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.

Device Description

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.

AI/ML Overview

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.

Summary

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MAR 1 6 2010

Traditional 510(k) Summary of Safety and Effectiveness

K092308

The Following Traditional 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).

807.92(a)(1) - Submitter Details:

Submitter name:	Yair Penias -Quality and Regulatory Manager
Address:	P.O. Box 548, Yokneam Elit 20692, ISRAEL
Phone:	+972-4-909-2306
Fax:	+972-4-959-1011
E-mail:	yair.penias@medtronic.com
Contact Person:	Yair Penias -Quality and Regulatory Manager
Date:	March 11, 2009

807.92(a)(2) - Device Details:

Trade Name and Common Name:	PoleStar N30 - Magnetic ResonanceDiagnostic Device, Also known as"PoleStar® N30 Surgical MRI System".
Classification:	21 CRF 892.1000 Magnetic ResonanceDiagnostic Device.
Class:	IIMRDD were reclassified by FDA fromClass III to Class II effective July 28,1998.
Product Code:	LNH – Magnetic Resonance ImagingSystem

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807.92(a)(3) - Predicate Devices:

The PoleStar N30 is comparable to:

MedicalDevice Name	Applicant Name	510(k)Number	Classification
PoleStar N-20	ODIN Technologies Ltd.	K032541	Class II device

Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.

807.92(a)(4) - Device Description:

Page 2 of 6 K092308

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807.92(a)(5) - Device Indication For Use:

The general purpose of the device as defined in 21 CFR 892.1000:

The PoleStar N30 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of sections of the head selected by the physician. The images produced by the PoleStar N30 reflect the spatial distribution of protons (Hydrogen Nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2*.

Anatomical regions: sections of the head selected by the physician. .
. Nuclei excited: H-1
T1, T2, T2* and density weighted imaging. Diagnostic uses: .

The PoleStar N30 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

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Image /page/3/Picture/0 description: The image shows the Medtronic logo. The logo consists of a circular symbol above the word "Medtronic". The symbol depicts a person in three different positions within the circle, suggesting movement or transformation. The word "Medtronic" is written in a bold, sans-serif font.

807.92(a){6) – Substantial Equivalence Comparison Table:

Model	Odin	Medtronic Navigation
parameter	PoleStar N-20 (K032541)	PoleStar (Model: N30)
Clinical application	Extremities and selectedsections of the head	sections of the headselected by the physician
Magnet type	Permanent	Permanent
Field strength	0.13T	0.13T
5 gauss fringe field(radial/axial, m)	2.2	2.2
Shimming	Passive, active	Passive, active
Gradient subsystem
Strength mT/m	22	23.5
Rise time to 10mT/m	<1	<0.15
msec
Computer system
- CPU:	Pentium 586	P4 2.8GHZ
- Memory Cache size [MB]	1	1
array processor	4xDSP C44 TI	4xDSP C44 TI
- Memory size [GB]	40	160
storage media	magnetic disk, floppy disk	magnetic disk, floppy disk
number of images stored	1,310,720	5,242,880
Imaging modes:
- single	Yes	Yes
- multislice	Yes	Yes
- volume study	Yes	Yes
- other	No	No
Reconstruction time:
- single slice, sec	<3/slice	<2/slice
- multislice, sec	<3/slice	<1/slice
- volume sec	<20/volume	<16/volume
Cardiac gating	No	No
Model	Odin	Medtronic Navigation
parameter	PoleStar N-20 (K032541)	PoleStar (Model: N30)
(ECG/peripheral)	No	No
Respiratory gating	No	No
Angiography	Optional	Optional
Spectroscopy	No	No
Imaging;
- pulse sequence	Spin Echo, Fast Spin Echo,Gradient Echo, 2D 3D	Spin Echo, Fast Spin Echo,Gradient Echo, 2D 3D
- repetition time, msec	10-5000 increments of 1	10-5000 increments of 1
- echo time, msec	3-150	2.5-150
- inversion time, msec	N/A	N/A
- slice thickness, mm	2-10	2-10
- scan orientation	Transverse, coronal,sagittal, oblique	Transverse, coronal,sagittal, oblique
- measuring matrix	64x64 to 256x256 steps of1 in phase encoding	64x64 to 256x256 steps of1 in phase encoding
- display matrix	1024x768	1024x768
- pixel intensity	0-4095	0-4095
Surface coils/Anatomicalregions:
- spine	No	No
- knee	Yes	No
- neck	No	No
- TMJ	No	No
- extremity	Yes	No
- head	Yes	Yes
- breast	No	No
- shoulder	No	No
- others	No	No
Bore diameter or WxH, cm	25.2x42	24.9 x42
Model parameter	OdinPoleStar N-20 (K032541)	Medtronic NavigationPoleStar (Model: N30)
Bore features	Open access to patient	Open access to patient
Cooling system type	Closed loop water cooling(Gradients only).	No
Cryogen use	No	No
Magnet weight, kg	400	330
HxWxD, cm	153x97x120	145x97x120
Filed Of View (FOV),cm	5-20	5-20
Dicom 3.0 interface	Yes	Yes
Power requirements:
- line voltage, V	3x208 (3 phase)	3x208 (3 phase)
- Kva	15	8
- A/C, BTU/hr	<10000	<10000

Page 4 of 6 K092308

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KO92308 Page 5 of 6

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and the state of the same of the same

KC92308 Page 6 of 6

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Yair Penias Quality and Regulatory Manager Medtronic Navigation Israel, Ltd. Kochav Yokneam Bldg, P.O. Box 548 Yokneam Elit, 20692 ISRAEL

MAR 1 3 2010

Re: K092308

Trade/Device Name: PoleStar N-30 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: February 18, 2010 Received: February 22, 2010

Dear Mr. Penias:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510/8) rremarket notification. The FDA finding of substantial equivalence of your device to a legally ronaketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollefree no (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Amiit J. Patel

Donald J. St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K092308

Device Name: PoleStar N-30

Indication For Use:

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.

(PLEASE DO NOT WRITE BELOW THE LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

. Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Eva

510K K092308

Dogecoin2

Page 1 of 1

Attachment B

Regulation Number and Section

§ 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.