The PoleStar N-20 is a Magnetic Resonance Diagnostic Device intended to produce transverse, sagittal, coronal, and oblique 2D and 3D images of the extremities and selected sections of the head. The images produced by the PoleStar N-20 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: extremities and selected sections of the head.

Nuclei excited: H-1

Diagnostic uses: T1, T2, T2* and density weighted imaging.

The PoleStar N-20 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 N-20 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 N-20 is a widely open and compact Intraoperative MRI unit intended to be used in a typical pre-existing operating room. The PoleStar N-20 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

This document is a 510(k) summary for the Odin Medical Technologies PoleStar N-20, an intraoperative MRI device. The primary claim for substantial equivalence is based on a comparison to the predicate device, Odin's PoleStar N-10. This filing does not describe a study to prove acceptance criteria for device performance. Instead, it focuses on demonstrating that the PoleStar N-20 is substantially equivalent to an existing device (the PoleStar N-10) based on similar technical specifications and identical intended use.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and statistical analysis is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide explicit "acceptance criteria" for performance that would typically be seen in a clinical validation study for a new diagnostic device. Instead, it offers a "Substantial Equivalence Comparison Table" that lists technical specifications of the new device (PoleStar N-20) against its predicate (PoleStar N-10). The "performance" in this context refers to these specifications matching or being comparable to the predicate.

Parameter	PoleStar N-10 (Predicate, K010850)	PoleStar N-20 (New Device)	Performance/Comparison
Clinical application	Extremities and selected sections of the head	Extremities and selected sections of the head	Identical
Magnet type	Permanent	Permanent	Identical
Field strength	0.12T	0.13T	Slight increase, deemed comparable
5 gauss fringe field (radial/axial, m)	1.5	2.2	Minor difference, likely considered acceptable for similar use
Shimming	Passive, active	Passive, active	Identical
Gradient subsystem Strength mT/m	25	22	Minor difference, likely considered acceptable
Gradient subsystem Rise time to 10mT/m msec	<1	<1	Identical
Computer system - CPU	Pentium 586	Pentium 586	Identical
Computer system - Memory size [MB]	64	64	Identical
Array processor	4xDSP C44 TI	4xDSP C44 TI	Identical
Array processor - Memory size [MB]	4000	4000	Identical
Storage media	Magnetic disk, floppy disk	Magnetic disk, floppy disk	Identical
Number of images stored	5000	5000	Identical
Imaging modes	Single, multislice, volume study	Single, multislice, volume study	Identical
Reconstruction time - single slice, sec	<3/slice	<3/slice	Identical
Reconstruction time - multislice, sec	<3/slice	<3/slice	Identical
Reconstruction time - volume sec	<20/volume	<20/volume	Identical
Cardiac gating (ECG/peripheral)	No	No	Identical
Respiratory gating	No	No	Identical
Angiography	Optional	Optional	Identical
Spectroscopy	No	No	Identical
Imaging - pulse sequence	Spin Echo, Fast Spin Echo, Gradient Echo, 2D 3D	Spin Echo, Fast Spin Echo, Gradient Echo, 2D 3D	Identical
Imaging - repetition time, msec	10-5000 increments of 1	10-5000 increments of 1	Identical
Imaging - echo time, msec	3-150	3-150	Identical
Imaging - inversion time, msec	N/A	N/A	Identical
Imaging - slice thickness, mm	2-10	2-10	Identical
Imaging - scan orientation	Transverse, coronal, sagittal, oblique	Transverse, coronal, sagittal, oblique	Identical
Imaging - measuring matrix	64x64 to 256x256 steps of 1 in phase encoding	64x64 to 256x256 steps of 1 in phase encoding	Identical
Imaging - display matrix	1024x768	1024x768	Identical
Imaging - pixel intensity	0-4095	0-4095	Identical
Surface coils	Knee, extremity, head	Knee, extremity, head	Identical
Bore diameter or WxH, cm	24.5x39	25.2x42	Minor difference, likely considered acceptable
Bore features	Open access to patient	Open access to patient	Identical
Cooling system type	Closed loop water cooling (Gradients only)	Closed loop water cooling (Gradients only)	Identical
Cryogen use	No	No	Identical
Magnet weight, kg	330	400	Minor difference, likely considered acceptable
HxWxD, cm	145x96x120	153x97x120	Minor difference, likely considered acceptable
Field Of View (FOV), cm	5-18	5-20	Minor difference, likely considered acceptable
Dicom 3.0 interface	Yes	Yes	Identical
Power requirements	3x208V, 16 Kva, <10000 BTU/hr A/C	3x208V, 15 Kva, <10000 BTU/hr A/C	Minor difference, likely considered acceptable

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. This document does not describe a clinical study with a test set of data. The substantial equivalence is based on technical specifications and intended use comparison.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. No ground truth establishment is described as there is no clinical test set in this filing. The filing mentions that "When interpreted by trained physicians, the MR images provide information that can be useful in determining a diagnosis," which refers to the eventual use of the device, not a study performed for this 510(k).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This document describes an MRI diagnostic device, not an AI or CAD system, and therefore, an MRMC study related to AI assistance would not be relevant or expected for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a hardware device (MRI scanner) which requires human operation and interpretation. The concept of standalone algorithm performance does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. As no clinical study or test set is described, no ground truth was established for this 510(k filing for the PoleStar N-20.**

8. The sample size for the training set:

Not Applicable. This document does not describe a machine learning or AI-based device that would require a training set.

9. How the ground truth for the training set was established:

Not Applicable. No training set or ground truth for a training set is described.

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of the PoleStar N-20 to its predicate, the PoleStar N-10, by comparing technical specifications and intended use. It does not include information about performance acceptance criteria validated through a clinical study with a test set, expert ground truth establishment, or AI-related metrics.

Summary

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SEP 1 2 2003

Image /page/0/Picture/2 description: The image shows the logo for Odin Medical Technologies. The logo features the word "ODIN" in bold, sans-serif font, with the words "Medical Technologies" in a smaller font size underneath. A stylized, incomplete circle or ring is positioned to the right of the word "ODIN", with a small, solid circle placed at the top of the ring, giving the impression of a planet with a ring system. The overall design is clean and modern.

Special 510(k) Summary of Safety and Effectiveness

The Following Special 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:Address:Phone:Fax:E-mail:	Einav Shlomovitz -- Quality and Regulatory DirectorP.O. Box 548, Yokneam Elit 20698, Israel+972-4-959-1010+972-4-959-1011einav@odin.co.il
Contact Person:	Einav Shlomovitz -Quality and Regulatory Director
Date:	August 4, 2003

807.92(a)(2) - Device Details:

Trade Name and Common Name:	PoleStar N-20 - Magnetic ResonanceDiagnostic Device
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 N-20 is comparable to Odin's PoleStar N-10

MedicalDevice Name	Applicant Name	510(k)Number	Classification
	PoleStar N-10 Odin Medical Thechnologies Ltd.	K010850	l Class Il device

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

807.92(a)(4) - Device Description:

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807.92(a)(5) - Device Intended Use:

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

. Anatomical regions:
Diagnostic uses:

extremities and selected sections of the head.

. Nuclei excited:
.

T1, T2, T2* and density weighted imaqing.

H-1

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Image /page/3/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is in bold, sans-serif font, with the "o" slightly larger than the other letters. Below "odin" is the phrase "Medical Technologies" in a smaller, italicized font. A circular design element is to the right of the word "odin".

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

Model	Odin	Odin
parameter	PoleStar N-10 (K010850)	PoleStar N-20
Clinical application	Extremities and selectedsections of the head	Extremities and selectedsections of the head
Magnet type	Permanent	Permanent
Field strength	0.12T	0.13T
5 gauss fringe field(radial/axial, m)	1.5	2.2
Shimming	Passive, active	Passive, active
Gradient subsystem
Strength mT/m	25	22
Rise time to 10mT/m	<1	<1
msec
Computer system
- CPU:	Pentium 586	Pentium 586
- Memory size [MB]	64	64
array processor	4xDSP C44 TI	4xDSP C44 TI
- Memory size [MB]	4000	4000
storage media	magnetic disk, floppy disk	magnetic disk, floppy disk
number of images stored	5000	5000
Imaging modes:
- single	Yes	Yes
- multislice	Yes	Yes
- volume study	Yes	Yes
- other	No	No
Reconstruction time:
- single slice, sec	<3/slice	<3/slice
- multislice, sec	<3/slice	<3/slice
- volume sec	<20/volume	<20/volume
Model	Odin	Odin
parameter	PoleStar N-10 (K010850)	PoleStar N-20
Cardiac gating(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	3-150
- 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:
- spine	No	No
- knee	Yes	Yes
- neck	No	No
- TMJ	No	No
- extremity	Yes	Yes
- head	Yes	Yes
- breast	No	No
- shoulder	No	No
- others	No	No
Model	Odin
parameter	PoleStar N-10 (K010850)	PoleStar N-20
Bore diameter or WxH, cm	24.5x39	25.2x42
Bore features	Open access to patient	Open access to patient
Cooling system type	Closed loop water cooling(Gradients only)	Closed loop water cooling(Gradients only).
Cryogen use	No	No
Magnet weight, kg	330	400
HxWxD, cm	145x96x120	153x97x120
Filed Of View (FOV),cm	5-18	5-20
Dicom 3.0 interface	Yes	Yes
Power requirements:
- line voltage, V	3x208 (3 phase)	3x208 (3 phase)
- Kva	16	15
- A/C, BTU/hr	<10000	<10000

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Image /page/4/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is in bold, black letters, with the words "Medical Technologies" in a smaller font below. There is a circular design to the right of the word "odin".

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Image /page/5/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is in large, bold, sans-serif font, with a stylized circle above the "i". Below "odin" are the words "Medical Technologies" in a smaller, sans-serif font. A partial circle is behind the word "odin".

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2003

Mr. Einav Shlomovitz Ouality and Regulatory Director Odin Medical Technologies Ltd. P.O. Box 548 Yokneam Elit, 20698 ISRAEL

Re: K032541

Trade/Device Name: PoleStar N-20 Regulatory Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH Dated: August 4, 2003 Received: August 18, 2003

Dear Mr. Shlomovitz:

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301).594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: PoleStar N-20

Indication For Use:

Anatomical regions: extremities and selected sections of

the head.

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 (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Daniel A. Bergman

(Division Sign-Off) Division of Reproductive, and Radiological Devices 510(k) Number

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.