(98 days)
The Mayo Clinic BC-10 1.5T wrist coil will be used in conjunction with several commercially available MRI systems to more accurately image a variety of maladies associated with the hand, wrist, forearm, and elbow. Maladies include, but are not limited to, carpal tunnel syndrome, nerve compression, ligament injuries, tendon abnormalities, and scarring. Its 10cm diameter design governs the specific area of the body which can be imaged.
The Mayo Clinic BC-10 magnetic resonance coil is a transmit/receive, high-pass, quadrature coil using the birdcage circuit design.
Due to the nature of the provided document, which is a 510(k) summary for a medical device (a dedicated MRI coil), it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report comparing the performance of an AI algorithm to established acceptance criteria. Therefore, most of the requested information regarding AI algorithm performance and study methodology is not present in the document.
However, I can extract the available information related to the device's performance and the general nature of the testing mentioned.
Here's a breakdown of what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document states: "Testing was performed to demonstrate the Mayo Clinic BC-10 performed in accordance with predetermined acceptance criteria and that the safety and reliability of the coil meets/exceeds standards." However, the specific pre-determined acceptance criteria or numerical reported device performance are not detailed in this summary. The summary focuses on comparing features to predicate devices.
| Feature | Mayo Clinic BC-10 (Reported Performance - as presented in comparison) | Acceptance Criteria (Not explicitly stated numerically in this summary) |
|---|---|---|
| Coil Type | High-pass, quadrature, T/R | Performance in line with "high-pass, quadrature, T/R" coil characteristics for MRI applications, demonstrating safety and reliability. |
| Region of Interest | Small extremities |
§ 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.