(60 days)
Not Found
No
The document describes a computer-assisted surgical guidance system using optical tracking and anatomical models. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for such algorithms. The focus is on precise localization and visualization based on established computer-assisted surgery principles.
No.
This system is a surgical navigation and guidance tool, aiding in planning and precisely locating anatomical structures during surgery, rather than directly treating or curing a medical condition.
No
Explanation: The device is described as a "planning and intraoperative guidance system to enable open computer-assisted surgery," specifically for "precisely locating anatomical structures" and assisting surgeons with "high level of precision" during interventions. It is not intended for diagnosing medical conditions.
No
The submission describes both software applications (Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software) and a "new guidance system" (Ortho Q Guidance System). The device description explicitly states the purpose is to seek clearance for "3 new software applications and 1 new guidance system." Furthermore, the system utilizes "active optical tracking technology," which implies hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "planning and intraoperative guidance system to enable open computer-assisted surgery." It is used to assist surgeons during surgical procedures by providing guidance and localization of instruments relative to anatomical structures.
- Device Description: The description reinforces this by explaining that the system uses optical tracking technology to display the position of surgical instruments relative to a computed anatomical model.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens. Its function is to guide surgical procedures based on anatomical landmarks and instrument positions.
Therefore, the Stryker Ortho Q Guidance System and its associated software applications are surgical guidance systems, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for 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:
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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee joint, Hip joint, pelvis, femur, skull, vertebra, long bone.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained clinical staff, Operating Room (OR)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Ortho 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.
Intended Use/ User Needs: The subject devices were validated with intended users in cadaver labs or simulated use tests to ensure the user needs and intended use requirements were met. All requirements were met and no new issues of safety or effectiveness were raised.
Accuracy: The System is designed to work in the working space with a mean accuracy of 2 mm point and 2 degrees angular axis displacement within the registration zone. The 95th percentile of the point displacement is
§ 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).
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)
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3
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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 | 96NIC-1G4P-PE-IN2; Intel 4 Port Ethernet Card |
| | 968AD00483; USB to RS422 converter module | 968AD00483; USB to RS422 converter module |
| RFID Reader | Omnikey 5127CK-Mini, 13.56 MHz | Omnikey 5127CK-Mini, 13.56 MHz |
| Optical Drive | Lite-On Slim 8X SATA DVD+/-RW Dual Layer | Lite-On Slim 8X SATA DVD+/-RW Dual
Layer |
| RealTime PC | Mainboard | Mainboard |
| | AIMB-275G2-00A1E; Advantech Standard Mini ITX Board | AIMB-275G2-00A1E; Advantech Standard Mini ITX Board |
| | CPU | CPU |
| | Intel Core i7-7700T | Intel Core i7-7700T |
| | 4 Cores, 8 Threads | 4 Cores, 8 Threads |
| | Base clock 2.9 GHz / Boost clock 3.8 GHz | Base clock 2.9 GHz / Boost clock 3.8 GHz |
| | 8 MB Smart Cache | 8 MB Smart Cache |
| | RAM | RAM |
| | 16 GB DDR4 2400MHz | 16 GB DDR4 2400MHz |
| | Extension Cards | Extension Cards |
| | Advantech DMS-IR06 dual port LAN card | Advantech DMS-IR06 dual port LAN card |
| Power Supply | 100-240 VAC, 50-60 Hz, 6.9-2.9 A | Zippy DHG2-5600V, 600W, 48V-DC |
| Operating
System | Linux (Yocto Distro Version 3.1.2, codename "dunfell"). | Linux (Yocto Distro Version 3.1.2, codename "dunfell"). |
| Surgeon's
Monitor | Connect via HDMI interface | Connect via HDMI interface |
| | Multi Touch functionality | Multi Touch functionality |
| | AG80 anti-glare coating | AG80 anti-glare coating |
| | 27" | 32" |
| Small Touch
Monitor | Connected via Display Port interface (DP) | Connected via Display Port interface (DP) |
| | 15.6" Touch display | 15.6" Touch display |
| | AG80 anti-glare coating | AG80 anti-glare coating |
| | No DVD-RW drive | No DVD-RW drive |
| | No integrated RFID reader | No integrated RFID reader |
| | No integrated power On/Off button | No integrated power On/Off button |
| | No integrated LED indicators | No integrated LED indicators |
| | No integrated virtual keyboard | No integrated virtual keyboard |
| PowerBox | XP-Power Custom Design | XP-Power Custom Design |
| | AC/DC power supplies (5V, 24V, 48V) | AC/DC power supplies (5V, 24V, 48V) |
| | Battery with 9000mAh | Battery with 9000mAh |
| | System can operate without battery | System can operate without battery |
| Connector
Panel | USB3.0 port for data import | USB3.0 port for data import |
| | (2) Low Latency Ethernet ports | (2) Low Latency Ethernet ports |
| | Analog S-Video input | (3) Standard Ethernet ports |
| | Digital DVI-D input | Analog S-Video input |
| | Digital 4K SDI Video input | Analog NTSC/PAL Video input |
| | Digital 4K HDMI Video input | Digital DVI-D input |
| | HDMI output for connecting external monitors | Digital 4K SDI Video input |
| | | Digital 4K HDMI Video input |
| | | |
| | | |
| | | EM Instrument Adapter Box
port (data signals / power) HDMI output for connecting
external monitors Display Port Video output |
| Operating
Principle | The FP8000 Camera enables the
calculation of relative spatial relationship
of Stryker Navigated Instruments and
Trackers which are equipped with IR
fiducials by detecting the position of the
light center of each fiducial. | The FP8000 Camera enables the
calculation of relative spatial relationship
of Stryker Navigated Instruments and
Trackers which are equipped with IR
fiducials by detecting the position of the
light center of each fiducial. |
| Fiducial Types | Single flashing LEDs Parallel flashing LEDs Continuous illuminated LEDs Reflecting infrared markers
which reflect infrared light
originating from the FP8000
Camera. All fiducial types can be tracked in
parallel, except for single flashing LEDs. | Single flashing LEDs Parallel flashing LEDs Continuous illuminated LEDs Reflecting infrared markers
which reflect infrared light
originating from the FP8000
Camera. All fiducial types can be tracked in
parallel, except for single flashing LEDs. |
| Infrared
Sensors | Two 2D sensor arrays arranged at certain
fixed distances to each other. Each of
the two sensor arrays receives a signal
from all illuminated fiducials. This
allows for the calculation of the three-
dimensional position of the fiducial from
the two-dimensional sensors, commonly
known for stereo camera systems | Two 2D sensor arrays arranged at certain
fixed distances to each other. Each of the
two sensor arrays receives a signal from
all illuminated fiducials. This allows for
the calculation of the three-dimensional
position of the fiducial from the two-
dimensional sensors, commonly known
for stereo camera systems |
| Instrument
Communication | Bi-direction IR communication | Bi-direction IR communication |
| Data
Communication | Ethernet Link | Ethernet Link |
| Pose
Calculation | Two dimensional light centroids are
calculated based on each of the two
sensor images.
By triangulating the centroids, the 3D
position of the illuminated fiducials can
be calculated. Multiple centroids can be
acquired at once by illuminating the
fiducials in parallel.
By matching the 3D positions of the
single fiducials to a known instrument
geometry the correspondence between
measured fiducial positions and fiducials
on the instrument can be solved as well
as position and orientation of the
navigated instruments is calculated. | Two dimensional light centroids are
calculated based on each of the two sensor
images.
By triangulating the centroids, the 3D
position of the illuminated fiducials can be
calculated. Multiple centroids can be
acquired at once by illuminating the
fiducials in parallel.
By matching the 3D positions of the single
fiducials to a known instrument geometry
the correspondence between measured
fiducial positions and fiducials on the
instrument can be solved as well as
position and orientation of the navigated
instruments is calculated. |
| Sensor Frame
Rate | Up to 500 Hz, applicable to all fiducials | Up to 500 Hz, applicable to all fiducials |
| Accuracy | Trueness for LED fiducial:
mean Euclidean error