(132 days)
Not Found
No
The document describes a computer-assisted surgical guidance system using optical tracking and anatomical models, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
Explanation: The device is described as a planning and intraoperative guidance system that assists the surgeon in performing interventions, but it does not directly treat or cure a condition itself.
No
This device is described as a "planning and intraoperative guidance system" used to assist surgeons during computer-assisted surgery by localizing instruments and visualizing their position relative to anatomical landmarks. It does not state that it is used to diagnose a medical condition.
No
The device description explicitly states the system uses "active optical tracking technology" and mentions "localization of surgical instruments" and "visualization of their position relative to patient specific anatomical landmark information," which implies the use of hardware components beyond just software. The description also refers to the "Q Guidance System" as part of the overall system, which is likely a hardware component.
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 a "planning and intraoperative guidance system to enable open computer-assisted surgery." It is used to guide surgical instruments and visualize their position relative to anatomical structures during surgery.
- Device Description: The description reinforces this by explaining that it uses optical tracking technology to display the intraoperative location of surgical instruments.
- Lack of In Vitro Testing: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) outside of the body. The system interacts directly with the patient's anatomy during surgery.
- Performance Studies: The performance studies focus on accuracy in the surgical field, safety during use, software validation, and electrical/electromagnetic compatibility, all of which are relevant to a surgical guidance system, not an IVD.
IVD devices are used to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device's function is to assist in surgical procedures, not to perform diagnostic tests on patient samples.
N/A
Intended Use / Indications for 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.
Product codes
OLO
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.
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, tibia, long bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended User: Trained clinical staff
Care Setting: 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)
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: Intended Use/ User Needs
Summary of Testing: 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.
Item: Accuracy
Summary of Testing: The System is designed to work in the working space with a mean accuracy of 2 mm point and 2° angular axis displacement within the registration zone.
Item: Safety
Summary of Testing: Verified the effectiveness of all risk controls determined in the device risk analysis. No new questions of safety or effectiveness were raised.
Item: General Requirements and Performance
Summary of Testing: Verified all components against their design specifications. All requirements were met and no new questions of safety or effectiveness were raised.
Item: Software
Summary of Testing: 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.
Item: Biocompatibility
Summary of Testing: The subject devices are not intended to be patient contacting.
Item: Electrical Safety
Summary of Testing: Verified conformance to IEC 60601-1 Ed. 3.2 (2005 + AMD1:2012 + AMD2:2020).
Item: Electromagnetic Compatibility
Summary of Testing: Verified conformance to IEC 60601-1-2 Ed. 4.1 (2014 + AMD1:2020), CISPR 11 Group 1 Class A.
Item: Shipping
Summary of Testing: The functionality of the devices after simulated shipping conditions was verified. No new questions of safety or effectiveness were raised.
Item: Sterilization
Summary of Testing: The subject devices are not intended to be sterilized.
Summary of Clinical Testing:
No clinical testing was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
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"
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
Submission Number (if known)
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.
3
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4
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: | (401) 241-6152 |
| Email: | megan.guilbault@stryker.com |
| Date Prepared: | March 14, 2024 |
3.0 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 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 Device | |||
| Trade Name | 510(k) | Product | ||
| Code | Manufacturer | |||
| Ortho Guidance | ||||
| Precision Knee | ||||
| Software | Ortho Guidance | |||
| Precision Knee | ||||
| Software | K223767 | OLO | Stryker Leibinger | |
| GmbH & Co. KG | ||||
| Ortho Guidance | ||||
| Express Knee | ||||
| Software | Ortho Guidance | |||
| Express Knee Software | K223767 | OLO | Stryker Leibinger | |
| GmbH & Co. KG | ||||
| Ortho Guidance | ||||
| Versatile Hip | ||||
| Software | Ortho Guidance | |||
| Versatile Hip Software | K223767 | OLO | Stryker Leibinger | |
| GmbH & Co. KG | ||||
| Q Guidance System | Q Guidance System | K212194 | HAW | Stryker Leibinger |
| GmbH & Co. KG |
5
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.
6
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.
| | Predicate
Subject Device:
Ortho Guidance Precision Knee
Software | Predicate Device:
Ortho Guidance Precision Knee
Software (K223767) | Changes |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Item | | | |
| Platform
Compatibility | Stryker Ortho Q Guidance System
Stryker Q Guidance System | Stryker Ortho Q Guidance System | Added Stryker Q Guidance System |
| Compatible
Operating
System | Linux (Yocto Distro Version
3.1, 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 |
| 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 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. | No change |
Table 3: Technological Comparison between the Ortho Guidance Precision Knee Software and its Predicate
7
| 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 | No change |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| 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 blue highlighted
button indicates the selected
function. | No change |
| Intended Use
Environment | Operating Room (OR) | Operating Room (OR) | No change |
| Intended Users | Trained clinical staff | Trained clinical staff. | No change |
| 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. | 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 |
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.
8
| Item | Subject Device:
Ortho Guidance Express Knee Software | Predicate Device:
Ortho Guidance Express Knee
Software (K223767) | Changes |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Platform
Compatibility | Stryker Ortho Q Guidance System
Stryker Q Guidance System | Stryker Ortho Q Guidance System | Added Stryker Q Guidance System |
| Compatible
Operating
System | Linux (Yocto Distro Version
3.1, 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 |
| 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 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. | No change |
| 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 | No change |
| 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 blue highlighted
button indicates the selected
function. | No change |
| Intended Use
Environment | Operating Room (OR) | Operating Room (OR) | No change |
| Intended Users | Trained clinical staff | Trained clinical staff | No change |
| 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. | 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 |
9
| Buttons on active optical instruments | |||
|---|---|---|---|
| Tracking Signal | |||
| Output | 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 Hip
Software (K223767) | Changes |
|--|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| | Platform
Compatibility | Stryker Ortho Q Guidance System
Stryker Q Guidance System | Stryker Ortho Q Guidance System | Added Stryker Q Guidance System |
| | Operating
System | Linux (Yocto Distro Version
3.1, 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 |
| | 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 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. | No change |
| | 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 | No change |
| | 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 blue highlighted button indicates the selected function | No change |
10
| Intended Use
| Environment | Operating Room (OR) | Operating Room (OR) | No change |
|---|---|---|---|
| Intended Users | Trained clinical staff | Trained clinical staff. | No change |
| 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. | 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 Signal | |||
| Output | 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) | ||
| Operating | |||
| Principle | The software is installed on the | ||
| • computer that is part of the | |||
| platform | |||
| Images are imported in | |||
| • DICOM format | |||
| The software displays images | |||
| • and planned items with | |||
| navigational information on a | |||
| monitor | The software is installed on the | ||
| • computer that is part of the | |||
| platform | |||
| Images are imported in DICOM | |||
| • format | |||
| The software displays images | |||
| • and planned items with | |||
| navigational information on a | |||
| monitor | Identical - the Ortho Guidance Software | ||
| applications are imageless and do use the | |||
| image import functionality that is | |||
| available 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 | ||
| 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% | 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% | No change | ||
| Atmospheric pressure: 70 kPa – 106 kPa | Atmospheric pressure: 70 kPa – 106 kPa | No change | |
| WiFi Connectivity | |||
| TP-Link Archer T9UH, WiFi-USB - Adapter/Dongle | TP-Link Archer T9UH, WiFi-USB - Adapter/Dongle | No change | |
| Cable Guard | |||
| Spatula front mounted design | Spatula front mounted design | No change | |
| Cart Castors | |||
| Keyboard 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 change |
| No change | |||
| Similar | |||
| No change | |||
| RFID Reader | |||
| Optical Drive | Omnikey 5127CK-Mini, 13.56 MHz | ||
| Lite-On Slim 8X SATA DVD+/-RW Dual Layer | Omnikey 5127CK-Mini, 13.56 MHz | ||
| Lite-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 2400MHz | |||
| Extension Cards | 16 GB DDR4 2400MHz | ||
| Extension 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 |
| Operating | |||
| System | Linux (Yocto Distro Version | ||
| 3.1, codename "dunfell"). | Linux (Yocto Distro Version | ||
| 3.1, codename "dunfell"). | No change | ||
| Surgeon's | |||
| Monitor | Connect via HDMI interface | ||
| Multi Touch functionality | |||
| AG80 anti-glare coating | |||
| 32" | Connect via HDMI interface | ||
| Multi Touch functionality | |||
| AG80 anti-glare coating | |||
| 32" | No change | ||
| Small Touch | |||
| Monitor | Connected via Display Port | ||
| interface (DP) | |||
| 15.6" Touch display | |||
| AG80 anti-glare coating | |||
| No DVD-RW drive | |||
| No integrated RFID reader | |||
| No integrated power On/Off | |||
| button | |||
| No integrated LED indicators | |||
| No integrated virtual keyboard | Connected via Display Port | ||
| interface (DP) | |||
| 15.6" Touch display | |||
| AG80 anti-glare coating | |||
| No DVD-RW drive | |||
| No integrated RFID reader | |||
| No integrated power On/Off | |||
| button | |||
| No integrated LED indicators | |||
| No integrated virtual keyboard | No change | ||
| PowerBox | XP-Power Custom Design | ||
| AC/DC power supplies (5V, | |||
| 24V, 48V) | |||
| Battery with 9000mAh | |||
| System can operate without | |||
| battery | XP-Power Custom Design | ||
| AC/DC power supplies (5V, | |||
| 24V, 48V) | |||
| Battery with 9000mAh | |||
| System can operate without | |||
| battery | No change | ||
| Connector | |||
| Panel | USB3.0 port for data import | ||
| (2) Low Latency Ethernet ports | |||
| (3) Standard Ethernet ports | |||
| Analog S-Video input | |||
| Analog NTSC/PAL Video | |||
| input | |||
| Digital DVI-D input | |||
| 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 | USB3.0 port for data import | ||
| (2) Low Latency Ethernet ports | |||
| (3) Standard Ethernet ports | |||
| Analog S-Video input | |||
| Analog NTSC/PAL Video input | |||
| Digital DVI-D input | |||
| 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 | No change | ||
| 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. | No change | ||
| Fiducial Types | Single flashing LEDs | ||
| Parallel flashing LEDs | |||
| Continuous illuminated LEDs | |||
| Reflecting infrared markers | |||
| which reflect infrared light | |||
| originating from the FP8000 | Single flashing LEDs | ||
| Parallel flashing LEDs | |||
| Continuous illuminated LEDs | |||
| Reflecting infrared markers | |||
| which reflect infrared light | |||
| originating from the FP8000 | No change | ||
| All fiducial types can be tracked in | |||
| parallel, except for single flashing LEDs. | All fiducial types can be tracked in | ||
| parallel, except for single flashing LEDs. | No change | ||
| 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 | No change |
| Data | |||
| Communication | Ethernet Link | Ethernet Link | No change |
| 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. | No change |
| Sensor Frame
Rate | 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