(36 days)
The IMRIS Neuro II-SE MRI system is indicated for use for the head and whole body.
The Neuro II-SE is intended for use as a diagnostic patient imaging device. This device produces tomographic cross-sectional images that:
- correspond to the distribution of protons exhibiting MR characteristics;
- depend upon NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1) and spin-spin relaxation time (T2); and
- display the soft tissue structure of the body.
When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
The Neuro II-SE may also be used during intra-operative procedures when performed in an intra-operative MRI suite with MR compatible devices such as anesthesia and patient monitoring equipment.
The Neuro II-SE may also be used in a multi-room suite.
The Neuro II-SE system is a traditional MRI unit that has been suspended on an overhead rail system to facilitate intra-operative use. The main components of the Neuro II-SE system are the Espree MRI System (including diagnostic coils), the Magnet Mover System, the OR Table Assembly and the Intra-operative Coil Kit.
The provided text is a 510(k) Summary of Safety and Effectiveness for the IMRIS Neuro II-SE Intra-Operative Magnetic Resonance Imaging System. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, this document does not contain the information required to populate the provided table or answer the specific questions about acceptance criteria and study details.
Here's a breakdown of why the information is missing:
- Type of Document: A 510(k) summary focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. It typically avoids detailed performance studies with acceptance criteria in the way a clinical trial or algorithm validation study would. Instead, it relies on comparisons to the established safety and effectiveness of the predicate.
- Nature of the Device: The Neuro II-SE is an MRI system. Its "performance" refers to image quality metrics (signal to noise, uniformity, geometric distortion, etc.) and safety aspects (magnetic field effects, RF heating, acoustic noise), which are generally established through engineering and physical bench testing against industry standards or predicate device specifications, not typically through clinical performance studies involving human readers and ground truth as described in your prompt.
- Lack of AI/Algorithm: The Neuro II-SE is a hardware device for imaging, not an AI, algorithm, or software-as-a-medical-device (SaMD) that would have performance metrics like sensitivity, specificity, or accuracy compared to a ground truth established by experts.
Therefore, I cannot extract the requested information from the provided text. The document states:
- "Laboratory testing has been completed to verify the equivalence to the Siemens Magnetom Espree System and to verify the safe and effective intra-operation of the Neuro II-SE."
- "The Neuro II-SE does not raise any new safety issues related to static magnetic field effects, changing magnetic field effects, RF heating or acoustic noise or effectiveness issues related to specification volume, signal to noise, image uniformity, and geometric distortion, slice profile, thickness and gap, or high contrast spatial resolution."
These statements indicate that specific tests were performed, but the details of those tests, including specific acceptance criteria, sample sizes, expert qualifications, or ground truth establishment, are not included in this summary.
In summary, based on the provided text, I cannot complete the table or answer the questions as they pertain to a different type of device validation study than what is presented here.
§ 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.