The changes performed, with respect to the cleared version, are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort. The intended use of the modified device has not changed as a result of the modifications nor such modifications alter its fundamental scientific technology.
The E-Scan is a Magnetic resonance diagnostic device. It is a System, Nuclear Magnetic Resonance Imaging. The changes performed, with respect to the cleared version (Artoscan S), are due to the optimization process of the system, in particular in relation to an improvement of the accessibility inside the gantry and therefore toward a greater patient comfort.
Here's an analysis of the provided K990968 document, focusing on acceptance criteria and supporting studies.
It's important to note that this document is a 510(k) summary for a Magnetic Resonance Diagnostic Device (E-Scan) from 1999. The submission focuses on demonstrating substantial equivalence to a predicate device (Artoscan S), rather than presenting a performance study with detailed acceptance criteria as one might expect for a modern AI/software device. Therefore, many of the requested categories for AI device studies will not be directly applicable or present in this type of submission.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria here are implicitly based on demonstrating that the E-Scan device is substantially equivalent to its predicate device, the Artoscan S. The performance metrics are relative to the predicate, showing that the E-Scan maintains or improves upon the predicate's capabilities.
| Acceptance Criteria Category | E-Scan Performance (relative to Artoscan S) |
|---|---|
| Imaging Parameters | |
| Slices per Echo | 1 - 96 (vs. 1 - 128 for Artoscan S). Comment: This is a reduction, but likely deemed acceptable as it still covers a wide range and does not negatively impact safety or effectiveness for the intended use. |
| 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.