Intended Use:
The Stryker Navigation System - OrthoMap® 3D 1.1 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 intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system offers the following features and functions:
• Import of multi-modality image data
• Surgical planning, such as image manipulation and visualization and procedural planning
• Surgical navigation, such as manual and automatic registration and precise positioning of instruments and implants
Indications:
The system should be operated only by trained personnel such as surgeons and clinic staff.
The system can assist surgeons in the following, but not limited to, orthopedic surgical procedures:
• Orthopedic oncology procedures
• Cam type FAI (femoroacetabular impingement) surgery
• ACL (anterior cruciate ligament) reconstruction

Device Description

The Stryker Navigation System - OrthoMap® 3D 1.1 Module is part of the product series of the Stryker Navigation System. It is based on a wireless optical tracking localization device. The system comprises of hardware and software for surgical planning and computer assisted surgery. It supports orthopedic oncology procedures, cam type FAI (femoroacetabular impingement) surgery procedures and ACL (anterior cruciate ligament) reconstruction procedures.

AI/ML Overview

The provided text describes the Stryker Navigation System - OrthoMap® 3D 1.1 Module, a planning and intraoperative guidance system for computer-assisted orthopedic surgery.

However, the document does not explicitly state specific acceptance criteria in a quantitative or tabular format, nor does it provide a full study report with detailed numerical performance metrics for the device against such criteria. Instead, it offers a summary of verification and validation activities.

Based on the information provided, here's an analysis of the device's performance and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of quantitative acceptance criteria. It broadly states that "the specified acceptance criteria for system and clinical accuracy can be reached" but does not detail what these criteria were.

Acceptance Criteria (Quantitative)	Reported Device Performance
Not explicitly stated in the document. The document mentions that the data from cadaveric studies "revealed that the specified acceptance criteria for system and clinical accuracy can be reached," but the specific numerical criteria are not provided.	"the specified acceptance criteria for system and clinical accuracy can be reached for cam type FAI and ACL treatments."
Safety and Effectiveness: "No new types of issues of safety and effectiveness are introduced by using this device."	"The combination of the results of the bench testing, the cadaveric verification study, and the clinical confirmative trials demonstrate the safety and effectiveness of the system when used for the cam type FAI and ACL procedures."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "cadaveric verification studies" and "clinical confirmative trials."

Cadaveric Verification Studies (Test Set): Performed on "cadaveric" subjects. The document does not specify the exact sample size (number of cadavers or procedures). The provenance is not explicitly stated as a country, but "Stryker Leibinger GmbH & Co. KG" is based in Germany. The studies were likely prospective in nature for verification.
Clinical Confirmative Trials (Test Set): The system "has been used clinically for cam type FAI treatments." The sample size and location (country) are not specified. These trials were likely prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts or their qualifications used to establish ground truth for the test sets (cadaveric or clinical). It mentions the system "should be operated only by trained personnel such as surgeons and clinic staff," implying expert involvement during clinical use, but not explicitly in establishing ground truth for validation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth in the cadaveric or clinical test sets.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The focus is on the device's performance, not specifically on comparing human readers with and without AI assistance. The device is a "guidance system" for surgery, implying human-in-the-loop, but not in a diagnostic reading context.

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

The device is described as a "planning and intraoperative guidance system" and assists surgeons. This implies a human-in-the-loop system, not a standalone algorithm without human intervention. The performance studies focus on the overall system (hardware and software) in conjunction with clinical use.

7. The Type of Ground Truth Used

For the cadaveric verification studies, the ground truth for "system and clinical accuracy" would likely be established through precise measurements using gold-standard techniques (e.g., coordinate measuring machines, optical tracking, direct anatomical measurements) compared against the system's output.
For the clinical confirmative trials, the ground truth would typically be based on intraoperative assessments by experienced surgeons, post-operative imaging, and potentially patient outcomes, confirming the safe and effective use of the system.
However, the specific methods are not detailed in the summary.

8. The Sample Size for the Training Set

The document does not specify any sample size for a training set. This device is a navigation system for surgery, not an AI/ML diagnostic algorithm that typically undergoes a distinct "training" phase with labeled data in the sense of deep learning or machine learning models. Its algorithms are likely based on established geometric and image processing principles, refined and verified through the described bench and cadaveric testing.

9. How the Ground Truth for the Training Set was Established

As there's no mention of a distinct "training set" in the context of an AI/ML model, this question is not applicable based on the provided information. The software is part of a "Navigation System" that performs planning and guidance based on image data and anatomical structures. Its "ground truth" for development would stem from engineering principles, mathematical models, and knowledge of anatomy and surgical procedures, validated through the performance testing described.

Summary

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K093206

510(k) Summary

।

510(k) Owner:	Stryker Leibinger GmbH & Co. KG - NavigationBötzinger Straße 41D-79111 FreiburgGermany(p) (+49) 761 45 12 117(f) (+49) 761 45 12 49 117
	AUG 04 2010
Registration No .:	3007582679
Contact Person:	Lilian Eckertemail: lilian.eckert@stryker.comSenior Regulatory Affairs Specialist
Date Summary Prepared:	July 29, 2010
Device Trade Name:	Stryker Navigation System - OrthoMap® 3D 1.1 Module
Common Name:	Navigation System
Product Code:	OLO
Classification Name:	Orthopedic Stereotaxic Instrument
Title 21 CFR:	§882.4560
Device Description:	The Stryker Navigation System - OrthoMap® 3D 1.1 Module is part of theproduct series of the Stryker Navigation System. It is based on a wirelessoptical tracking localization device. The system comprises of hardware andsoftware for surgical planning and computer assisted surgery. It supportsorthopedic oncology procedures, cam type FAI (femoroacetabularimpingement) surgery procedures and ACL (anterior cruciate ligament)reconstruction procedures.
Indications for Use:	Intended Use:The Stryker Navigation System - OrthoMap® 3D 1.1 Module is intended as aplanning and intraoperative guidance system to enable open orpercutaneous computer assisted surgery. The system is indicated for anymedical condition in which the use of computer assisted planning andsurgery may be appropriate. The system can be used for intraoperativeguidance where a reference to a rigid anatomical structure can be identified.The system offers the following features and functions:• Import of multi-modality image data• Surgical planning, such as image manipulation and visualization andprocedural planning• Surgical navigation, such as manual and automatic registration andprecise positioning of instruments and implantsIndications:The system should be operated only by trained personnel such as surgeonsand clinic staff.The system can assist surgeons in the following, but not limited to,orthopedic surgical procedures:• Orthopedic oncology procedures• Cam type FAI (femoroacetabular impingement) surgery• ACL (anterior cruciate ligament) reconstruction

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Substantial Equivalence:

Performance Testing

(Bench):

(Clinical):

The Stryker Navigation System - OrthoMap® 3D 1.1 Module is substantially equivalent in design, intended use and performance to the following predicate devices:

Stryker Navigation System OrthoMap® 3D Module (K083009) .
Stryker Navigation System Cranial Module (K062640) .
BrainLAB VectorVision® ACL (K042512) .
� Medtronic Orthopaedic Trauma Application (K050651)

The following verification and validation activities were performed:

Bench testing according to Stryker Navigation's procedures for product . design and development. It includes software code reviews, component, functional, integration, safety and accuracy testing. It shows that the product meets the requirements. Also, it shows that no software anomalies impacting safety and effectiveness are known.
- Cadaveric verification studies evaluating the overall system and clinical . accuracy when used for FAI or ACL treatment. The analysis of the data revealed that the specified acceptance criteria for system and clinical accuracy can be reached for cam type FAI and ACL treatments.
Performance Testing . Clinical confirmative trials: The system has been used clinically for cam type FAI treatments. The trials confirm the results of bench testing and the cadaveric verification study. They also show that the system can be used safely and effectively in the clinical environment.
- Comprehensive literature review discussing the safety and effectiveness . during usage of other navigation devices for FAI and ACL procedures. The review shows that other devices using equivalent characteristics and functionality can be used safely and effectively for cam type FAI and ACL procedures.
The combination of the results of the bench testing, the cadaveric verification Conclusion: study, and the clinical confirmative trials demonstrate the safety and effectiveness of the system when used for the cam type FAI and ACL procedures. No new types of issues of safety and effectiveness are introduced by using this device.

The literature review and the comparison to the predicate devices show that the device makes use of equivalent technological characteristics and functionality and is intended for equivalent surgical procedures as compared to the predicate devices.

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Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized symbol that appears to be three overlapping, curved lines, possibly representing a stylized human figure or a symbol related to health and human services. The image is in black and white and has a slightly distressed or aged appearance.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

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

AUG 0 4 2010

Re: K093206

Trade/Device Name: Stryker Navigation System - OrthoMap® 3D 1.1 Module Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: July 29, 2010 Received: August 02, 2010

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 prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Lilian Eckert

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark N Milliken

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known): K093206

AUG 0 4 2010

Device Name: Stryker Navigation System - OrthoMap® 3D 1.1 Module

Intended Use:

The Stryker Navigation System - OrthoMap 3D 1.1 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 intraoperative guidance where a reference to a rigid anatomical structure can be identified. The system offers the following features and functions:

Import of multi-modality image data .
Surgical planning, such as image manipulation and visualization and procedural planning .
Surgical navigation, such as manual and automatic registration and precise. positioning of . instruments and implants

Indications:

The system should be operated only by trained personnel such as surgeons and clinic staff. The system can assist surgeons in the following, but not limited to, orthopedic surgical procedures:

Orthopedic oncology procedures .
Cam type FAI (femoroacetabular impingement) surgery
ACL (anterior cruciate ligament) reconstruction

Over-The-Counter Use Prescription Use × - AND/OR . (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 1 of 1

Nillfogle for mkm

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093206

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).