(229 days)
The PoleStar N-30 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of sections of be bead selected by the physician. The images produced by the PoleStar N-30 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance.
The NMR properties that determine the image appearance are proton density, spinlattice relaxation time (T1), spin-spin relaxation time (T2) and T2*
Anatomical regions: sections of the head selected by the physician.
Nuclei excited: H-1
Diagnostic uses: T1, T2, T2* and density weighted imaging.
The PoleStar N-30 is intended to be used intraoperatively in a standard operating room. When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis.
The PoleStar N30 utilizes a permanent magnet to acquire 2D single-slice, multi slice, and 3d volume images. A wide variety of pulse sequences are provided to the operator, including spin echo, gradient echo, fast spin echo, and steady state free precession acquisitions. The PoleStar N30 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N30 can be moved within the room between procedures, from the operating table to its Magnet Storage Cabinet, thus allowing the operating room to be used for any type of surgery.
The provided document is a 510(k) Summary for the Medtronic PoleStar N30 Magnetic Resonance Diagnostic Device. It details substantial equivalence to a predicate device (PoleStar N-20) rather than presenting a performance study with acceptance criteria in the typical sense for an AI/ML device.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance studies is not available in this document because it describes an MRI device, not an AI/ML-driven diagnostic algorithm. The comparison is based on technical specifications and indications for use against a predicate device to demonstrate substantial equivalence, not a clinical performance trial proving the device meets specific quantitative acceptance criteria for diagnostic accuracy.
However, I can extract the relevant technical specifications that serve as a form of "acceptance criteria" for the device's capabilities and their reported performance in the context of demonstrating substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For an MRI device, "acceptance criteria" are generally framed around technical specifications and imaging capabilities, demonstrating that the new device performs at least as well as, or comparably to, the predicate device.
| Parameter | Predicate Device (PoleStar N-20) Performance | PoleStar N30 Performance (Reported) | Equivalence/Acceptance |
|---|---|---|---|
| Clinical application | Extremities and selected sections of the head | Sections of the head selected by the physician | Comparable (subset) |
| Magnet type | Permanent | Permanent | Equivalent |
| Field strength | 0.13T | 0.13T | Equivalent |
| 5 gauss fringe field (radial/axial, m) | 2.2 | 2.2 | Equivalent |
| Shimming | Passive, active | Passive, active | Equivalent |
| Gradient subsystem Strength mT/m | 22 | 23.5 | Comparable (improved) |
| Gradient subsystem Rise time to 10mT/m msec |
§ 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.