The PoleStar system is a magnetic resonance diagnostic device 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.

The StarShield V3 is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar system.

Device Description

The StarShieldV3 is an accessory of Odin's PoleStar Intraoperative Magnetic Resonance system. It is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent, required Elootromagnotion The RF Tent is a portable modular structure that consist of four principal components:

The foldable frame .
The cover .
The control unit .
The floor .

The RF Tent is not connected to the PoleStar gantry or the OR table.

AI/ML Overview

The provided text is a 510(k) summary for the StarShield V3 device, which is an accessory to an Intraoperative Magnetic Resonance system. The submission aims to demonstrate substantial equivalence to a predicate device (Odin's RF Tent). The primary function of the StarShield V3 is to reduce Electromagnetic Interference (EMI) during MRI image acquisition.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

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

The document does not explicitly present a table of "acceptance criteria" for the StarShield V3 in the typical sense of performance metrics with thresholds. Instead, it provides a "Substantial Equivalence Comparison Table" that lists parameters of the StarShield V3 and compares them to its predicate device, the RF Tent (K022157). The implicit acceptance criterion is that the StarShield V3 performs equivalently to the predicate device in terms of EMI reduction.

Parameter	Predicate Device (RF Tent - K022157)	StarShield V3	Acceptance/Performance
Application	To create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar system	Same	Equivalent
Materials - Frame	Aluminum alloy AlMg Si 0.5	Same	Equivalent
Materials - Cover	(Polyethylene Terephthalate) PET incorporating Cu+Ni, laminated with flame-retardant PVC.	Same	Equivalent
Dimensions - Length (Folded)	950 mm	Same	Equivalent
Dimensions - Length (Extended)	3500 mm	Same	Equivalent
Dimensions - Width/Base	1250 mm	Same	Equivalent
Dimensions - Maximum height	1650 mm	Same	Equivalent
Clearance between the RF tent and the operating table - Foot side (height)	200 mm	Same	Equivalent
Clearance between the RF tent and the operating table - Width (each side)	100 mm	Same	Equivalent
Clearance between the RF tent and the operating table - Head side (distance from scanner)	70 mm	Same	Equivalent
Average Attenuation	>40dB at 100 MHz	Same	Equivalent
Floor	Matte aluminum alloy sheet measuring 3.8 x 1.5 m	Same	Equivalent
Energy used	Pneumatic	Electric	Different (Minor)
Where Used	Operating Room	Same	Equivalent
Biocompatibility	Does not contact patient	Same	Equivalent

Note regarding "Acceptance/Performance": For most parameters, "Same" indicates the StarShield V3 meets the performance of the predicate by having identical specifications. For "Average Attenuation," the ">40dB at 100 MHz" is a specific performance metric that the StarShield V3 also claims as "Same," implying it meets or exceeds this level of attenuation. The only notable difference is "Energy used," which changed from pneumatic to electric, but the document implicitly suggests this change does not affect the substantial equivalence in terms of the primary function (EMI reduction).

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

The document does not provide information on a test set, its sample size, or data provenance. This 510(k) submission is for a physical medical device (an EMI shielding tent), not a software or diagnostic algorithm that would typically require a dataset to evaluate its performance. The "study" here is primarily a comparison of specifications and physical attributes to a predicate device.

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. As this is a physical device intended for EMI reduction, there is no "ground truth" derived from expert consensus on medical images or diagnoses. The performance is based on engineering specifications (e.g., attenuation levels).

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

Not applicable. There is no test set requiring expert adjudication.

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

Not applicable. This device is not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to its purpose.

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

Not applicable. The StarShield V3 is a physical accessory, not a standalone algorithm.

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

The "ground truth" for the StarShield V3's performance, as implied by the comparison table, is based on engineering specifications and measurements related to EMI attenuation. The predicate device (RF Tent) established a benchmark of ">40dB at 100 MHz" for average attenuation. The StarShield V3 is declared to have the "Same" attenuation, meaning it is expected to meet this engineering standard.

8. The sample size for the training set

Not applicable. This device is not a machine learning model, so there is no training set.

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

Not applicable. There is no training set for this device.

Summary

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MAR 1 8 2005

Image /page/0/Picture/1 description: The image shows the logo for Odin Medical Technologies. The word "odin" is written in a 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 curved line extends from the top right of the "n" in "odin" and arches over the word.

K050237

Special 510(k) Summary of Safety and Effectiveness

The Following Special 510(k) Summary of Safety and Effectiveness has been The Pollowing Special 510(k) Summary of Sales) and manes specified in 21 CFR § 807.92(a).

807.92(a)(1) - Submitter Details:

Submitter name:	Adi Ickowicz –Quality and Regulatory Director
Address:	P.O. Box 548, Yokneam Elit 20698, Israel
Phone:	+972-4-959-1010
Fax:	+972-4-959-1011
E-mail:	adi@odin.co.il
Contact Person:	Adi Ickowicz –Quality and Regulatory Director
Date:	January 8, 2005

807.92(a)(2) - Device Details:

	Trade Name and Common Name:
	StarShield V3
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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Image /page/1/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "ODIN" is in large, bold, black letters. Below it, in smaller letters, are the words "Medical Technologies". There is a curved line above and below the word "ODIN".

807.92(a)(3) - Predicate Devices:

The StarShield V3 is comparable to Odin's RF Tent

MedicalDevice Name	Applicant Name	510(k)Number	Classification
RF Tent	Odin Medical Thechnologies Ltd.	K022157	Class II device

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

807.92(a)(4) - Device Description:

The foldable frame .
The cover .
The control unit .
The floor .

The RF Tent is not connected to the PoleStar gantry or the OR table.

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Image /page/2/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "ODIN" is in large, bold, black letters. Below the word "ODIN" is the phrase "Medical Technologies" in a smaller font. There is a partial circle around the right side of the word "ODIN".

807.92(a)(5) – Device Intended Use:

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

The StarShield V3 is intended to create an area of substantially reduced Electromagnetic Interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar system.

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Image /page/3/Picture/0 description: The image shows the logo for Odin Medical Technologies. The word "odin" is written in large, bold, black letters. Below "odin" is the phrase "Medical Technologies" in a smaller font. There is a curved line above and to the right of the word "odin".

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

Model	Odin	Odin
parameter	RF Tent (K022157)	StarShield V3
Application	To create an area of substantiallyreduced ElectromagneticInterference (EMI) in the areaenclosed by the RF Tent duringimage acquisition by the PoleStarsystem	Same
Materials
Frame	Aluminum alloy AlMg Si 0.5	Same
Cover	(Polyethylene Terephthalate)PET incorporating Cu+Ni,laminated with flame-retardantPVC.	Same
Dimensions
Length (Folded)	950 mm	Same
Length (Extended)	3500	Same
Width/Base	1250 mm	Same
Maximum height	1650 mm	Same
Clearance between the RFtent and the operating table
Foot side (height)	200 mm	Same
Width (each side)	100 mm	Same
Head side (distancefrom scanner)	70 mm	Same
Average Attenuation	>40dB at 100 MHz	Same
Floor	Matte aluminum alloy sheetmeasuring 3.8 x 1.5 m	Same
Energy used	Pneumatic	Electric
Where Used	Operating Room	Same
Biocompatibility	Does not contact patient	Same

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MAR 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Adi Ickowicz Director of Regulatory Affairs Odin Medical Technologies Ltd. Kochav Yokneam Building P.O. Box 548 Yokneam Elite, 20698 (2) ISRAEL

Re: K050237 Trade/Device Name: StarShield V3 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance imaging system Regulatory Class: II Product Code: LNH Dated: January 31, 2005

Received: February 23, 2005

Dear Mr. Ickowicz:

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 the encessor the enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1778, increating 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 do including approvince or a controls provisions of the Act. The general controls provisions of the Act include reguirements 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 (Premarket n youval), it may be subject to such additional controls. Existing major regulations affecting your Apple ran 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 docs 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 rodotal barrers, 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) (2) 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter villing of substantial equivalence of your device of your device to a legally prematice notification: "Thesults 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 rryou desire specifice of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 77/ - 1 od may 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/industry/support/index.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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KOS 0237 510(k) Number (if known):

StarShield V3 Device Name:

Indication For Use:

The PoleStar system is a magnetic resonance diagnostic device intended for general diagnostic use to present images, which reflect the spatial distribution and/or magnetic diagnostic use to presont magges, and distribution of nuclei exhibiting nuclear magnetic resonance.

The StarShield V3 is intended to create an area of substantially reduced I he Starburnd VS is interference (EMI) in the area enclosed by the RF Tent during image acquisition by the PoleStar system.

(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) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Nancy C. Benson

(Division Sign-Division of Reproduc and Radiological Device 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.