(80 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the knee , foot, and ankle that can be interpreted by a trained physician.
Model KAC-63 Knee Array Coil
This document package is a 510(k) clearance letter and an Indications for Use statement for the KAC-63 Knee Array Coil. This type of regulatory document typically does not contain detailed studies or acceptance criteria tables like those for AI/ML-based diagnostic devices.
Instead, the process for a device like a coil focuses on demonstrating substantial equivalence to a predicate device. This usually involves:
- Performance Benchmarking: Demonstrating that the new device performs at least as well as, and is safe and effective as, the predicate device in terms of image quality, signal-to-noise ratio (SNR), and other physical parameters relevant to its function.
- Safety Testing: Ensuring the device meets electrical safety standards, biocompatibility (if applicable), and does not pose undue risks to patients during MRI scanning.
- Compliance with Standards: Adhering to relevant industry standards for medical devices and MRI equipment.
Therefore, I cannot provide the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, etc.) because this type of information is not present in the provided documents for a device like an MRI coil. These documents confirm regulatory clearance based on substantial equivalence, rather than a clinical performance study with specific diagnostic accuracy metrics, which would be common for AI-driven diagnostic software.
§ 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.