The Stryker OrthoMap Precision Knee system, which is comprised of the OrthoMap Precision Knee 5.0 Software and a platform of the NAV3i platform family, is intended as a planning and intraoperative guidance system to enable open or percutaneous image guided surgery.

The system can be used for intraoperative guidance where a rigid anatomical structure can be identified. The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.

Device Description

The Stryker OrthoMap Precision Knee system is intended to be used as a planning and intraoperative guidance system to enable open or percutaneous image guided knee surgery. The system uses wireless optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model of the patient's leg (femur and tibia). The computed model is based on an intra-operative anatomy survey of the leg. The system consists of a Stryker surgical software application (software), which runs on a platform, consisting of a Stryker computer, a navigation camera, an IO-Tablet and a monitor. The Stryker surgical software application interfaces with smart instruments (e.g. patient trackers, instrument trackers or pointers) and several accessories enabling the tracking of surgical instruments.

The Stryker OrthoMap Precision Knee 5.0 software is compatible with the NAV31 Platform Family. The NAV3i platform family is a family of platforms that, when used with a surgical software application, displays patient specific images and/or patient specific anatomical landmark information and tracks the position and movement of surgical instruments in relation to a target anatomical site on a patient. The NAV3i platform family consists of the following three platforms that have been previously cleared independently or with other Stryker surgical software applications:

Stryker NAV3 Platform
Stryker NAV3i Platform ●
Stryker NAVSuite3 Kit

The platforms consist of the following components:

Stryker computer
Navigation camera ●
IO-Tablet ●
Monitor
Mobile cart (if applicable) ●

AI/ML Overview

This document is a 510(k) summary for the Stryker OrthoMap Precision Knee system. It does not describe a study that validates AI performance, but rather outlines the performance criteria and testing for a computer-assisted surgical guidance system. Therefore, some of the requested information regarding AI-specific studies (e.g., MRMC studies, training set details) will not be available.

Here's an analysis of the provided text for the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Specification)	Reported Device Performance
Electrical Safety	Device conforms to ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (FDA Rec# 19-4).
Electromagnetic Compatibility (EMC)	Device conforms to IEC 60601-1-2:2007: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (FDA Rec#19-1).
Software Verification and Validation	Conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered a "MAJOR" level of concern.
Accuracy of Localization and Tracking Technology	Verified using ASTM Standard F2554-10. (Specific performance result not explicitly stated here, but implied as meeting the general system accuracy below).
System Accuracy (Translational Error)	Mean translational error of < 2 mm.
System Accuracy (Rotational Error)	Mean rotational error of < 1°.
Clinical Workflow Functionality and Compatibility	All system components (application, computer platform, and accessories) are compatible, verified through simulated complete total knee arthroplasty procedures using Sawbones.
Functional Requirements	All functional requirements are fulfilled (verified by functional testing).
Safety (Risk Control Effectiveness)	Effectiveness of all risk controls (determined in device risk analysis and platform risk analyses) verified by safety testing.

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

Test Set Sample Size: The document does not specify a distinct "test set" in the context of an AI-driven system. Instead, performance testing (bench testing) was conducted.
- Accuracy Testing: Involved tests according to ASTM Standard F2554-10. The sample size for this specific test is not provided.
- System Accuracy Testing: Used a "mechanical leg mimicking the patient's anatomy." The number of mechanical legs or repetitions is not specified.
- Clinical Workflow Testing: Involved "simulated complete total knee arthroplasty procedures using Sawbones." The number of Sawbones or simulated procedures is not specified.
Data Provenance: The data is from bench testing and simulated procedures, not human patient data. Therefore, country of origin or retrospective/prospective status is not applicable in the traditional sense. It is all laboratory-generated data.

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

This information is not applicable. The device is a surgical guidance system relying on physical measurements and mechanical models, not interpretation of medical images or data by human experts for ground truth in this context. The "ground truth" for accuracy testing would be the known, precise measurements and angles of the mechanical testing setups.

4. Adjudication Method for the Test Set

Not applicable as there is no human interpretation or subjective assessment of a test set that would require 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

No, an MRMC comparative effectiveness study was not done. This document pertains to a computer-assisted surgical navigation system, not an AI-driven image interpretation or diagnostic tool that would typically involve human readers. The focus is on the accuracy and functionality of the guidance system itself.

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

Yes, in essence, standalone performance was evaluated. The "Performance Testing - Bench" section describes tests aimed at verifying the accuracy and functionality of the system (localization, tracking, software algorithms) in a controlled environment, mimicking patient anatomy. This is an evaluation of the algorithm's performance independent of real-time human surgical input, demonstrating its intrinsic accuracy and function.

7. The Type of Ground Truth Used

The ground truth used for the bench testing was based on:
- Standardized Test Procedures: For ASTM accuracy testing, the ground truth would be defined by the standardized procedure itself and the known parameters of the test setup.
- Mechanical Models and Known Parameters: For system accuracy testing and clinical workflow testing, the ground truth was derived from the precise, known measurements and configurations of the "mechanical leg mimicking the patient's anatomy" and "Sawbones." Essentially, these represent controlled and measurable physical realities within the bench test environment.

8. The Sample Size for the Training Set

This information is not provided because the document describes a computer-assisted surgical guidance system, not a device developed using machine learning that requires a "training set" in the conventional sense. The "software" here likely refers to deterministic algorithms and established mathematical models for navigation and guidance, rather than a learned AI model.

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

Not applicable, as there is no mention of a "training set" in the context of machine learning. The software's development would likely be based on engineering principles, anatomical models, and mathematical algorithms, not an iterative training process with labeled data.

Summary

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

October 12, 2016

Stryker Leibinger Gmbh & Co. Kg % Calley Herzog Senior Consultant Biologics Consulting Group, Inc. 400 North Washington Street, Suite 100 Alexandria, Virginia 22314

Re: K162341

Trade/Device Name: Stryker OrthoMap Precision Knee System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: August 18, 2016 Received: August 22, 2016

Dear Ms. Herzog:

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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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

Enclosure

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Indications for Use

510(k) Number (if known) K162341

Device Name Stryker OrthoMap Precision Knee system

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
✖ Prescription Use (Part 21 CFR 801 Subpart D)	❏ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Stryker OrthoMap Precision Knee system is provided below.

Device Common Name:	Orthopedic Stereotaxic Instrument
Device Trade Name:	Stryker OrthoMap Precision Knee system
Applicant:	Stryker Leibinger GmbH & Co. KGBoetzinger Strasse 41D-79111 Freiburg, GermanyPhone number: +49-761-45120Fax number: +49-761-45120
Contact:	Bjoern LampartStryker Leibinger GmbH & Co. KGBoetzinger Strasse 41D-79111 Freiburg, GermanyP +49 761 4512 3991C +49 160 97870607F +49 761 4512 49 3991bjoern.lampart@stryker.com
Prepared by:	Calley HerzogSenior ConsultantBiologics Consulting Group, Inc.cherzog@biologicsconsulting.comPhone: 720-883-3633
Date Prepared:	August 18, 2016
Classification Regulation:	§882.4560 - Stereotaxic Instrument
Panel:	Orthopedic
Product Code:	OLO - Orthopedic Stereotaxic Instrument
Predicate Device:	K153240 - Stryker OrthoMap Express Knee system

Indication for Use:

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The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.

The system is indicated for conditions of the knee joint in which the use of computer assisted surgery may be appropriate.

Device Description:

Stryker NAV3 Platform
Stryker NAV3i Platform ●
Stryker NAVSuite3 Kit

The platforms consist of the following components:

Stryker computer
Navigation camera ●
IO-Tablet ●
Monitor
Mobile cart (if applicable) ●

Performance Data:

The following performance data were provided in support of the substantial equivalence decision:

Electrical Safety and Electromagnetic Compatibility (EMC) Testing

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Electrical safety and EMC testing were conducted on the subject device in accordance with the following standards:

ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and ● A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (FDA Rec# 19-4)
. IEC 60601-1-2:2007: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (FDA Rec#19-1)

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "MAJOR" level of concern.

Performance Testing - Bench

The following design verification activities have been performed to ensure the correct functionality of the system as it has been specified:

ASTM accuracy testing verifying the accuracy performance of the localization and . tracking technology using the standardized test procedure according to ASTM Standard F2554-10.
. System accuracy testing verifying the specified accuracy of ± 2 mm and ± 1° using a mechanical leg mimicking the patient's anatomy.
. Clinical workflow testing verifying that all system components (application, computer platform and accessories) are compatible. Complete total knee arthroplasty procedures are simulated using Sawbones mimicking the patient's anatomy.
Functional testing to ensure that all functional requirements are fulfilled.
. Safety testing verifying the effectiveness of all risk controls determined in the device risk analysis and in the risk analyses of the platforms.

This strategy ensures the verification of the accuracy, system integration, software algorithms, system functionality, and correct implementation of the risk control measures. All tests have been successfully completed.

Animal Study

No animal studies were performed to support substantial equivalence.

Clinical Studies

No clinical studies were performed to support substantial equivalence.

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Substantial Equivalence Rationale:

The intended uses of the subject and predicate devices are similar. The systems are intended as planning and intraoperative guidance systems to enable open or percutaneous computer assisted surgery. Minor modifications were made to the indication for use statement to provide clarification, but do not change the meaning of the indication for use statement.

Both the subject device and the primary predicate device use the same main system components, use similar modes of operation, and use the same localization and tracking technology. Also, both systems use similar accessories (Smart Instruments, Patient Tracker Fixation, Navigated Manual Instruments and other accessories).

The technological characteristics of the subject and predicate device are equivalent. None of the changes alter the operating principle, the control mechanism, the localization and tracking technology, the main system components or the system accuracy performance. The workflow, user interaction, the software architecture and the software features are similar. As demonstrated by the performance testing described above, the subject device continues to meet the same accuracy specifications as the predicate device. Therefore, the differences in technological characteristics to do not raise new questions of safety and effectiveness.

In conclusion, the Stryker OrthoMap Precision Knee system can be found substantially equivalent to the OrthoMap Express Knee system (K153240).

The device comparison table below provides a comparison of the technological characteristics of the subject device to the primary predicate device.

	Subject DeviceStryker OrthoMap Precision Knee System	Predicate Device - K153240Stryker OrthoMap Express Knee system
510(k) Number	Under review	K153240
Clearance Date	Under review	July 7, 2016
Device Name	Stryker Navigation OrthoMap Precision Knee5.0 Navigation System	Stryker Navigation OrthoMap ExpressKnee 2.0 Navigation System
RegulationNumber	§882.4560 - Stereotaxic Instrument	§882.4560 - Stereotaxic Instrument
Product Code	OLO - Orthopedic Stereotaxic Instrument	OLO - Orthopedic Stereotaxic Instrument
Product Class	II	II
Localizationand Trackingtechnology	Infrared optical active sensing technology:Infrared light emitted by diodes placed in aknown fashion on navigated surgicalinstruments is sensed by a camera array(navigation camera) on the computer platform,thus allowing for computation of the spatialinformation.	Infrared optical active sensing technology:Infrared light emitted by diodes placed in aknown fashion on navigated surgicalinstruments is sensed by a camera array(navigation camera) on the computerplatform, thus allowing for computation ofthe spatial information.
	Subject DeviceStryker OrthoMap Precision Knee System	Predicate Device – K153240Stryker OrthoMap Express Knee system
Main SystemComponents	Computer PlatformOrthoMap Precision Knee 5.0 SoftwareSmart InstrumentsPatient Tracker FixationNavigated Manual InstrumentsInstrument Battery, Trays	Computer PlatformOrthoMap Express Knee 2.0 SoftwareSmart InstrumentsPatient Tracker FixationNavigated Manual InstrumentsInstrument Battery, Trays
CompatiblePlatforms	NAV3i Computer Platform Family:Stryker NAV3 PlatformStryker NAV3i PlatformStryker NAVSuite3 Kit	NAV3i Computer Platform Family:Stryker NAV3 PlatformStryker NAV3i PlatformStryker NAVSuite3 Kit
Registrationand NavigationWork Flow	Patient PreparationSystem SetupPatient Registration (femur and tibia)Analyze Initial AlignmentSize and Position ImplantResect BonesAnalyze Trial ImplantAnalyze Final Implant	Patient PreparationSystem SetupPatient Registration (femur)Navigation (femur)Patient Registration (tibia)Navigation (tibia)
SystemAccuracy	The system enables the determination of themechanical axes of the leg as well as cut andcomponent alignment with a meantranslational error of $<$ 2 mm and a meanrotational error of $<$ 1°.	The system enables the determination of themechanical axes of the leg as well as cutand component alignment with a meantranslational error of $<$ 2 mm and a meanrotational error of $<$ 1°.
Accessories:Patient /InstrumentTrackers	Patient/Instrument TrackersUniversal Tracker Tibia/Pelvic Tracker Femoral Tracker nGenius Universal Tracker nGenius Tibial Tracker nGenius Femur Tracker Hip Femur Tracker Hip Tibia/Pelvis TrackerPointers Pointer, Knee Navigation Ortho Grip Knee Pointer Pointer, Straight	Femur Trackers / Tibia TrackersUniversal Tracker Tibia/Pelvic Tracker Femoral Tracker nGenius Tibial Tracker nGenius Femur Tracker nGenius Femur Tracker Hip Femur Tracker Hip Tibia/Pelvis TrackerPointers Pointer, Knee Navigation Ortho Grip Knee Pointer Pointer, Straight
Accessories:Patient TrackerFixation	OrthoLock with OrthoLock Navigation Pin orOrthoLock EX-PinsAnchoring Pins and Insertion Tool	ASM Fixation Plate
	Subject DeviceStryker OrthoMap Precision Knee System	Predicate Device – K153240Stryker OrthoMap Express Knee system
Accessories:NavigatedManualInstruments	Dedicated Mini Jig (which consists of): Adjustment Component Tracker Adapter Mini Cutting Guide Mini Fixation Plate MIS Jig (which consists of): Navigated MIS Jig-A Navigated MIS Jig-B Tracker Adapter Plane Probes (Resection Plan Probes and aPosterior Plane Probe)	Dedicated Mini Jig (which consists of): Adjustment Component Tracker Adapter Mini Cutting Guide ASM Resection Plane Probe
Screwdrivers	ScrewdriverUniversal Joint Screwdriver	ScrewdriverUniversal Joint Screwdriver

Device Comparison Table:

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Substantial Equivalence Conclusion:

Based on the comparison of intended use and technological characteristics, the device is similar to the predicate device. The hardware and software verification and validation testing demonstrate that the subject device meets its performance specifications and will perform as intended in the specified use conditions and that any differences between the subject device and predicate device do not raise new questions of safety and effectiveness. Therefore, the subject device can be found substantially equivalent to the predicate device.

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).