The IMRIS MR/X-ray Head Fixation Device System is an MR safe mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The MR/X-ray HFD is indicated for use during utilization of imaging modalities such as intraoperative MRI, CT imaging, and C-Arm X-ray angiography.

Device Description

The IMRIS MR/X-ray Head Fixation Device System (HFD) is an MR safe mechanical support system intended to be used in head, neck and spine surgery when rigid fixation is recruined for cranial stabilization. The IMRIS MR/X-ray HFD has been designed for use with intra-perative MR imaging, Xray Fluoroscopy and CT imaging modality.

The IMRIS MR/X-ray HFD and its accessories are designed to immobilize the head during surgical procedures and support patient in the prone, supine or lateral positions. The IMRIS MR/A Province ട് പ്രേം കേ ray HFD system can be used with either the operating room table or the angigraphy room table. The table adaptor is used to mount IMRIS MR/X-ray HFD on the table. The linkage system is used to mont the Skull Clamp to the table Adapter. The skull clamp (including 3 skull pins) is used to hold head and neck in a particular position during surgical procedures.

AI/ML Overview

The provided 510(k) summary for the IMRIS MR/X-ray HFD describes the device's substantial equivalence to predicate devices, focusing on its intended use, indications for use, and technological characteristics. Crucially, this document does not detail specific acceptance criteria for performance metrics (like accuracy, sensitivity, specificity, etc.) for an AI/algorithm-based device, nor does it describe a study proving the device meets such criteria in the context of AI. This is because the device being reviewed is a physical neurosurgical head holder, not an AI or algorithm.

Therefore, I cannot provide information regarding AI-specific acceptance criteria, reported performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

However, I can extract the relevant non-clinical data and testing performed for this physical device.

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

The document does not explicitly state numerical acceptance criteria with corresponding performance values in a table. Instead, it states that the device "passed the following tests and meets product specifications." The "reported device performance" is essentially that it successfully passed these tests.

Acceptance Criteria (Test Type)	Reported Device Performance
Usability requirements & workflow	Passed (meets product specifications)
Loading test	Passed (meets product specifications)
Third-party accessories compatibility test	Passed (meets product specifications)
MRI compatibility test (MR image artifacts test)	Passed (meets product specifications)
MRI compatibility test (MR heating test)	Passed (meets product specifications)
Radiolucency	Passed (meets product specifications)
Reliability test	Passed (meets product specifications)

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 describes bench testing, meaning the "test set" would refer to the physical device prototypes undergoing various engineering tests. The sample size of devices tested is not specified, but it would typically be a small number of units for such mechanical verification. There is no data provenance in terms of country of origin or retrospective/prospective as this applies to clinical data, not materials testing.

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. "Ground truth" in this context would refer to established engineering standards, material properties, and safety requirements. The "experts" would be the engineers and quality assurance personnel conducting and reviewing the tests, rather than medical experts establishing diagnostic ground truth. No specific number or qualifications are mentioned for this type of non-clinical testing.

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

Not applicable. This concept is relevant for interpreting ambiguous clinical data, not for objective engineering tests (e.g., a loading test either passes or fails based on predefined thresholds).

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 is a physical device, not an AI system.

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

Not applicable. This is a physical device, not an AI system.

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

For the biocompatibility of pins, the "ground truth" or verification was established by previous FDA clearances (K021604 and K072208) obtained by Integra LifeSciences Corporation, which manufactured the pins. For the design verification and validation (bench testing), the "ground truth" would be established engineering specifications, mechanical safety standards, MR compatibility standards, and usability requirements.

8. The sample size for the training set

Not applicable. This is a physical device.

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

Not applicable. This is a physical device.

Summary

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IMRIS

510(k) Summary for MR/X-ray HFD

510(k) SUMMARY FOR MR/X-ray HFD

MAR 2 3 2012

KII37

(As required by 21 CFR 807.92)

1. GENERAL INFORMATION

IMRIS Inc.

Address:

Establishment:

Registration Number:

Contact Person:

3003807210 Mr. Sanjay Shah QA and Regulatory Engineer Email: sshah@imris.com Phone: 1-204-480-7070 Fax: 1-204-480-7071

100-1370 Sony Place

Winnipeg, Manitoba Canada, R3T 1N5

Date of Summary Preparation:	March 6, 2012
Device Name / Trade name	IMRIS MR/X-ray Head Fixation Device
Classification Name:	Neurosurgical head holder (skull clamp)
Classification Panel:	Neurology
Classification (CFR section):	21 CFR 882.4460
Class:	Class II
Product Code:	HBL

2. PREDICATE DEVICES

The MR/X-ray HFD system is substantially equivalent to the following predicate medical devices.

NAME OF THE DEVICE	510(K)NUMBER	DATE OFCLEARANCE	MANUFACTURER
IMRIS Head Fixation Device (HFD100)	K103493	Nov 29, 2010	IMRIS Inc.
MAYFIELD® MR/X-Ray Skull Clamp	K081401	Oct 8, 2008	Integra LifeSciencescorporation
DORO® Radiolucent/MRI CompatibleCranial stabilization	K063494	May 21, 2007	Pro med instrumentsGmbH

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3. DEVICE DESCRIPTION

4. INDICATION FOR USE

The IMRIS MR/X-ray Head Fixation Device System is an MR safe mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The MRXray HFD is indicated for use during utilization of imaging modalities such as intraoperativer. MI, CT imaging, and C-Arm X-ray angiography.

	5. COMPARISON TO PREDICATE DEVICES
--	------------------------------------	--

Manufacturer	Integra LifeSciencesCorporation	Pro med instrumentsGmbH	IMRIS Inc.	IMRIS Inc.
FDA 510(k) #	K081401	K063494	K103493	Subject Device
Trade/Device Name	MAYFIELD® MR/X-RaySkull Clamp	DORO®Radiolucent/MRICompatible CranialStabilization andHalo Systems andaccessories	HFD100	MR/X-RAY HFD
Product Code	HBL	HBL	HBL	HBL
FDA Classification	21 CFR 882.4460	21 CFR 882.4460	21 CFR 882.4460	21 CFR 882.4460
Indication for use	The MAYFIELD® MR/X-Ray Skull clamp isplaced on the patient'sskull to hold their headand neck securely in aparticular position whenrigid fixation is desired.The clamp is indicatedfor use in open andpercutaneouscraniotomies as well asspinal surgery when rigidfixation is necessary. Inaddition, the clamp isindicated for use duringutilization of imagingmodalities such asintraoperative CT andMR imaging, C-Arm X-ray, and digitalsubtraction techniques.	The RadiolucentMRI CompatibleSkull ClampHeadrest Systemwith Skull PinsThe DORO®Radiolucent / MRICompatible SkullClamp HeadrestSystem with SkullPins are componentsof a mechanicalsupport systemwhich is used inhead and necksurgery when rigidskeletal fixation isrequired for cranialstabilization andwhen intra-operativeCT or MR Imaging isused.The Radiolucent /MRI CompatibleHorseshoe HeadrestSystemThe DORO®	The IMRIS HeadFixation DeviceSystem is an MRcompatiblemechanical supportsystem which isused in head, neckand spine surgerywhen rigid fixationis required forcranial stabilization.	The IMRIS MR/X-ray Head FixationDevice System isan MR safemechanical supportsystem which isused in head, neckand spine surgerywhen rigid fixationis required forcranial stabilization.The MR/X-ray HFDis indicated for useduring utilization ofimaging modalitiessuch asintraoperative MRI,CT imaging, and C-Arm X-rayangiography.
		Radiolucent / MRICompatibleHorseshoe HeadrestSystem arecomponentsof a mechanicalsupport systemwhich is used inhead and necksurgery when non-invasivehead support isrequired and whenintra-operative CT orMR Imaging is used.
CHARACTERISTIC	IntegraLifeSciencesCorporationMAYFIELD®MR/X-Ray SkullClamp(K081401)	Pro medinstrumentsGmbHDORO®Radiolucent/MRICompatibleCranialStabilization andHalo Systemsand accessories(K063494)	IMRIS Inc.IMRIS HFD100(K103493)	IMRIS Inc.IMRIS MR/X-RAY HFD(Currentsubmission)	COMPARISION
Skull Clamp	3-Pin Skull.clamp	3-Pin Skullclamp	3-Pin Skullclamp	3-Pin Skullclamp	Same
MRI systemCompatibility	MRI compatible	MRI compatible	MRI compatible	MRI safe	Same
Used withImaging Modality	IntraoperativeCT and MRimaging, C-ArmX-ray, and digitalsubtraction	Intra-operativeCT or MR	IntraoperativeMRI	IntraoperativeMRI, CTimaging, and C-Arm X-rayangiography.	Same as Integraand Pro med
Material	Compositematerials	NOVOTEXlaminated fabricwith phenolicresin(GRP) coloredwith BASANTOLblack X82 liquidand POM(Delrin), PEEKand Polyurethan	Titanium, Tefloncoatedfiberglassphenoliccomposites andAcetol (POM)	PEEK, Teflon,Cast Acrylic	Different
Mounting	Two pinmountingmechanism OnStandard ORTable	Two pinmountingmechanism OnStandard ORTable	Two pinmountingmechanism OnIMRIS designOR table orAngio table	Two pinmountingmechanism OnIMRIS designOR table orAngio table	Same asHFD100
Support load	20kg	12.5kg	20kg	20kg	Same
Pin force	80lb	80lb	80lb	80lb	Same
Application	GeneralneurosurgicalproceduresIntra-operativeneurosurgicalprocedures	GeneralneurosurgicalproceduresIntra-operativeneurosurgicalprocedures	GeneralneurosurgicalproceduresIntra-operativeneurosurgicalprocedures	GeneralneurosurgicalproceduresIntra-operativeneurosurgicalprocedures	GeneralneurosurgicalproceduresIntra-operativeneurosurgicalprocedures
CHARACTERISTIC	IntegraLifeSciencesCorporationMAYFIELD®MR/X-Ray SkullClamp(K081401)	Pro medinstrumentsGmbHDORO®Radiolucent/MRICompatibleCranialStabilization andHalo Systems	IMRIS Inc.IMRIS HFD100(K103493)	IMRIS Inc.IMRIS MR/X-RAY HFD(Currentsubmission)	COMPARISION
		and accessories(K063494)
Sterile Pins	MAYFIELD@RadiolucentSkull Pins A-2020	DORO®RadiolucentDisposableSingle-Use SkullPins of Yttried		MAYFIELD@RadiolucentSkull Pins A-2020	Same(Exactly thesame as IntegraLifeSciencesCorporationPins)
	(FDA 510(k) #K021604)	Zirconiumor Titanium areX-ray and MRIcompatible. MR-Safe
	MAYFIELD®TitaniumDisposable ChildSkull Pin A1119		MAYFIELD®TitaniumDisposable ChildSkull Pin A1119	MAYFIELD®TitaniumDisposable ChildSkull Pin A1119
	(FDA 510(k) #K072208)
	MAYFIELD®TitaniumDisposable AdultSkull Pin A1120		MAYFIELD®TitaniumDisposable AdultSkull Pin A1120	MAYFIELD®TitaniumDisposable AdultSkull Pin A1120
	(FDA 510(k) #K072208)
	MAYFIELD®Adult Skull Pin,Titanium A1121		MAYFIELD®Adult Skull Pin,Titanium A1121	MAYFIELD®Adult Skull Pin,Titanium A1121
	(FDA 510(k) #K072208)
	MAYFIELD®Child Skull Pin,Titanium A1122		MAYFIELD®Child Skull Pin,Titanium A1122	MAYFIELD®Child Skull Pin,Titanium A1122
	(FDA 510(k) #K072208)

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IMRIS

510(k) Summary for MR/X-ray HFD

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6. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE: (807.92 (A) (6))

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IMRIS

510(k) Summary for MR/X-ray HFD

KIIST

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K113748

7. SUMMARY OF NON-CLINICAL DATA

Biocompatibility of Pins:

The skull pins used in the MR/X-ray HFD are invasive. The biocompatibility of pins has been verified by Integra LifeSciences Corporation in K021604 and K072208.

There is no change made by IMRIS. Pins initially included are provided by Integra Life Sciences with their labeling. IMRIS does not relabel the pins. Pins are purchased from Integra LifeSciences Corporation directly.

Design Verification and Validation Test (Bench Testing)

The MR/X-ray HFD system passed the following tests and meets product specifications.

The tests include Usability requirements and workflow, Loading test, Third party accessories compatibility test, MRI compatibility test (MR image artifacts test, MR heating test), Radiolucency and Reliability test.

8. CONCLUSION

The MR/X-ray HFD has the same intended use and indications for use as the predicate devices. Performance data demonstrate safety and effectiveness of the MR/X-ray HFD with the new characteristics.

The IMRIS MR/X-ray HFD verification/validation results and performance/safety standard results show that the device is safe and effective and substantially equivalent to the currently available predicate devices, IMRIS HFD100, Integra LifeSciences MAYFIELD® MR/X-Ray Skull Clamp and Pro med instruments DORO® Radiolucent/MRI Compatible Cranial stabilization.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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. Sanjay Shah QA and Regulatory Engineer IMRIS Inc. 100-1370 Sony Place R3T 1N5 WINIPEG, MANITOBA CANADA

MAR 2 3 2012

Re: K113748

Trade/Device Name: IMRIS MR/X-ray Head Fixation Device Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: March 14, 2012 Received: March 15, 2012

Dear Mr. Shah:

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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Page 2

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(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 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

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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Indications for Use

510(k) Number (if known): K113748

Device Name: IMRIS MR/X-ray Head Fixation Device

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

_**_. (Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K113748

IMRIS 510(k) Premarket Notification IMRIS MR/X-ray HFD

Page 1 of 1

Regulation Number and Section

§ 882.4460 Neurosurgical head holder (skull clamp).

(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).