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

Q: Who is the manufacturer of Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System?

Stryker Leibinger GmbH & Co KG filed the 510(k) submission for Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System (K223767).

Q: What is the FDA product code for Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

Q: What is the regulatory pathway for Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System?

Stryker OrthoMap Precision Knee 5.0 Software (K162341); Stryker OrthoMap Express Knee 2.0 Software (K153240); Stryker OrthoMap Versatile Hip 2.0 Software (K162937); Stryker Q Guidance System (K220593).

Q: Who can help prepare an FDA 510(k) submission like Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K223767 · Stryker Leibinger GmbH & Co KG · OLO · Feb 13, 2023 · Neurology

Device Facts

Record ID	K223767
Device Name	Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System
Applicant	Stryker Leibinger GmbH & Co KG
Product Code	OLO · Neurology
Decision Date	Feb 13, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

Ortho Guidance Precision Knee Software: The Stryker Ortho Q Guidance System, with the Ortho Guidance Precision Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. 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. Ortho Guidance Express Knee Software: The Stryker Ortho Q Guidance System, with the Ortho Guidance Express Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. 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. Ortho Guidance Versatile Hip Software: The Stryker Ortho Q Guidance System, with the Ortho Guidance Versatile Hip Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system 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 system is 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 Ortho Q Guidance System: The Stryker Ortho Q Guidance System is intended as an aid for precisely locating anatomical structures in open computer assisted surgery. The 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 skull, vertebra, or long bone can be identified.

Device Story

System provides planning and intraoperative guidance for orthopedic surgery. Uses active optical tracking (FP8000 camera) to detect infrared light from LEDs on surgical instruments; computes spatial position/orientation relative to patient anatomy. Input: intraoperative anatomy survey (pelvis/leg). Output: visual/auditory navigation data on monitors. Used in OR by trained clinical staff. Assists surgeons in precise instrument/implant positioning; improves surgical accuracy; reduces potential for malalignment.

Clinical Evidence

No clinical data. Bench testing only, including cadaver labs and simulated use testing. Accuracy verified with mean point displacement of 1.32 mm and angular displacement of 0.73 degrees.

Technological Characteristics

Active optical tracking system using infrared LEDs. Linux-based (Yocto) dual PC architecture. Connectivity via Ethernet, USB, and video interfaces. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2. Non-patient contacting; no sterilization required.

Indications for Use

Indicated for patients requiring computer-assisted surgery for knee or hip joint conditions, including total hip arthroplasty and revisions. Applicable where rigid anatomical structures (e.g., pelvis, femur, skull, vertebra, long bone) can be identified for reference.

Regulatory Classification

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.

Predicate Devices

Stryker OrthoMap Precision Knee 5.0 Software (K162341)
Stryker OrthoMap Express Knee 2.0 Software (K153240)
Stryker OrthoMap Versatile Hip 2.0 Software (K162937)
Stryker Q Guidance System (K220593)

Related Devices

K233542 — Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System · Stryker Leibinger GmbH & Co KG · Mar 14, 2024
K162341 — Stryker OrthoMap Precision Knee system · Stryker Leibinger GmbH & Co KG · Oct 12, 2016
K050615 — STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 · Stryker Instruments · Apr 21, 2005
K093206 — ORTHOMAP 3D 1.1 MODULE · Stryker Corp. · Aug 4, 2010
K171525 — Intellijoint HIP Generation 2B System · Intellijoint Surgical, Inc. · Oct 30, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ February 13, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. Stryker Leibinger GmbH & Co. KG Megan Guilbault Senior Regulatory Affairs Specialist Bötzinger Straße 41 Freiburg Baden-Wurttemberg, D-79111 Germany Re: K223767 Trade/Device Name: Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho O Guidance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 15, 2022 Received: December 15, 2022 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 (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 located 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. 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 {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jesse Muir -S For: 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 Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K223767 #### Device Name Ortho Guidance Precision Knee Software: Ortho Guidance Express Knee Software: Ortho Guidance Versatile Hip Software: Ortho O Guidance System ### Indications for Use (Describe) Ortho Guidance Precision Knee Software: The Stryker Ortho Q Guidance System, with the Ortho Guidance Precision Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. 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. Ortho Guidance Express Knee Software: TThe Stryker Ortho Q Guidance System, with the Ortho Guidance Express Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. 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. Ortho Guidance Versatile Hip Software: The Stryker Ortho Q Guidance System, with the Ortho Guidance Versatile Hip Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. The system 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 system is 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 Ortho Q Guidance System: The Stryker Ortho Q Guidance System is intended as an aid for precisely locating anatomical structures in open computer assisted surgery. The 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 skull, vertebra, or long bone can be identified. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 6.0 Submitter Information ## 6.1 This Premarket Notification is submitted by: Stryker Leibinger GmbH & Co. KG Bötzinger Straße 41 79111 Freiburg, Germany ## 6.2 Contact Information | Contact name: | Megan Guilbault | |---------------------|-----------------------------| | Cellular Telephone: | (401) 241-6152 | | Email: | megan.guilbault@stryker.com | | Date Prepared: | December 15, 2022 | ## 6.3 Device Name | Table 6-1: Device Name | | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Subject (Modified) Device Information | | | Trade/ Proprietary Name | Ortho Guidance Precision Knee Software Ortho Guidance Express Knee Software Ortho Guidance Versatile Hip Software Stryker Ortho 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 | #### Predicate Devices 6.4 The following are the legally marketed predicate devices for the subject devices included in this Traditional 510(k): | Subject Device | Predicate Device Trade Name | 510(k) | Product Code | Manufacturer | |----------------------------------------------|----------------------------------------------------------------|---------|-----------------|------------------------------------| | Ortho Guidance Precision Knee Software | Stryker OrthoMap Precision Knee 5.0 Software Application | K162341 | OLO | Stryker Leibinger GmbH & Co. KG | | Ortho Guidance Express Knee Software | Stryker OrthoMap Express Knee 2.0 Software Application | K153240 | OLO | Stryker Leibinger GmbH & Co. KG | | Ortho Guidance Versatile Hip Software | Stryker OrthoMap Versatile Hip 2.0 Software Application | K162937 | OLO | Stryker Leibinger GmbH & Co. KG | | Ortho Q Guidance System | Stryker Q Guidance System | K220593 | OLO | Stryker Leibinger GmbH & Co. KG | | Table 6-2: Predicate Device List | | | | | |----------------------------------|--|--|--|--| |----------------------------------|--|--|--|--| {5}------------------------------------------------ #### ર્ભ રહ્યું હતું. સ Device Description The purpose of this Traditional 510(k) submission is to seek clearance for 3 new software applications and 1 new guidance system. The applications have been created for functionality on the new guidance system in scope of this submission. The subject devices in scope of this submission are outlined in Table 6-1 with the predicate information in Table 6-2. The devices in scope of this submission, Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, and the Ortho Q 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 Ortho Guidance Precision Knee Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Precision Knee System. The Ortho Guidance Express Knee Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Express Knee System. The Ortho Guidance Versatile Hip Software used with Stryker Ortho Q Guidance System is referred as Ortho Guidance Versatile Hip System. 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 Ortho O Guidance System, with the Ortho Guidance Precision Knee Software, is intended as a planning and intraoperative guidance system to enable open computer-assisted surgery. 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. #### 6.6.2 Ortho Guidance Express Knee Software The Stryker Ortho Q Guidance System, with the Ortho Guidance Express Knee Software, is intended as a planning and intraoperative guidance system to enable open computerassisted surgery. 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. {6}------------------------------------------------ ### 6.6.3 Ortho Guidance Versatile Hip Software The Stryker Ortho O Guidance System, with the Ortho Guidance Versatile Hip Software. is intended as a planning and intraoperative guidance system to enable open computerassisted surgery. The system 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 system is 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 ### 6.6.4 Stryker Ortho Q Guidance System The Stryker Ortho O Guidance System is intended as an aid for precisely locating anatomical structures in open computer assisted surgery. The 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 skull, vertebra, 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 Stryker OrthoMap Precision Knee 5.0 Software The technological comparison between the subject device (Ortho Guidance Precision Knee Software) and the predicate device (OrthoMap Precision Knee 5.0 Software) is included in Table 6-3 below. OrthoMap Precision Knee 5.0 Software received clearance per 510(k) number K162341. | Item | Subject Device: Ortho Guidance Precision Knee Software | Predicate Device: OrthoMap Precision Knee 5.0 Software (K162341) | |-----------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Platform Compatibility | • Stryker Ortho Q Guidance System | • Stryker NAV3i Platform Family including: • Stryker NAV3 Platform • Stryker NAV3i Platform • Stryker NavSuite3 kit Platform | | Compatible Operating System | • Linux (Yocto Distro Version 3.1.2, codename “dunfell”). | • Windows 8.1 | | Workflow Steps | • Patient Preparation • System Set-up • Patient Registration • Analyze Initial Alignment | • Patient Preparation • System Set-up • Patient Registration • Analyze Initial Alignment | | Stryker OrthoMap Precision Knee 5.0 Software | | |----------------------------------------------|--| {7}------------------------------------------------ | | Size and Position Implant | Size and Position Implant | |--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Resect Bones | Resect Bones | | | Analyze Trial Implant | Analyze Trial Implant | | | Analyze Final Implant | Analyze Final Implant | | Localization and Tracking Technology | Infrared Optical Active Tracking: Infrared light emitted by diodes placed in specific locations on tracked instruments is sensed by the navigation camera on the platform, which allows for computation of the position and orientation of the tracked instruments. | Infrared Optical Active Tracking: Infrared optical active sensing technology: Infrared light emitted by diodes placed in specific locations on navigated surgical instruments is sensed by a camera array (navigation camera) on the platform, which allows for computation of the spatial information | | Operating Principle | 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 | | Control Mechanism | 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 orange highlighted button indicates the selected function. | | Intended Use Environment | Operating Room (OR) | Operating Room (OR) | | Intended Users | Trained clinical staff | Trained clinical staff | | Graphical User Interface (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. | | User Interface | Surgeon's Monitor Small Touch Monitor Mouse Buttons on active optical instruments | Monitor I/O Tablet Mouse Buttons on active optical instruments | | Item | Subject Device: Ortho Guidance Express Knee Software | Predicate Device: OrthoMap Express Knee 2.0 Software (K153240) | | Platform Compatibility | Stryker Ortho Q Guidance System | Stryker NAV3i Platform Family including: Stryker NAV3 Platform Stryker NAV3i Platform Stryker NavSuite3 kit Platform | | Compatible Operating System | Linux (Yocto Distro Version 3.1.2, codename "dunfell"). | Windows 8.1 | | 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 (femur) Navigation (femur) Patient Registration (tibia) Navigation (tibia) | | Localization and Tracking Technology | Infrared Optical Active Tracking: Infrared light emitted by diodes placed in specific locations on tracked instruments is sensed by the navigation camera on the platform, which allows for computation of the position and orientation of the tracked instruments. | Infrared Optical Active Tracking: Infrared optical active sensing technology: Infrared light emitted by diodes placed in specific locations on navigated surgical instruments is sensed by a camera array (navigation camera) on the platform, which allows for computation of the spatial information | | Operating Principle | 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 | | Control Mechanism | 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 orange highlighted button indicates the selected function. | | Intended Use Environment | Operating Room (OR) | Operating Room (OR) | | Intended Users | Trained clinical staff | Trained clinical staff | | Graphical User Interface (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. | | | Mouse Buttons on active optical instruments | Mouse Buttons on active optical instruments | | Tracking Signal Output | Visual and auditory | Visual and auditory | #### 6.7.2 Technological Comparison between the Ortho Guidance Express Knee Software and Stryker OrthoMap Express Knee 2.0 Software The technological comparison between the subject device (Ortho Guidance Express Knee Software) and the predicate device (OrthoMap Express Knee 2.0 Software) is included in Table 6-4 below. OrthoMap Express Knee 2.0 Software received clearance per 510(k) number K153240. {8}------------------------------------------------ I/O Tablet . Small Touch Monitor ### Table 6-4: Technological Comparison between the Ortho Guidance Express Knee Software and Stryker OrthoMap Express Knee 2.0 Software {9}------------------------------------------------ #### 6.7.3 Technological Comparison between the Ortho Guidance Versatile Hip Software and Stryker OrthoMap Versatile Hip 2.0 Software The technological comparison between the subject device (Ortho Guidance Versatile Hip Software) and the predicate device (OrthoMap Versatile Hip 2.0 Software) is included in Table 6-5 below. OrthoMap Versatile Hip 2.0 Software received clearance per 510(k) number K162937. #### Table 6-5: Technological Comparison between the Ortho Guidance Versatile Hip Software and Stryker OrthoMap Versatile Hip 2.0 Software | Item | Subject Device: Ortho Guidance Versatile Hip Software | Predicate Device: OrthoMap Versatile Hip 2.0 Software (K162937) | |--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Platform Compatibility | Stryker Ortho Q Guidance System | Stryker NAV3i Platform Family including: Stryker NAV3 Platform Stryker NAV3i Platform Stryker NavSuite3 kit Platform | | Operating System | Linux (Yocto Distro Version 3.1.2, codename "dunfell"). | Windows 8.1 | | 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 | | Localization and Tracking Technology | Infrared Optical Active Tracking: Infrared light emitted by diodes placed in specific locations on tracked instruments is sensed by the navigation camera on the platform, which allows for computation of the position and orientation of the tracked instruments. | Infrared Optical Active Tracking: Infrared optical active sensing technology: Infrared light emitted by diodes placed in specific locations on navigated surgical instruments is sensed by a camera array (navigation camera) on the platform, which allows for computation of the spatial information | | Operating Principle | 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 | | Control Mechanism | 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. | 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. | {10}------------------------------------------------ | | The information of the software is displayed on a monitor. On the monitor, the blue highlighted button indicates the selected function. | The information of the software is displayed on a monitor. On the monitor, the orange highlighted button indicates the selected function. | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use Environment | Operating Room (OR) | Operating Room (OR) | | Intended Users | Trained clinical staff | Trained clinical staff. | | Graphical User Interface (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. | | User Interface | Surgeon's Monitor Small Touch Monitor Mouse Buttons on active optical instruments | Monitor I/O Tablet Mouse Buttons on active optical instruments | | Tracking Signal Output | Visual and auditory | Visual and auditory | #### 6.7.4 Technological Comparison between the Ortho Q Guidance System and Stryker Q Guidance System The technological comparison between the subject device (Ortho Q Guidance System) and the predicate device (Stryker Q Guidance System) is included in Table 6-6 below. Stryker Q Guidance System received clearance per 510(k) number K220593. | Table 6-6: Technological Comparison between the Ortho Q Guidance System and Stryker Q Guidance System | |-------------------------------------------------------------------------------------------------------| | | | Item | Subject Device: Ortho Q Guidance System | Predicate Device: Stryker Q Guidance System (K220593) | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Operating Principle | The Ortho Q Guidance System runs Stryker Ortho Guidance Software applications on a Linux based dual PC system. For patient data import/export, the system provides standard state-of-the-art storage media and network interfaces. For video import the system provides standard state-of-the-art video interface to capture live video. The Ortho Q Guidance System offers an active optical localization device (FP8000 Camera) that enables the calculation of relative spatial relationship of Stryker active optical instruments and trackers, which are equipped with LEDs by detecting the position of the light center of each single flashing LED. The Stryker Navigation Application Software is operated via active optical instruments during surgery. | The Q Guidance System runs Stryker Spine Guidance 4.0 Software on a Linux based dual PC system. For patient data import/export, the system provides standard state-of-the-art storage media and network interfaces. For video import the system provides standard state-of-the-art video interface to capture live video. The Q Guidance System offers an active and passive optical localization device (FP8000 Camera) that enables the calculation of relative spatial relationship of Stryker active optical instruments and trackers, which are equipped with LEDs, and passive optical instruments, which are equipped with reflective fiducials by detecting the position of the light center of each single flashing LED or the center of the reflective fiducials. The Spine Guidance 4.0 Software can be operated via active optical instruments during surgery. | | | | or via the touch monitors, mouse, and | | | | keyboard. | | Dimensions | Outer dimensions: Length x Width x Height: 770 x 700 x 1950 mm | Outer dimensions: Length x Width x Height: 950 x 720 x 1950 mm | | | Weight: 64 kg | Weight: 265 kg | | Environmental Conditions | Operation: Temperature: 10°C - 30°C Relative humidity: 30% – 75% Atmospheric pressure: 70 kPa – 106 kPa Transportation: Temperature: -10°C - 50°C Relative humidity: 10% - 90% Atmospheric pressure: 70 kPa – 106 kPa Storage: Temperature: 10°C - 50°C Relative humidity: 10% - 85% Atmospheric pressure: 70 kPa - 106 kPa | Operation: Temperature: 10°C - 30°C Relative humidity: 30% - 75% Atmospheric pressure: 70 kPa - 106 kPa Transportation: Temperature: -10°C - 50°C Relative humidity: 10% - 90% Atmospheric pressure: 70 kPa - 106 kPa Storage: Temperature: 10°C – 50°C Relative humidity: 10% - 85% Atmospheric pressure: 70 kPa - 106 kPa | | WiFi | TP-Link Archer T9UH, WiFi-USB - | TP-Link Archer T9UH, WiFi-USB - | | Connectivity | Adapter/Dongle | Adapter/Dongle | | Cable Guard Cart Castors | Spatula front mounted design | Spatula front mounted design | | Keyboard and Mouse | Man & Machine Petite Mouse Medical grade mini mouse; silicon 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 | | Application PC | Mainboard: MB-815-00A1E; Advantech Standard Server Board | 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 | 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: | Memory: | | | Liteon SSD, M.2 256 GB for Operating System and Applications Seagate Enterprise 2.5" HDD, 2TB storage, 7000rpm | Liteon SSD, M.2 256 GB for Operating System and Applications Seagate Enterprise 2.5" HDD, 2TB storage, 7000rpm | | | Graphics Card: NVIDIA RTX 2070 with 8 GByte video memory | Graphics Card: Leadtek Winfast RTX2070, 8GB RAM | | | Extension Cards: Magewell Pro Capture AIO 4k; digital 4k framegrabber Magewell Pro Capture AIO; mixed analog/digital | Extension Cards: Magewell Pro Capture AIO 4k; digital 4k framegrabber Magewell Pro Capture AIO; mixed analog/digital | | | | | | | DVP-7013E; analog framegrabber | DVP-7013E; analog framegrabber | | | 96NIC-1G4P-PE-IN2; Intel 4 Port Ethernet Card…