The Stryker Navigation System – OrthoMap® 3D 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.

The system should be operated only by trained personnel such as surgeons and clinic staff.

The Stryker Navigation System - OrthoMap® 3D Module supports, but is not limited to, the following surgical procedures:

Orthopedic Oncology Procedures
Surgical Planning Procedures

Segmentation to define volumes of interest using correlated, multi-modality . image data, e.q. to assist outlining and visualizing bony structures such as aberrant pathology
Image based distance and anqular measurement tools, e.g. to define and maintain safety margins to outlined bony structures
Image based resection plane planning to define resections relative to identified structures, e.g. to support limb salvage surgery taking safety margins into account
Virtual screw placement planning in the image data with variable screw length, bead-length and diameter
Image based annotation point placement and visualization, e.q. to support repositioning of bony anatomic points during surgery

rgical Navigation Procedures

Intra-operative visualization of volume image data including visualization of pre-planned volumes of interest relative to the tracked instrument, supporting navigated excision of user-defined bony structures
Intra-operative visualization of resection planes relative to the tracked instrument on bony structures assisting bony resections
Intra-operative creation and visualization of annotation points, supporting recording of landmarks on bony anatomy, e.g. to assist oncology replacement prosthesis repositioning, leg length and rotation assessment or navigated implant placement
Navigated intra-operative screw placement based on pre-planned or intraoperative virtual screw definition

Device Description

The Stryker Navigation System - OrthoMap® 3D Module is part of the product series of the Stryker Navigation System. The system comprises software for surgical planning and computer assisted surgery based on a wireless optical tracking localization device for the use in navigated orthopedic oncology surgery.

AI/ML Overview

The provided text is a 510(k) summary for the Stryker Navigation System - OrthoMap® 3D Module, submitted to the FDA. It focuses on establishing substantial equivalence to existing predicate devices rather than directly presenting acceptance criteria and a detailed study proving the device meets them with specific performance metrics.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not present in the provided document.

Here's an attempt to answer based on the available information, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given 510(k) summary. The document focuses on establishing substantial equivalence by stating that the device "does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed." It does not present specific quantitative acceptance criteria or performance metrics for the OrthoMap® 3D Module itself.

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

This information is not provided in the 510(k) summary. There is no mention of a specific test set or data used for performance evaluation. The substantial equivalence argument relies on comparison to predicate devices and adherence to the manufacturer's Quality Management System.

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

This information is not provided in the 510(k) summary. No test set or ground truth establishment process by experts is described.

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

This information is not provided in the 510(k) summary. 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

There is no mention of an MRMC comparative effectiveness study in the provided document. The device is a navigation system for surgical planning and guidance, not an AI or imaging diagnostic tool that would typically involve human "readers" in the context of an MRMC study.

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

This information is not explicitly provided in the context of a formal study with specific results. The device is described as a "planning and intraoperative guidance system," implying a human-in-the-loop interaction. The 510(k) does not present standalone algorithm performance metrics.

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

This information is not provided in the 510(k) summary. No specific ground truth methodology is described as the document focuses on substantial equivalence rather than a de novo performance study.

8. The sample size for the training set

This information is not provided in the 510(k) summary. There is no mention of a training set as would be relevant for machine learning or AI algorithm development.

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

This information is not provided in the 510(k) summary. As there is no mention of a training set, the establishment of its ground truth is also not discussed.

Summary of the Study type presented (Substantial Equivalence):

The provided document describes a Substantial Equivalence submission. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, without necessarily requiring new clinical trials or detailed performance studies.

The study described (implicitly, through the 510(k) process) is a demonstration that:

The Stryker Navigation System - OrthoMap® 3D Module has the same intended use as the predicate devices (K062640 Cranial Module and K012380 Spine & Fluoroscopy Module).
It has similar technological characteristics (a wireless optical tracking localization device for computer-assisted surgery).
Any differences in technological characteristics do not raise new questions of safety or effectiveness.

The document states: "The Stryker Navigation System – OrthoMap® 3D Module does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Navigation System - OrthoMap® 3D Module is substantially equivalent to these existing devices." It also notes that the device will be designed and manufactured in accordance with Stryker Leibinger's Quality Management System covered by QSR 21CFR 820. This indicates an adherence to established quality and manufacturing control processes rather than reporting specific performance study results.

Summary

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KOr3009

FEB 1 9 2009

3.0 510(k) Summary
Device Trade Name:	Stryker Navigation System - OrthoMap® 3D Module
Common Name:	Navigation System
Product Code:	OLO
Classification Name:	Stereotaxic Instruments
Title 21 CFR:	§882.4560
Classification	ll
510(k) Contact Person:	Lilian EckertStryker Leibinger GmbH & Co. KGBötzinger Straße 41D-79111 FreiburgGermany(+49) 761 45 12 117email: lilian.eckert@stryker.com
Date Summary Prepared:	Feburary 9, 2009
Description:	The Stryker Navigation System - OrthoMap® 3D Module ispart of the product series of the Stryker Navigation System.The system comprises software for surgical planning andcomputer assisted surgery based on a wireless opticaltracking localization device for the use in navigatedorthopedic oncology surgery.
Intended Use:	The Stryker Navigation System - OrthoMap® 3D Module isintended as a planning and intraoperative guidance systemto enable open or percutaneous computer assisted surgery.The system is indicated for any medical condition in whichthe use of computer assisted planning and surgery may beappropriate. The system can be used for intra-operativeguidance where a reference to a rigid anatomical structurecan be identified.
Indications:	The system should be operated only by trained personnelsuch as surgeons and clinic staff.The Stryker Navigation System - OrthoMap® 3D Modulesupports, but is not limited to, the following surgicalprocedures:
	Orthopedic Oncology ProceduresSurgical Planning Procedures Segmentation to define volumes of interest using correlated, multi-modality image data, e.g. to assist outlining and visualizing bony structures such as aberrant pathologyImage based distance and angular measurement tools, e.g. to define and maintain safety margins to outlined

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	bony structuresImage based resection plane planning to defineresections relative to identified structures, e.g. to supportlimb salvage surgery taking safety margins into accountVirtual screw placement planning in the image data withvariable screw length, head-length and diameterImage based annotation point placement andvisualization, e.g. to support repositioning of bonyanatomic points during surgery
	Surgical Navigation Procedures
	Intra-operative visualization of volume image dataincluding visualization of pre-planned volumes of interestrelative to the tracked instrument, supporting navigatedexcision of user-defined bony structuresIntra-operative visualization of resection planes relativeto the tracked instrument on bony structures assistingbony resectionsIntra-operative creation and visualization of annotationpoints, supporting recording of landmarks on bonyanatomy, e.q. to assist oncology replacement prosthesisrepositioning, leg length and rotation assessment ornavigated implant placementNavigated intra-operative screw placement based onpre-planned or intra-operative virtual screw definition
Equivalent to:	K062640 Cranial ModuleK012380 Spine & Fluoroscopy Module
Substantial Equivalence:	The Stryker Navigation System – OrthoMap® 3D Moduledoes not raise any new safety and efficacy concerns whencompared to similar devices already legally marketed.Therefore, the Stryker Navigation System - OrthoMap® 3DModule is substantially equivalent to these existing devices.They will be designed and manufactured in accordance withStryker Leibinger's Quality Management System covered byQSR 21CFR 820.

1999 - 1999 - 1999

and the comments of the comments of

the country of the country of the county of

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Leibinger GmbH & Co.,KG % Ms. Lilian Eckert Regulatory Affairs Specialist Bötzinger Straße 41 D-79111 Freiburg Germany

Re: K083009

Trade/Device Name: Stryker Navigation System - OrthoMap® 3D Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO . Dated: February 10, 2009 Received: February 13, 2009

FEB 1 9 2009

Dear Ms. Eckert:

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 prodibitions againstansing and adulteration. Just

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Ms. Lilian Eckert

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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Potmarler, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse vents. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Arsistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David Krane

-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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Indications for Use Statement 2.0

510(K) Number (if known): K083009

Device Name: Stryker Navigation System = OrthoMap® 3D Module.

Intended Use

· The Stryker Navigation System – OrthoMap® 3D 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 Stryker Navigation System - OrthoMap® 3D Module supports, but is not limited to, the following surgical procedures:

Orthopedic Oncology Procedures

Surgical Planning Procedures

Segmentation to define volumes of interest using correlated, multi-modality . image data, e.q. to assist outlining and visualizing bony structures such as aberrant pathology
Image based distance and anqular measurement tools, e.g. to define and maintain safety margins to outlined bony structures
Image based resection plane planning to define resections relative to identified structures, e.g. to support limb salvage surgery taking safety margins into account
Virtual screw placement planning in the image data with variable screw length, bead-length and diameter
Image based annotation point placement and visualization, e.q. to support repositioning of bony anatomic points during surgery

rgical Navigation Procedures

Intra-operative visualization of volume image data including visualization of pre-planned volumes of interest relative to the tracked instrument, supporting navigated excision of user-defined bony structures
Intra-operative visualization of resection planes relative to the tracked instrument on bony structures assisting bony resections
Intra-operative creation and visualization of annotation points, supporting recording of landmarks on bony anatomy, e.g. to assist oncology replacement prosthesis repositioning, leg length and rotation assessment or navigated implant placement
Navigated intra-operative screw placement based on pre-planned or intraoperative virtual screw definition

Page 1 of 2

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and/or Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of 2

Nil RP Syler
Firman

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K083009

11:14 ...

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).