Intended Use: The Stryker Navigation System - Cranial Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

Indications for Use: The system should be operated only by trained personnel such as surgeons and clinic staff. The Cranial Navigation system supports, but is not limited to, the following surgical procedures: ENT Procedures (Endoscopic Sinus Surgery (ESS), Intranasal procedures, Ear implant procedures), Neuro Procedures (Cranial biopsies, Puncture of abscesses, Craniotomies, Craniectomies, Resection of tumors and other lesions, Removal of foreign objects, Skull base procedures, Transnasal neurosurgical procedures, Transphenoidal pituitary surgery, Shunt placement, including pediatric shunt placement, Placement of electrodes for recording, stimulation and lesion generation, Craniofacial procedures, Skull reconstruction procedures, Orbital cavity reconstruction procedures).

Device Description

Stryker Navigation System - Cranial Module is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. The Stryker Navigation Cranial Module is a combination of the previously cleared Stryker Navigation System - Neuro Module and ENT Module with the addition of new features. The Cranial module will include automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.

AI/ML Overview

This 510(k) submission for the Stryker Navigation System - Cranial Module does not contain the information requested regarding acceptance criteria and a study to prove the device meets these criteria.

Instead, this document is a 510(k) summary and the FDA's clearance letter, focusing on establishing substantial equivalence to previously marketed predicate devices. It states that the device "does not raise any new safety and efficacy concerns" and is "substantially equivalent" to existing devices.

Therefore, I cannot provide the specific details you requested because they are not present in the provided text.

Here is what I can infer from the document regarding the justification for market clearance, which effectively substitutes the lack of a detailed performance study in this type of submission:

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

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The implicit acceptance criterion is "substantial equivalence" to predicate devices in terms of intended use, safety, and effectiveness.
Reported Device Performance: Not provided as a series of test results. The performance is implied to be similar to the predicate devices.

2. Sample size used for the test set and the data provenance

No specific test set or data provenance is mentioned as this is a substantial equivalence claim, not a de novo performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable as there is no specific test set or ground truth establishment described for this submission.

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

Not applicable.

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 MRMC study or AI assistance is mentioned. This is a navigation system, not an AI-driven diagnostic device.

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

Not applicable. This device is a planning and intraoperative guidance system for computer-assisted surgery, inherently designed for human-in-the-loop use.

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

Not applicable. Ground truth as typically understood for diagnostic or image analysis performance studies is not relevant here, as the device's efficacy is based on similarity to established devices.

8. The sample size for the training set

Not applicable. No new algorithm training is described.

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

Not applicable.

In summary: The provided document is a 510(k) (premarket notification) where the manufacturer, Stryker Instruments, is seeking clearance for their Navigation System - Cranial Module based on substantial equivalence to already legally marketed predicate devices. This type of submission generally does not require a new, extensive clinical trial or performance study against specific acceptance criteria if the new device is deemed sufficiently similar to existing ones. The "study" proving it meets acceptance criteria, in this context, is the comparison to predicate devices and the assertion that it "does not raise any new safety and efficacy concerns."

Summary

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4100 E. Milham Avenue
Kalamazoo, MI 49001 t: 269 323 7700 f: 800 965 6505
www.stryker.com

stryker

Instruments

K062640

510(k) Summary
Device Sponsor:	Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001(p) 269-323-7700(f) 269-324-5412	DEC 1 4 2006
Registration No.:	1811755
Trade Name:	Stryker Navigation System - Cranial Module
Common Name:	Navigation System
Classification Name:	Stereotaxic Instruments
Equivalent to:	K993239 Stryker Navigation - Neuro ModuleK002732 Stryker Navigation - ENT ModuleK050438 Medtronic StealthStation System
Device Description:	Stryker Navigation System - Cranial Module is part of the product series of theStryker Navigation System. The system comprises software for pre-operative surgicalplanning and supports computer assisted surgery based on a wireless optical trackinglocalization device for the use in navigated cranial surgery.The Stryker Navigation Cranial Module is a combination of the previously clearedStryker Navigation System - Neuro Module and ENT Module with the addition of newfeatures. The Cranial module will include automatic multi-modality correlation. Thesystem provides an easy-to-use work flow concept for image importation, FESS,Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor,vessels, etc. are supported.
Intended Use:	Stryker Navigation System - Cranial ModuleThe Stryker Navigation System -- Cranial Module is intended as a planning andintraoperative guidance system to enable open or percutaneous computer assistedsurgery. The system is indicated for any medical condition in which the use ofcomputer assisted planning and surgery may be appropriate. The system can be usedfor intra-operative guidance where a reference to a rigid anatomical structure can beidentified.
Indications for Use:	The system should be operated only by trained personnel such as orthopedic surgeonsand clinic staff. The Cranial Navigation system supports, but is not limited to, thefollowing surgical procedures:
	ENT Procedures
	Endoscopic Sinus Surgery (ESS)Intranasal procedures

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Ear implant procedures .

Neuro Procedures

. Cranial biopsies
Puncture of abscesses .
Craniotomies .
. Craniectomies
Resection of tumors and other lesions .
. Removal of foreign objects
. Skull base procedures
. Transnasal neurosurgical procedures
Transsphenoidal pituitary surgery .
Shunt placement, including pediatric shunt placement .
Placement of electrodes for recording, stimulation and lesion generation .
Craniofacial procedures .
Skull reconstruction procedures .
Orbital cavity reconstruction procedures .

Contraindications

Surgical situation where increasing surgical time may be detrimental to the patient.

Substantial Equivalence(SE) Rational:	The Stryker Navigation System - Cranial Module is equivalent in intended use, safety, and effectiveness to existing devices being marketed by Stryker and Medtronic.
Safety and Effectiveness:	The Stryker Navigation System - Cranial Module does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System - Cranial Module are substantially equivalent to these existing devices. They will be designed and manufactured in accordance with Stryker Leibinger's and Stryker Instrument's Quality Management System covered by QSR 21CFR 820.
Submitted by:	Becky Ditty

Substantial Equivalence(SE) Rational:

The Stryker Navigation System - Cranial Module is equivalent in intended use, safety, and effectiveness to existing devices being marketed by Stryker and Medtronic.

Safety and Effectiveness:

The Stryker Navigation System - Cranial Module does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System - Cranial Module are substantially equivalent to these existing devices. They will be designed and manufactured in accordance with Stryker Leibinger's and Stryker Instrument's Quality Management System covered by QSR 21CFR 820.

Submitted by:

Becky Ditty

Submitted by:	Becky Ditty
	Regulatory Affairs Representative
	Signature
Date submitted:	9/5/6

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling an abstract symbol in the center. The symbol appears to be an stylized representation of a human figure embracing or protecting another, possibly symbolizing care and support.

JAN 2 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Corporation % Ms. Becky Ditty Regulatory Affairs Representative Stryker Instruments Division 4100 E Milham Ave Kalamazoo, MI 49001

Re: K062640

Trade/Device Name: Stryker Navigation System - Cranial Module Regulation Number: 21 CFR § 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 14, 2006

Dear Ms. Ditty:

This letter corrects our substantially equivalent letter of December 14, 2006.

We have reviewed your Section 510(k) pre-market 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 (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.

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Page 2 - Ms. Becky Ditty

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.

This letter will allow you to continue marketing your device as described in your Section 510(k) pre-market 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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known):-K060313_____________________________________________________________________________________________________________________________________________

Device Name: Stryker Navigation System - Cranial Module

Intended Use

The Stryker Navigation System - Cranial Module is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intra-operative guidance where a reference to a rigid anatomical structure can be identified.

KD62640

Indications for Use

The system should be operated only by trained personnel such as surgeons and clinic staff. The Cranial Navigation system supports, but is not limited to, the following surgical procedures:

ENT Procedures

. Endoscopic Sinus Surgery (ESS)
. Intranasal procedures
Ear implant procedures .

Neuro Procedures

Cranial biopsies .
. Puncture of abscesses
Craniotomies .
Craniectomies .
Resection of tumors and other lesions .
Removal of foreign objects .
. Skull base procedures
. Transnasal neurosurgical procedures
Transphenoidal pituitary surgery .
. Shunt placement, including pediatric shunt placement
. Placement of electrodes for recording, stimulation and lesion generation
Craniofacial procedures .
. Skull reconstruction procedures
. Orbital cavity reconstruction procedures

Contraindications

Surgical situation where increasing surgical time may be detrimental to the patient. .

Prescription Use X(Part 21 CFR 801 Subpart D)	and/or	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)ce of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,

and Neurological Devices

510(k) Number	1062640
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Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).