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510(k) Data Aggregation
(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 | <1 | <0.15 | Comparable (improved) |
| Computer system - CPU | Pentium 586 | P4 2.8GHZ | Comparable (improved) |
| Computer system - Memory Cache size [MB] | 1 | 1 | Equivalent |
| Computer system - array processor | 4xDSP C44 TI | 4xDSP C44 TI | Equivalent |
| Computer system - Memory size [GB] | 40 | 160 | Comparable (improved) |
| Storage media | Magnetic disk, floppy disk | Magnetic disk, floppy disk | Equivalent |
| Number of images stored | 1,310,720 | 5,242,880 | Comparable (improved) |
| Imaging modes | Single, multislice, volume study | Single, multislice, volume study | Equivalent |
| Reconstruction time - single slice, sec | <3/slice | <2/slice | Comparable (improved) |
| Reconstruction time - multislice, sec | <3/slice | <1/slice | Comparable (improved) |
| Reconstruction time - volume, sec | <20/volume | <16/volume | Comparable (improved) |
| Cardiac gating | No | No | Equivalent |
| Respiratory gating | No | No | Equivalent |
| Angiography | Optional | Optional | Equivalent |
| Spectroscopy | No | No | Equivalent |
| Imaging - pulse sequence | Spin Echo, Fast Spin Echo, Gradient Echo, 2D 3D | Spin Echo, Fast Spin Echo, Gradient Echo, 2D 3D | Equivalent |
| Imaging - repetition time, msec | 10-5000 increments of 1 | 10-5000 increments of 1 | Equivalent |
| Imaging - echo time, msec | 3-150 | 2.5-150 | Equivalent |
| Imaging - inversion time, msec | N/A | N/A | Equivalent |
| Imaging - slice thickness, mm | 2-10 | 2-10 | Equivalent |
| Imaging - scan orientation | Transverse, coronal, sagittal, oblique | Transverse, coronal, sagittal, oblique | Equivalent |
| Imaging - measuring matrix | 64x64 to 256x256 steps of 1 in phase encoding | 64x64 to 256x256 steps of 1 in phase encoding | Equivalent |
| Imaging - display matrix | 1024x768 | 1024x768 | Equivalent |
| Imaging - pixel intensity | 0-4095 | 0-4095 | Equivalent |
| Surface coils/Anatomical regions - head | Yes | Yes | Equivalent |
| Bore diameter or WxH, cm | 25.2x42 | 24.9 x42 | Comparable |
| Bore features | Open access to patient | Open access to patient | Equivalent |
| Cooling system type | Closed loop water cooling (Gradients only) | No | Different (less complex) |
| Cryogen use | No | No | Equivalent |
| Magnet weight, kg | 400 | 330 | Comparable (lighter) |
| HxWxD, cm | 153x97x120 | 145x97x120 | Comparable (smaller) |
| Field Of View (FOV), cm | 5-20 | 5-20 | Equivalent |
| Dicom 3.0 interface | Yes | Yes | Equivalent |
| Power requirements | 3x208 (3 phase), 15 Kva, <10000 BTU/hr | 3x208 (3 phase), 8 Kva, <10000 BTU/hr | Comparable (lower Kva) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This document is a 510(k) summary demonstrating substantial equivalence for an MRI device based on technical specifications and indications for use, not a clinical performance study with a test set of images or patient data. The comparison is against an existing predicate device's specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. As noted above, this is not a study involving expert assessment of images for ground truth. The "truth" here is the documented specifications and performance of the predicate device versus the proposed device.
4. Adjudication Method for the Test Set
Not applicable. There was no test set or adjudication process described for clinical performance in this document. Substantial equivalence is adjudicated by the FDA based on the comparison provided by the manufacturer.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is more common for diagnostic AI algorithms comparing human performance with and without AI assistance. This document is for an imaging device itself.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This document describes an MRI imaging system, not a standalone diagnostic algorithm. Performance is inherent to its imaging capabilities, not a separate algorithmic assessment.
7. Type of Ground Truth Used
The "ground truth" used for demonstrating substantial equivalence is the technical specifications and cleared indications for use of the predicate device (PoleStar N-20). The PoleStar N30's performance parameters are compared directly against these established benchmarks.
8. Sample Size for the Training Set
Not applicable. This document is for an MRI imaging device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device according to this document.
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