(14 days)
Imaging of:
- Diagnostic imaging of the knee, ankle and foot regions
- Fluid visualization
- 2D and 3D imaging
- MR angiography
- MR fluoroscopy
The QD KNEE/FOOT COIL is QD volume coil that can transmit RF and receive NMR signal from like the knee or other extremity regions.
The QD KNEE/FOOT COll. is comprised of coil element and PC board. The coil element shapes STIR type coil. The PC board switches transmit mode and receive mode with PIN diodes and combines the NMR signals.
The QD KNEE/FOOT COIL is constructed with the same materials that are currently in use for the released QD KNEE COIL.
The provided text describes a 510(k) summary for a medical device called the "QD KNEE/FOOT COIL." It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a clinical study for an AI/ML medical device would.
This document is a premarket notification for a hardware accessory (an MRI coil) and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than performance against a set of quantitative acceptance criteria in a study. The information provided is about the device's technical specifications and intended use.
Therefore, many of the requested categories cannot be answered from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document doesn't outline specific "acceptance criteria" in the sense of predefined thresholds for performance metrics (e.g., sensitivity, specificity, accuracy) that an AI device would need to meet. Instead, it details safety parameters and imaging performance parameters, which are more akin to technical specifications for the hardware. The "reported device performance" is largely qualitative, referring to sample images.
| Parameter | Acceptance Criteria (Implicit/Stated) | Reported Device Performance |
|---|---|---|
| Safety Parameters | ||
| Maximum static field strength | 1.5 Tesla (This is a specification of the compatible MRI system, not the coil's intrinsic performance, but implies it must operate safely at this field strength) | N/A (The coil is designed for a system with this field strength) |
| Rate of change of magnetic field | 30 mT/second (Maximum safe rate of change for the compatible MRI system) | N/A |
| Maximum radio frequency power deposition (SAR) |
§ 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.