Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System

• K Number: K233542
• Device Name: Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System
• Manufacturer: Stryker Leibinger GmbH & Co. KG
• Date Cleared: 2024-03-14 ( 132 days)
• Product Code: OLO
• Regulation Number: 882.4560
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K223767 , K212194
• Predicate For: N/A

Intended Use

Ortho Guidance Precision Knee Software:
The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative quidance system to enable open computer-assisted surgerv. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Express Knee Software:
The Stryker quidance systems, with the Ortho Guidance Express Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Versatile Hip Software:
The Stryker guidance systems, with the Ortho Guidance Versatile Hip Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery.

The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.

The systems are indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate.

The system is indicated for the following surgical procedures:

• Total Hip Arthroplasty (THA)

• Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery

• Revisions

Q Guidance System:
The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. When used with the Ortho Guidance Precision Knee, Express Knee, or Versatile Hip Software, the Q Guidance System is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the femur, tibia, or long bone can be identified.

Device Description

The system is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. It allows for the localization of surgical instruments, and visualization of their position relative to patient specific anatomical landmark information, assisting the surgeon in performing the intervention at a high level of precision. The system uses active optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model. The computed model is based on an intraoperative anatomy survey of the pelvis and/or leg.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Stryker Q Guidance System and its associated software, based on the provided document:

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Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
System Accuracy (point)	Mean accuracy of 2 mm point displacement within the registration zone.
System Accuracy (angular)	Mean accuracy of 2° angular axis displacement within the registration zone.
Trueness for LED fiducial (mean Euclidean error)	$\le 150 \mu m$
Trueness for LED fiducial (95% percentile of Euclidean error)	$< 0.35 mm$
Trueness for reflective fiducial (mean Euclidean error)	$\le 150 \mu m$
Trueness for reflective fiducial (95% percentile of Euclidean error)	$\le 0.35 mm$
Trueness for single flashing LED fiducial	$LME_{mean} \le 70 \mu m + 70 \mu m/m * L, L \le 1.5 m$
Intended Use/User Needs	All requirements were met, and no new issues of safety or effectiveness were raised through validation with intended users in cadaver labs or simulated use tests.
Safety	Effectiveness of all risk controls determined in the device risk analysis was verified. No new questions of safety or effectiveness were raised.
General Requirements and Performance	All components met their design specifications. No new questions of safety or effectiveness were raised.
Software	Software verification and validation testing was conducted as required by IEC 62304 and FDA guidance on general principles of software validation, January 11, 2002. All requirements were met, and no new questions of safety or effectiveness were raised.
Biocompatibility	Not applicable, as the subject devices are not intended to be patient contacting.
Electrical Safety	Conformance to IEC 60601-1 Ed. 3.2 (2005 + AMD1:2012 + AMD2:2020) was verified.
Electromagnetic Compatibility	Conformance to IEC 60601-1-2 Ed. 4.1 (2014 + AMD1:2020), CISPR 11 Group 1 Class A was verified.
Shipping	Functionality of the devices after simulated shipping conditions was verified. No new questions of safety or effectiveness were raised.
Sterilization	Not applicable, as the subject devices are not intended to be sterilized.

The study that proves the device meets the acceptance criteria is a non-clinical design verification and validation testing campaign.

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Study Details

1. Sample size used for the test set and the data provenance:

   • The document does not specify a numerical sample size for the test set regarding the accuracy measurements. It mentions that testing was performed internally by the manufacturer.
   • Data Provenance: The data appears to be from internal testing conducted by Stryker Leibinger GmbH & Co. KG, located in Germany. The tests involved cadaver labs or simulated use, suggesting controlled laboratory environments rather than real-world patient data. The provenance is therefore prospective in a simulated environment.

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

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the numerical accuracy tests (e.g., fiducial trueness, system accuracy). These types of measurements are typically established using highly precise metrological equipment as the ground truth.
   • For "Intended Use/User Needs" testing, "intended users" were involved in cadaver labs or simulated use tests. However, the exact number and qualifications (e.g., specific surgical experience) of these "intended users" (e.g., surgeons) are not specified.

3. Adjudication method for the test set:

   • The document does not describe a formal adjudication method for the test set results. The accuracy metrics are quantitative measurements against an established standard. The user needs validation was presumably based on observation and feedback from the intended users.

4. 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 comparative effectiveness study was done or reported. The device is a surgical guidance system, not an AI diagnostic tool that assists human readers in interpreting medical images. The testing described focuses on the system's accuracy in tracking and guiding surgical instruments.

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

   • Yes, standalone performance was assessed. The accuracy measurements for fiducial trueness and system point/angular accuracy represent the direct, standalone performance of the tracking and guidance algorithms. The "Intended Use/User Needs" validation also assessed the integration and utility with a human user.

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

   • For the accuracy metrics (e.g., trueness for fiducials, system accuracy), the ground truth is implicitly defined by metrological standards and highly precise measurement systems, which assess the physical displacement and angulation of tracked objects.
   • For "Intended Use/User Needs," the ground truth involves user feedback and achievement of functional requirements observed in cadaver labs or simulated environments.

7. The sample size for the training set:

   • The document does not specify a numerical sample size for the training set. This is a navigation system primarily based on optical tracking and software for workflow and display, rather than a machine learning model that requires a discrete "training set" of patient data in the conventional sense. The "training" of such a system would involve extensive engineering, calibration, and iterative development based on design parameters and physical principles.

8. How the ground truth for the training set was established:

   • As this is not a machine learning-based device that would typically have a "training set" with explicit ground truth labels, the concept of ground truth for a training set in the AI sense does not directly apply here. Instead, during development and "training" of the underlying algorithms and hardware, ground truth is established through:
     • Physical calibration standards: For optical tracking, this involves precise optical benches and measurement devices to calibrate camera parameters, fiducial patterns, and spatial relationships.
     • Engineering specifications and simulations: Ground truth for software logic and mechanical tolerances is derived from engineering design requirements and validated through simulations.
     • Iterative testing and refinement: Early prototypes and software versions undergo extensive testing against known inputs and expected outputs to refine performance.

Summary

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March 14, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Stryker Leibinger GmbH & Co. KG Megan Guilbault Staff Regulatory Affairs Specialist Bötzinger Straße 41 Freiburg Baden-Wurttemberg, D-79111 Germany

Re: K233542

Trade/Device Name: Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 15, 2023 Received: December 15, 2023

Dear Megan Guilbault:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K233542 - Megan Guilbault

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shumaya Ali -S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K233542

Device Name

Ortho Guidance Precision Knee Software;

Ortho Guidance Express Knee Software;

Ortho Guidance Versatile Hip Software;

Q Guidance System

Indications for Use (Describe)

Ortho Guidance Precision Knee Software:

The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative quidance system to enable open computer-assisted surgerv. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Express Knee Software:

The Stryker quidance systems, with the Ortho Guidance Express Knee Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

Ortho Guidance Versatile Hip Software:

The Stryker guidance systems, with the Ortho Guidance Versatile Hip Software, are intended as a planning and intraoperative guidance system to enable open computer-assisted surgery.

The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified.

The systems are indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate.

The system is indicated for the following surgical procedures:

• Total Hip Arthroplasty (THA)

• Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery

• Revisions

Q Guidance System:

The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. When used with the Ortho Guidance Precision Knee, Express Knee, or Versatile Hip Software, the Q Guidance System is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the femur, tibia, or long bone can be identified.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Submitter Information

1.0 This Premarket Notification is submitted by:

Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 79111 Freiburg, Germany

2.0 Contact Information

Contact name:	Megan Guilbault
Cellular Telephone:	[phone]
Email:	[e-mail]
Date Prepared:	March 14, 2024

3.0 Device Name

Subject (Modified) Device Information
Trade/ Proprietary Name	Ortho Guidance Precision Knee SoftwareOrtho Guidance Express Knee SoftwareOrtho Guidance Versatile Hip SoftwareStryker Q Guidance System
Common Name	Stereotaxic Instruments
Classification	Class II
Classification Product Code	OLO
Classification Name	Orthopedic Stereotaxic Instrument
Classification Regulation	21 CFR 882.4560
Review Panel	Orthopedic

Table 1: Device Name

5.0 Predicate Devices

The following are the legally marketed predicate devices for the subject devices included in this Traditional 510(k). The primary predicate device is K223767.

Table 2: Predicate Device List
Subject Device	Predicate DeviceTrade Name	510(k)	ProductCode	Manufacturer
Ortho GuidancePrecision KneeSoftware	Ortho GuidancePrecision KneeSoftware	K223767	OLO	Stryker LeibingerGmbH & Co. KG
Ortho GuidanceExpress KneeSoftware	Ortho GuidanceExpress Knee Software	K223767	OLO	Stryker LeibingerGmbH & Co. KG
Ortho GuidanceVersatile HipSoftware	Ortho GuidanceVersatile Hip Software	K223767	OLO	Stryker LeibingerGmbH & Co. KG
Q Guidance System	Q Guidance System	K212194	HAW	Stryker LeibingerGmbH & Co. KG

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6.0 Device Description

The purpose of this Traditional 510(k) submission is to seek clearance for the addition of a Stryker guidance system to the indications of 3 Ortho Guidance software applications. The subject devices in scope of this submission are outlined in Table 1 with the predicate information in Table 2. The devices in scope of this submission, Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, and the O Guidance System work within an ecosystem with a host of other existing smart devices and accessories that will be demonstrated to be compatible with the subject devices but are not in scope of this submission.

The system is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. It allows for the localization of surgical instruments, and visualization of their position relative to patient specific anatomical landmark information, assisting the surgeon in performing the intervention at a high level of precision. The system uses active optical tracking technology to display to the surgeon the intraoperative location of navigated surgical instruments relative to a computed anatomical model. The computed model is based on an intraoperative anatomy survey of the pelvis and/or leg.

6.6 Indications for Use

6.6.1 Ortho Guidance Precision Knee Software

The Stryker guidance systems, with the Ortho Guidance Precision Knee Software, are intended as a planning and intraoperative guidance system to enable open computerassisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

6.6.2 Ortho Guidance Express Knee Software

The Stryker guidance systems, with the Ortho Guidance Express Knee Software, are intended as a planning and intraoperative guidance system to enable open computerassisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified. The systems are indicated for conditions of the knee joint in which the use of computer-assisted surgery may be appropriate.

6.6.3 Ortho Guidance Versatile Hip Software

The Stryker guidance systems, with the Ortho Guidance Versatile Hip Software, are intended as a planning and intraoperative guidance system to enable open computerassisted surgery. The systems can be used for intraoperative guidance where a reference to a rigid anatomical structure such as but not limited to the pelvis, or femur, can be identified. The systems are indicated for conditions of the hip joint in which the use of computer-assisted surgery may be appropriate.

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The system is indicated for the following surgical procedures:

• -Total Hip Arthroplasty (THA)
• Precisely positioning instruments, implants, and bony tissue during orthopaedic hip surgery
• Revisions -

6.6.4 Stryker Q Guidance System

The Q Guidance System is intended as an aid for precisely locating anatomical structures in open or percutaneous computer assisted surgery. When used with the Ortho Guidance Precision Knee, Express Knee, or Versatile Hip Software, the Q Guidance System is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate and where reference to a rigid anatomical structure such as the femur, tibia, or long bone can be identified.

6.7 Comparison of Technological Characteristics

A comparison of the technological characteristics of the subject devices included in the scope of this Traditional 510(k) is included in the tables below.

6.7.1 Technological Comparison between the Ortho Guidance Precision Knee Software and its predicate

The technological comparison between the subject device (Ortho Guidance Precision Knee Software) and the predicate device (Ortho Guidance Precision Knee Software) is included in Table 3 below. The predicate received clearance per 510(k) number K223767.

	PredicateSubject Device:Ortho Guidance Precision KneeSoftware	Predicate Device:Ortho Guidance Precision KneeSoftware (K223767)	Changes
Item
PlatformCompatibility	Stryker Ortho Q Guidance SystemStryker Q Guidance System	Stryker Ortho Q Guidance System	Added Stryker Q Guidance System
CompatibleOperatingSystem	Linux (Yocto Distro Version3.1, codename "dunfell").	Linux (Yocto Distro Version 3.1,codename "dunfell").	No change
Workflow Steps	Patient PreparationSystem Set-upPatient RegistrationAnalyze Initial AlignmentSize and Position ImplantResect BonesAnalyze Trial ImplantAnalyze Final Implant	Patient PreparationSystem Set-upPatient RegistrationAnalyze Initial AlignmentSize and Position ImplantResect BonesAnalyze Trial ImplantAnalyze Final Implant	No change
Localizationand TrackingTechnology	Infrared Optical Active Tracking:Infrared light emitted by diodes placed inspecific locations on tracked instrumentsis sensed by the navigation camera on theplatform, which allows for computationof the position and orientation of thetracked instruments.	Infrared Optical Active Tracking:Infrared light emitted by diodes placed inspecific locations on tracked instrumentsis sensed by the navigation camera on theplatform, which allows for computation ofthe position and orientation of the trackedinstruments.	No change

Table 3: Technological Comparison between the Ortho Guidance Precision Knee Software and its Predicate

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OperatingPrinciple	The software is installed on thecomputer that is part of theplatform The software displays the planneditems with navigational informationon a monitor	The software is installed on thecomputer that is part of the platform The software displays the planneditems with navigational informationon a monitor	No change
ControlMechanism	From outside the sterile surgicalfield, the software can be controlledusing the mouse, or touchscreen. From the sterile field, the softwarecan be controlled using the activeoptical instruments. The information of the software isdisplayed on a monitor. On the monitor, the blue highlightedbutton indicates the selectedfunction.	From outside the sterile surgical field, the software can be controlled usingthe mouse, or touchscreen. From the sterile field, the softwarecan be controlled using the activeoptical instruments. The information of the software isdisplayed on a monitor. On the monitor, the blue highlightedbutton indicates the selectedfunction.	No change
Intended UseEnvironment	Operating Room (OR)	Operating Room (OR)	No change
Intended Users	Trained clinical staff	Trained clinical staff.	No change
Graphical UserInterface(GUI)	Black style graphical user interface. Main Menu shows the workflowsteps that are available throughoutthe surgical procedures. Each screenof each workflow stepaccommodates a task instructionbelow the graphics.	Black style graphical user interface. Main Menu shows the workflowsteps that are available throughout thesurgical procedures. Each screen ofeach workflow step accommodates atask instruction below the graphics.	No change
User Interface	Surgeon's Monitor Small Touch Monitor Mouse Buttons on active opticalinstruments	Surgeon's Monitor Small Touch Monitor Mouse Buttons on active optical instruments	No change

6.7.2 Technological Comparison between the Ortho Guidance Express Knee Software and its predicate

The technological comparison between the subject device (Ortho Guidance Express Knee Software) and the predicate device (Ortho Guidance Express Knee Software) is included in Table 4 below. The predicate received clearance per 510(k) number K223767.

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Item	Subject Device:Ortho Guidance Express Knee Software	Predicate Device:Ortho Guidance Express KneeSoftware (K223767)	Changes
PlatformCompatibility	Stryker Ortho Q Guidance SystemStryker Q Guidance System	Stryker Ortho Q Guidance System	Added Stryker Q Guidance System
CompatibleOperatingSystem	Linux (Yocto Distro Version3.1, codename "dunfell").	Linux (Yocto Distro Version 3.1,codename "dunfell").	No change
Workflow Steps	Patient Preparation System Set-up Patient Registration Analyze Initial Alignment Size and Position Implant Resect Bones Analyze Trial Implant Analyze Final Implant	Patient Preparation System Set-up Patient Registration Analyze Initial Alignment Size and Position Implant Resect Bones Analyze Trial Implant Analyze Final Implant	No change
Localizationand TrackingTechnology	Infrared Optical Active Tracking:Infrared light emitted by diodes placed inspecific locations on tracked instrumentsis sensed by the navigation camera on theplatform, which allows for computationof the position and orientation of thetracked instruments.	Infrared Optical Active Tracking:Infrared light emitted by diodes placed inspecific locations on tracked instrumentsis sensed by the navigation camera on theplatform, which allows for computation ofthe position and orientation of the trackedinstruments.	No change
OperatingPrinciple	The software is installed on thecomputer that is part of theplatform The software displays the planneditems with navigational informationon a monitor	The software is installed on thecomputer that is part of the platform The software displays the planneditems with navigational informationon a monitor	No change
ControlMechanism	From outside the sterile surgicalfield, the software can be controlledusing the mouse, or touchscreen. From the sterile field, the softwarecan be controlled using the activeoptical instruments. The information of the software isdisplayed on a monitor. On the monitor, the blue highlightedbutton indicates the selectedfunction.	From outside the sterile surgical field,the software can be controlled usingthe mouse, or touchscreen. From the sterile field, the softwarecan be controlled using the activeoptical instruments. The information of the software isdisplayed on a monitor. On the monitor, the blue highlightedbutton indicates the selectedfunction.	No change
Intended UseEnvironment	Operating Room (OR)	Operating Room (OR)	No change
Intended Users	Trained clinical staff	Trained clinical staff	No change
Graphical UserInterface(GUI)	Black style graphical user interface. Main Menu shows the workflowsteps that are available throughoutthe surgical procedures. Each screenof each workflow stepaccommodates a task instructionbelow the graphics.	Black style graphical user interface. Main Menu shows the workflowsteps that are available throughout thesurgical procedures. Each screen ofeach workflow step accommodates atask instruction below the graphics.	No change
User Interface	Surgeon's Monitor Small Touch Monitor Mouse	Surgeon's Monitor Small Touch Monitor Mouse	No change

Table 4: Technological Comparison between the Ortho Guidance Express Knee Software and its
Predicate

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	Buttons on active optical instruments
Tracking SignalOutput	Visual and auditory	Visual and auditory	No change

6.7.3 Technological Comparison between the Ortho Guidance Versatile Hip Software and its predicate

The technological comparison between the subject device (Ortho Guidance Versatile Hip Software) and the predicate device (Ortho Guidance Versatile Hip Software) is included in Table 5 below. The predicate received clearance per 510(k) number K223767.

Table 5: Technological Comparison between the Ortho Guidance Versatile Hip Software and its Predicate

	Item	Subject Device:Ortho Guidance Versatile Hip Software	Predicate Device:Ortho Guidance Versatile HipSoftware (K223767)	Changes
	PlatformCompatibility	Stryker Ortho Q Guidance SystemStryker Q Guidance System	Stryker Ortho Q Guidance System	Added Stryker Q Guidance System
	OperatingSystem	Linux (Yocto Distro Version3.1, codename "dunfell").	Linux (Yocto Distro Version 3.1,codename "dunfell").	No change
	Workflow Steps	Patient Preparation System Set-up Patient Registration Analyze Initial Alignment Size and Position Implant Resect Bones Analyze Trial Implant Analyze Final Implant	Patient Preparation System Set-up Patient Registration Analyze Initial Alignment Size and Position Implant Resect Bones Analyze Trial Implant Analyze Final Implant	No change
	Localizationand TrackingTechnology	Infrared Optical Active Tracking:Infrared light emitted by diodes placed in specific locations on tracked instrumentsis sensed by the navigation camera on the platform, which allows for computationof the position and orientation of the tracked instruments.	Infrared Optical Active Tracking:Infrared light emitted by diodes placed in specific locations on tracked instrumentsis sensed by the navigation camera on the platform, which allows for computation ofthe position and orientation of the tracked instruments.	No change
	OperatingPrinciple	The software is installed on the computer that is part of the platform The software displays the planned items with navigational information on a monitor	The software is installed on the computer that is part of the platform The software displays the planned items with navigational information on a monitor	No change
	ControlMechanism	From outside the sterile surgical field, the software can be controlled using the mouse, or touchscreen. From the sterile field, the software can be controlled using the active optical instruments. The information of the software is displayed on a monitor. On the monitor, the blue highlighted button indicates the selected function	From outside the sterile surgical field, the software can be controlled using the mouse, or touchscreen. From the sterile field, the software can be controlled using the active optical instruments. The information of the software is displayed on a monitor. On the monitor, the blue highlighted button indicates the selected function	No change

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Intended UseEnvironment	Operating Room (OR)	Operating Room (OR)	No change
Intended Users	Trained clinical staff	Trained clinical staff.	No change
Graphical UserInterface(GUI)	Black style graphical user interface. Main Menu shows the workflow steps that are available throughout the surgical procedures. Each screen of each workflow step accommodates a task instruction below the graphics.	Black style graphical user interface. Main Menu shows the workflow steps that are available throughout the surgical procedures. Each screen of each workflow step accommodates a task instruction below the graphics.	No change
User Interface	Surgeon's Monitor Small Touch Monitor Mouse Buttons on active optical instruments	Surgeon's Monitor Small Touch Monitor Mouse Buttons on active optical instruments	No change
Tracking SignalOutput	Visual and auditory	Visual and auditory	No change

Technological Comparison between the Stryker Q Guidance System and its 6.7.4 predicate

The technological comparison between the subject device (Styker Q Guidance System) and the predicate device (Stryker Q Guidance System) is included in Table 6 below. The predicate received clearance per 510(k) number K212194.

Table 6-6: Technological Comparison between the Stryker Q Guidance System and Stryker Q Guidance System

Item	Subject Device:	Predicate Device:	Changes
	Stryker Q Guidance System	Stryker Q Guidance System (K212194)
OperatingPrinciple	The software is installed on the• computer that is part of theplatformImages are imported in• DICOM formatThe software displays images• and planned items withnavigational information on amonitor	The software is installed on the• computer that is part of theplatformImages are imported in DICOM• formatThe software displays images• and planned items withnavigational information on amonitor	Identical - the Ortho Guidance Softwareapplications are imageless and do use theimage import functionality that isavailable on the Q Guidance System.
Dimensions	Outer dimensions:• Length x Width x Height: 950 x 720 x 1950 mm• Weight: 265 kg	Outer dimensions:• Length x Width x Height: 950 x 720 x 1950 mm• Weight: 265 kg	No change
EnvironmentalConditions	Operation:• Temperature: 10°C – 30°C• Relative humidity: 30% – 75%• Atmospheric pressure: 70 kPa – 106 kPaTransportation:• Temperature: -10°C – 50°C• Relative humidity: 10% – 90%• Atmospheric pressure: 70 kPa – 106 kPaStorage:• Temperature: 10°C – 50°C• Relative humidity: 10% – 85%	Operation:• Temperature: 10°C – 30°C• Relative humidity: 30% – 75%• Atmospheric pressure: 70 kPa – 106 kPaTransportation:• Temperature: -10°C – 50°C• Relative humidity: 10% – 90%• Atmospheric pressure: 70 kPa – 106 kPaStorage:• Temperature: 10°C – 50°C• Relative humidity: 10% – 85%	No change
Atmospheric pressure: 70 kPa – 106 kPa	Atmospheric pressure: 70 kPa – 106 kPa	No change
WiFi ConnectivityTP-Link Archer T9UH, WiFi-USB - Adapter/Dongle	TP-Link Archer T9UH, WiFi-USB - Adapter/Dongle	No change
Cable GuardSpatula front mounted design	Spatula front mounted design	No change
Cart CastorsKeyboard and Mouse	Man & Machine Petite Mouse Medical grade mini mouse; silicon covered; can be disinfected ActiveKey, Medical grade keyboard; silicone covered; can be disinfected	Man & Machine Petite Mouse Medical grade mini mouse; silicon covered; can be disinfected ActiveKey, Medical grade keyboard; silicone covered; can be disinfected	No change
Application PC	Mainboard: MB-815-00A1E; Advantech Standard Server Board Intel Xeon 4109T Silver 8 Cores, 16 Threads Base Clock 2 GHz / Boost Clock 3 GHz 11 MB L3 Cache RAM 16 GB DDR4 2400MHz Memory: SQF SSD, M.2 480 GB for Operating System and Applications Seagate Enterprise 2.5" HDD, 2TB storage, 7000rpm Graphics Card: Leadtek RTX3060 12GB RAM Extension Cards: Magewell Pro Capture AIO 4k; digital 4k framegrabber Magewell Pro Capture AIO; mixed analog/digital framegrabber DVP-7013E; analog framegrabber 96NIC-1G4P-PE-IN2; Intel 4 Port Ethernet Card 968AD00483; USB to RS422 converter module	Mainboard: MB-815-00A1E; Advantech Standard Server Board Intel Xeon 4109T Silver 8 Cores, 16 Threads Base Clock 2 GHz / Boost Clock 3 GHz 11 MB L3 Cache RAM 16 GB DDR4 2400MHz Memory: Liteon SSD, M.2 256 GB for Operating System and Applications Seagate Enterprise 2.5" HDD, 2TB storage, 7000rpm Graphics Card: Leadtek Winfast RTX2070, 8GB RAM Extension Cards: Magewell Pro Capture AIO 4k; digital 4k framegrabber Magewell Pro Capture AIO; mixed analog/digital framegrabber DVP-7013E; analog framegrabber 96NIC-1G4P-PE-IN2; Intel 4 Port Ethernet Card 968AD00483; USB to RS422 converter module	No changeNo changeSimilarNo change
RFID ReaderOptical Drive	Omnikey 5127CK-Mini, 13.56 MHzLite-On Slim 8X SATA DVD+/-RW Dual Layer	Omnikey 5127CK-Mini, 13.56 MHzLite-On Slim 8X SATA DVD+/-RW Dual Layer	No change
RealTime PC	Mainboard AIMB-275G2-00A1E; Advantech Standard Mini ITX Board CPU Intel Core i7-7700T 4 Cores, 8 Threads Base clock 2.9 GHz / Boost clock 3.8 GHz 8 MB Smart Cache	Mainboard AIMB-275G2-00A1E; Advantech Standard Mini ITX Board CPU Intel Core i7-7700T 4 Cores, 8 Threads Base clock 2.9 GHz / Boost clock 3.8 GHz 8 MB Smart Cache	No change
	16 GB DDR4 2400MHzExtension Cards	16 GB DDR4 2400MHzExtension Cards
	Advantech DMS-IR06 dual port LAN card	Advantech DMS-IR06 dual port LAN card
Power Supply	Zippy DHG2-5600V, 600W, 48V-DC	Zippy DHG2-5600V, 600W, 48V-DC	No change
OperatingSystem	Linux (Yocto Distro Version3.1, codename "dunfell").	Linux (Yocto Distro Version3.1, codename "dunfell").	No change
Surgeon'sMonitor	Connect via HDMI interfaceMulti Touch functionalityAG80 anti-glare coating32"	Connect via HDMI interfaceMulti Touch functionalityAG80 anti-glare coating32"	No change
Small TouchMonitor	Connected via Display Portinterface (DP)15.6" Touch displayAG80 anti-glare coatingNo DVD-RW driveNo integrated RFID readerNo integrated power On/OffbuttonNo integrated LED indicatorsNo integrated virtual keyboard	Connected via Display Portinterface (DP)15.6" Touch displayAG80 anti-glare coatingNo DVD-RW driveNo integrated RFID readerNo integrated power On/OffbuttonNo integrated LED indicatorsNo integrated virtual keyboard	No change
PowerBox	XP-Power Custom DesignAC/DC power supplies (5V,24V, 48V)Battery with 9000mAhSystem can operate withoutbattery	XP-Power Custom DesignAC/DC power supplies (5V,24V, 48V)Battery with 9000mAhSystem can operate withoutbattery	No change
ConnectorPanel	USB3.0 port for data import(2) Low Latency Ethernet ports(3) Standard Ethernet portsAnalog S-Video inputAnalog NTSC/PAL VideoinputDigital DVI-D inputDigital 4K SDI Video inputDigital 4K HDMI Video inputEM Instrument Adapter Boxport (data signals / power)HDMI output for connectingexternal monitorsDisplay Port Video output	USB3.0 port for data import(2) Low Latency Ethernet ports(3) Standard Ethernet portsAnalog S-Video inputAnalog NTSC/PAL Video inputDigital DVI-D inputDigital 4K SDI Video inputDigital 4K HDMI Video inputEM Instrument Adapter Boxport (data signals / power)HDMI output for connectingexternal monitorsDisplay Port Video output	No change
OperatingPrinciple	The FP8000 Camera enables thecalculation of relative spatial relationshipof Stryker Navigated Instruments andTrackers which are equipped with IRfiducials by detecting the position of thelight center of each fiducial.	The FP8000 Camera enables thecalculation of relative spatial relationshipof Stryker Navigated Instruments andTrackers which are equipped with IRfiducials by detecting the position of thelight center of each fiducial.	No change
Fiducial Types	Single flashing LEDsParallel flashing LEDsContinuous illuminated LEDsReflecting infrared markerswhich reflect infrared lightoriginating from the FP8000	Single flashing LEDsParallel flashing LEDsContinuous illuminated LEDsReflecting infrared markerswhich reflect infrared lightoriginating from the FP8000	No change
	All fiducial types can be tracked inparallel, except for single flashing LEDs.	All fiducial types can be tracked inparallel, except for single flashing LEDs.	No change
InfraredSensors	Two 2D sensor arrays arranged at certainfixed distances to each other. Each ofthe two sensor arrays receives a signalfrom all illuminated fiducials. Thisallows for the calculation of the three-dimensional position of the fiducial fromthe two-dimensional sensors, commonlyknown for stereo camera systems.	Two 2D sensor arrays arranged at certainfixed distances to each other. Each of thetwo sensor arrays receives a signal fromall illuminated fiducials. This allows forthe calculation of the three-dimensionalposition of the fiducial from the two-dimensional sensors, commonly knownfor stereo camera systems.
InstrumentCommunication	Bi-direction IR communication	Bi-direction IR communication	No change
DataCommunication	Ethernet Link	Ethernet Link	No change
PoseCalculation	Two dimensional light centroids arecalculated based on each of the twosensor images.By triangulating the centroids, the 3Dposition of the illuminated fiducials canbe calculated. Multiple centroids can beacquired at once by illuminating thefiducials in parallel.By matching the 3D positions of thesingle fiducials to a known instrumentgeometry the correspondence betweenmeasured fiducial positions and fiducialson the instrument can be solved as wellas position and orientation of thenavigated instruments is calculated.	Two dimensional light centroids arecalculated based on each of the two sensorimages.By triangulating the centroids, the 3Dposition of the illuminated fiducials can becalculated. Multiple centroids can beacquired at once by illuminating thefiducials in parallel.By matching the 3D positions of the singlefiducials to a known instrument geometrythe correspondence between measuredfiducial positions and fiducials on theinstrument can be solved as well asposition and orientation of the navigatedinstruments is calculated.	No change
Sensor FrameRate	Up to 500 Hz, applicable to all fiducials	Up to 500 Hz, applicable to all fiducials	No change
Accuracy	Trueness for LED fiducial:mean Euclidean error <= $150 \mu m$ 95% percentile of Euclidean error < $0.35 mm$ Bigger working volumeTrueness for reflective fiducial:mean Euclidean error <= $150 \mu m$ 95% percentile of Euclidean error <= $0.35 mm$Trueness for single flashing LEDfiducial:$LME_{mean} \le 70 \mu m + 70 \mu m/m * L, L \le 1.5 m$	Trueness for LED fiducial:mean Euclidean error <= $150 \mu m$ 95% percentile of Euclidean error < $0.35 mm$ Bigger working volumeTrueness for reflective fiducial:mean Euclidean error <= $150 \mu m$ 95% percentile of Euclidean error <= $0.35 mm$Trueness for single flashing LED fiducial:$LME_{mean} \le 70 \mu m + 70 \mu m/m * L, L \le 1.5 m$	No change
Color Camera	Compact color video camera (LiveCam)is integrated in the FP8000 camera at acertain fixed position in relation to theinfrared sensors in such a way that theaxis of the LiveCam is pointing towardsthe surgical field.Native sensor resolution:3840 x 2160Full HD video stream resolution:1920 x 1080	Compact color video camera (LiveCam) is No changeintegrated in the FP8000 camera at acertain fixed position in relation to theinfrared sensors in such a way that the axisof the LiveCam is pointing towards thesurgical field.Native sensor resolution:3840 x 2160Full HD video stream resolution:1920 x 1080

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Image /page/14/Figure/1 description: The image shows a table comparing the specifications of a device, with two columns listing the same specifications and a third column indicating "No change". The specifications include video output via USB 3.0 (5 Gbps), infrared illumination to illuminate the working volume, a power of 24V, and a pyramidal working volume defined by dimensions X1 ≥ 500 mm, X2 ≥ 1400 mm, X3 ≥ 1860 mm, Y1 ≥ 500 mm, Y2 ≥ 1000 mm, Y3 ≥ 1560 mm, Z1 ≤ 700 mm, Z2 ≤ 1300 mm, and Z3 ≥ 2200 mm. There are also diagrams of the pyramidal working volume.

6.8 Summary of Non-Clinical Testing

The function and performance of the subject devices (i.e., Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, and the Q Guidance System) have been evaluated through non-clinical design verification and validation testing. The results of the evaluation tests demonstrate that the subject devices successfully meet the requirements of their intended use.

Additional testing was performed on the subject devices to ensure they met their design requirements. A summary of the testing and the results are included in the table below.

Item	Summary of Testing
Intended Use/ User Needs	The subject devices were validated with intended users in cadaver labsor simulated use tests to ensure the user needs and intended userequirements were met. All requirements were met and no new issuesof safety or effectiveness were raised.
Accuracy	The System is designed to work in the working space with a meanaccuracy of 2 mm point and 2° angular axis displacement within theregistration zone.
Safety	Verified the effectiveness of all risk controls determined in the devicerisk analysis. No new questions of safety or effectiveness were raised.
General Requirements andPerformance	Verified all components against their design specifications. Allrequirements were met and no new questions of safety or effectivenesswere raised.

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Software	Software verification and validation testing was conducted as requiredby IEC 62304 and FDA guidance on general principles of softwarevalidation, January 11, 2002. All requirements were met and no newquestions of safety or effectiveness were raised.
Biocompatibility	The subject devices are not intended to be patient contacting.
Electrical Safety	Verified conformance to IEC 60601-1 Ed. 3.2 (2005 + AMD1:2012 +AMD2:2020).
Electromagnetic Compatibility	Verified conformance to IEC 60601-1-2 Ed. 4.1 (2014 + AMD1:2020),CISPR 11 Group 1 Class A.
Shipping	The functionality of the devices after simulated shipping conditions wasverified. No new questions of safety or effectiveness were raised.
Sterilization	The subject devices are not intended to be sterilized.

6.9 Summary of Clinical Testing

No clinical testing was performed.

6.10 Conclusion

The subject devices, Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, and the Q Guidance System, perform as intended and are substantially equivalent to their respective predicate device with regard to intended use, design, principles of operation, technology, materials, and performance. No new questions of safety or effectiveness have been raised.

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).