(90 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms in the device description, intended use, or performance studies. The functionality described is image-guided navigation based on optical tracking and pre-operative planning, which are standard features of such systems and do not inherently require AI/ML.
No.
The device is an image-guided system used for planning and intraoperative guidance during spinal surgery to assist in the precise positioning of instruments, not to directly treat a medical condition.
No
The device is an intraoperative guidance system used during surgery to assist in positioning instruments and locating patient anatomy, not to diagnose a medical condition.
No
The device description explicitly states that the system is comprised of software and various hardware components, including a computer platform, navigated accessories/instruments, calibration devices, navigation adaptors, patient/instrument trackers, a camera, and monitors.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Q Guidance System is a surgical planning and guidance system. It uses imaging data (CT, MR, PET, DICOM) to help surgeons navigate and position instruments during spinal and pelvic surgery. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's for "planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery." This is a surgical tool, not a diagnostic test performed on a sample.
The device's purpose is to assist in surgical procedures, not to diagnose a condition based on laboratory analysis of patient specimens.
N/A
Intended Use / Indications for Use
Spine Guidance Software 5.0
The Q Guidance System, when used with the Spine Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients. The system is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified. The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
Screw and Needle placement in the spine or pelvis.
Q Pedicle Instruments (QPI)
Stryker Spine Q Pedicle Instruments are intended to be used as accessories to the Stryker Spine Guidance System to facilitate placement of Stryker Spine implants. They can be navigated instruments or non-navigated manual instruments. When navigated, Stryker Spine Q Pedicle Instruments are specifically designed for use with the Spine Guidance Software. They are intended to be used with a Q Navigation Adaptor and associated trackers manually or under power with a Stryker Rotary Handpiece to facilitate pedicle preparation and placement of Stryker Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients in accordance with the indications and contraindications of the associated Stryker Spine Implant System.
Consolidated Operating Room Equipment (CORE) 2 Console
The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to orthopedic, dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients.
Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece
The Stryker Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece is used with the Consolidated Operating Room Equipment (CORE™) System. When used with a variety of Strykerapproved attachments, the handpiece is intended for orthopedic surgical procedures involving drilling. reaming, driving wire or pins, cutting bone and hard tissue. The Stryker Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece, when used in conjunction with Stryker Spine Guidance Software, is intended to be used to facilitate preparation and placement of screws of Stryker Spine implant systems in adult and pediatric (adolescent) patients.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The Spine Guidance 5.0 system is an image guided stereotaxic, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery.
The system is comprised of the Spine Guidance 5.0 Software, the Q Guidance System (computer platform), navigated accessories/ instruments (e.g., powered drills, pointers), and various system components (e.g., calibration devices, navigation adaptors, patient/ instrument trackers, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, big touchscreen monitor, and a small touchscreen monitor. The Spine Guidance 5.0 software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices,
The following new instrumentation can be used with the system:
- . The Q Pedicle Instruments are intended to be used to facilitate pedicle preparation and screw placement of Stryker Spine implant systems.
- . The CORE 2 Console has three handpiece ports. two footswitch ports, and one irrigation cassette port. The console supplies power to devices for a variety of surgical procedures as described in its indications for use. It is comprised of a power supply, central processing unit, motor controller, irrigation pump controller, RFID module, liquid crystal display (LCD) screen and speaker for output, touch screen for user input, USB port, and an Ethernet port. The CORE 2 software contains an optional depth-stop feature driven by Spine Guidance 5 Software.
- . The ES 6 Heavy Duty Dual Trigger Rotary Handpiece is used in drilling, reaming and decorticating of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement of screws, wires, pins, and other fixation devices. This handpiece supports the depth-stop feature.
This system is for professional use only within a professional healthcare environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed tomography (CT)
Magnetic resonance (MR)
Position emission tomography (PET)
2D DICOM images (SCOUT only)
Anatomical Site
Spine, Pelvis, Skull (for reference)
Indicated Patient Age Range
adult and pediatric (adolescent) patients
Intended User / Care Setting
professional use only within a professional healthcare environment.
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 have been evaluated through non-clinical design verification and validation testing. Additional testing was performed on the subject devices to ensure they met their design requirements. The results of the evaluation tests demonstrate that the subject devices successfully meet the requirements of their intended use.
Accuracy
System demonstrated performance in 3D positional accuracy with a mean error
§ 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
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Build Correspondence
June 6, 2024
Stryker Leibinger GmbH & Co. KG Andrea Wallen-Gerding Principal Regulatory Affairs Specialist Bötzinger Straße 41 Freiburg Baden-Wurttembe, D-79111 Germany
Re: K240662
Trade/Device Name: Spine Guidance Software (version 5.0); Xia 3/ Serrato O Instruments: Everest Q Instruments; Mesa 2 Q Instruments; 0 Pedicle Preparation Instruments; 0 S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece
Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 8, 2024 Received: March 8, 2024
Dear Andrea Wallen-Gerding:
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/cdrb/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.
1
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" (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 820.70) 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 mediation-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 Alı, M Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
- · Spine Guidance Software (version 5.0)
- · Q Pedicle Instruments
- o Xia 3 Q Taps
- o Serrato Q Taps
- o Xia 3/Serrato Q Screwdriver
- o ES2 Q Taps
- o ES2 Q Screwdriver
- o Everest Q Taps
- o Everest MI XT Q Taps
- o Everest Q Screwdriver
- o Everest MI XT Q Screwdriver
- o Mesa 2 Q Taps
- o Mesa 2 Q Screwdriver
- o Q S2Al Drills
- o Q Drills
- o Q Awl
- o Q Thoracic Probe
- o Q Lumbar Probe
- o Q Ratchet T-Handle
- o Q Ratchet Round Handle
- o Q Gear Shift Handle
- · Consolidated Operating Room Equipment (CORE) 2 Console
- · Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece
Indications for Use (Describe)
Spine Guidance Software 5.0
The Q Guidance System, when used with the Spine Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients. The system is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified. The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
· Screw and Needle placement in the spine or pelvis.
Q Pedicle Instruments (QPI)
Stryker Spine Q Pedicle Instruments are intended to be used as accessories to the Stryker Spine Guidance System to facilitate placement of Stryker Spine implants. They can be navigated instruments or non-navigated manual instruments. When navigated, Stryker Spine Q Pedicle Instruments are specifically designed for use with the Spine Guidance Software. They are intended to be used with a Q Navigation Adaptor and associated trackers manually or under power with a Stryker Rotary Handpiece to facilitate pedicle preparation and placement of Stryker Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients in accordance with the
4
indications and contraindications of the associated Stryker Spine Implant System.
Consolidated Operating Room Equipment (CORE) 2 Console
The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to orthopedic, dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices. The CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients.
Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece
The Stryker Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece is used with the Consolidated Operating Room Equipment (CORE™) System. When used with a variety of Strykerapproved attachments, the handpiece is intended for orthopedic surgical procedures involving drilling, reaming, driving wire or pins, cutting bone and hard tissue. The Stryker Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece, when used in conjunction with Stryker Spine Guidance Software, is intended to be used to facilitate preparation and placement of screws of Stryker Spine implant systems in adult and pediatric (adolescent) patients.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
he-Counter Use (21 CFR 801 Subpart C)
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5
ar
| 807.92(a)(1) - Submitter Information | |
|---|---|
| 510(k) Submitter: | Stryker Leibinger GmbH & Co. KG |
| Bötzinger Straße 41 | |
| 79111 Freiburg, Germany | |
| Contact Information: | Primary: |
| Andrea N. Wallen-Gerding | |
| Principal Regulatory Affairs Specialist | |
| (269) 491-9234 | |
| andrea.wallengerding@stryker.com |
Secondary:
Kirsten Reinhold
Senior Manager, Regulatory Affairs
(201) 419-9044
kirsten.reinhold@stryker.com |
| Date Summary Prepared: | March 7, 2024 |
510(k) Summary - K240662
| 807.92(a)(2) – Name of Device | |
|---|---|
| Trade Name(s): | • Spine Guidance Software (version 5.0) • Q Pedicle Instruments ○ Xia 3 Q Taps ○ Serrato Q Taps ○ Xia 3/Serrato Q Screwdriver ○ ES2 Q Taps ○ ES2 Q Screwdriver ○ Everest Q Taps ○ Everest MI XT Q Taps ○ Everest Q Screwdriver ○ Everest MI XT Q Screwdriver ○ Mesa 2 Q Taps ○ Mesa 2 Q Screwdriver ○ Q S2AI Drills ○ Q Drills ○ Q Awl ○ Q Thoracic Probe ○ Q Lumbar Probe ○ Q Ratchet T-Handle ○ Q Ratchet Round Handle ○ Q Gear Shift Handle • Consolidated Operating Room Equipment (CORE) 2 Console • Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece |
| Classification Name: | Orthopedic Stereotaxic Instrument |
| Device Class: | Class II (21 CFR 882.4560) |
| Product Code(s): | OLO |
Stryker Leibinger GmbH & Co. KG
6
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
|---|---|
| Spine Guidance Software, v5.0 | Spine Guidance Software, v4.0, K220593 |
| Q Pedicle Instruments | Navigated Spine Instruments, K203205, K172034 |
| Consolidated Operating Room Equipment | |
| (CORE) 2 Console | Stryker Consolidated Operating Room Equipment |
| (CORE) 2 Console, K171840 | |
| Electric System 6 Heavy Duty Dual Trigger | |
| Rotary Handpiece | FDA Product Code: HWE (Instrument, Surgical, |
| Orthopedic, AC-Powered Motor and Accessory/ | |
| Attachment) | |
| Regulation Number: 878.4820 |
007 02/~/2)
807.92(a)(4) - Device Description
Spine Guidance 5.0 System Overview
The Spine Guidance 5.0 system is an image guided stereotaxic, planning, and intraoperative guidance system intended to enable open or percutaneous computer-assisted surgery. It assists the surgeon in precisely positioning manual and powered instruments and locating patient anatomy during spinal surgery.
The system is comprised of the Spine Guidance 5.0 Software, the O Guidance System (computer platform), navigated accessories/ instruments (e.g., powered drills, pointers), and various system components (e.g., calibration devices, navigation adaptors, patient/ instrument trackers, etc.). The system provides intraoperative guidance to the surgeon using passive and active wireless optical tracking technologies. The computer platform consists of a computer, camera, big touchscreen monitor, and a small touchscreen monitor. The Spine Guidance 5.0 software functionality is described in terms of its capabilities that feature planning, registration, and navigation of medical devices,
The following new instrumentation can be used with the system:
- . The O Pedicle Instruments are intended to be used to facilitate pedicle preparation and screw placement of Stryker Spine implant systems.
- . The CORE 2 Console has three handpiece ports. two footswitch ports, and one irrigation cassette port. The console supplies power to devices for a variety of surgical procedures as described in its indications for use. It is comprised of a power supply, central processing unit, motor controller, irrigation pump controller, RFID module, liquid crystal display (LCD) screen and speaker for output, touch screen for user input, USB port, and an Ethernet port. The CORE 2 software contains an optional depth-stop feature driven by Spine Guidance 5 Software.
- . The ES 6 Heavy Duty Dual Trigger Rotary Handpiece is used in drilling, reaming and decorticating of bone and other bone related tissue in a variety of surgical procedures. It is also usable in the placement of screws, wires, pins, and other fixation devices. This handpiece supports the depth-stop feature.
This system is for professional use only within a professional healthcare environment.
Stryker Leibinger GmbH & Co. KG
7
807.92(a)(5) - Intended Use of the Device Indications for Use:
Spine Guidance Software 5.0
The Q Guidance System, when used with the Spine Guidance Software, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery in adult and pediatric (adolescent) patients.
The system is indicated for any surgical procedure on the spine in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure such as the skull, pelvis or spine can be identified.
The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
- Screw and Needle placement in the spine or pelvis.
Q Pedicle Instruments (QPI)
Stryker Spine Q Pedicle Instruments are intended to be used as accessories to the Stryker Spine Guidance System to facilitate placement of Stryker Spine implants. They can be navigated instruments or nonnavigated manual instruments. When navigated, Stryker Spine Q Pedicle Instruments are specifically designed for use with the Spine Guidance Software. They are intended to be used with a Q Navigation Adaptor and associated trackers manually or under power with a Stryker Rotary Handpiece to facilitate pedicle preparation and placement of Stryker Spine implants in the non-cervical spine in adult and pediatric (adolescent) patients in accordance with the indications and contraindications of the associated Stryker Spine Implant System.
Consolidated Operating Room Equipment (CORE) 2 Console
The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to orthopedic, dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients.
Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece
The Stryker Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece is used with the Consolidated Operating Room Equipment (CORE™) System. When used with a variety of Strykerapproved attachments, the handpiece is intended for orthopedic surgical procedures involving drilling. reaming, driving wire or pins, cutting bone and hard tissue.
The Stryker Electric System 6 Heavy Duty Dual Trigger Rotary Handpiece, when used in conjunction with Stryker Spine Guidance Software, is intended to be used to facilitate preparation and placement of screws of Stryker Spine implant systems in adult and pediatric (adolescent) patients.
Stryker Leibinger GmbH & Co. KG
8
| Characteristic | Subject Device | Predicate Device |
|---|---|---|
| Indication(s) | The Q Guidance System, when used | |
| with the Spine Guidance Software, is | ||
| intended as a planning and | ||
| intraoperative guidance system to | ||
| enable open or percutaneous | ||
| computer assisted surgery in adult | ||
| and pediatric (adolescent) patients. |
The system is indicated for any
surgical procedure on the spine in
which the use of computer assisted
planning and surgery may be
appropriate. The system can be used
for intraoperative guidance where a
reference to a rigid anatomical
structure such as the skull, pelvis or
spine can be identified.
The system assists in the positioning
of instruments for procedures on the
pelvis and spine, including:
• Screw and needle placement in
the spine or pelvis | The Stryker Q Guidance System,
when used with the Spine
Guidance Software, is intended a
a planning and intraoperative
guidance system to enable open
or percutaneous computer
assisted surgery in adult and
pediatric patients.
The system is indicated for any
surgical procedure on the spine in
which the use of computer
assisted planning and surgery
may be appropriate. The system
can be used for intraoperative
guidance where a reference to a
rigid anatomical structure such as
the spine, pelvis or skull can be
identified.
The system assists in the
positioning of instruments for
procedures on the spine and
pelvis, including:
• Screw Placement in the spine
or pelvis |
| Main System Components | • Q Guidance System
• Navigated Instruments
• System accessories and
components | • Q Guidance System
• Navigated Instruments
• System accessories and
components |
| Modes of Operation | • Patient Preparation
• System Set-up
• Image Import
• Planning
• Patient Registration
• Navigation | • Patient Preparation
• System Set-up
• Image Import
• Planning
• Patient Registration
• Navigation |
| Localizing and Tracking | Infrared Optical Active and Passive
Tracking | Infrared Optical Active and
Passive Tracking |
| System Accuracy | The system has a mean accuracy of 2
mm for positional displacement and
2° for trajectory angle displacement.
Accuracy values apply to tracking in
the workspace. | The system has a mean accuracy
of 2 mm for positional
displacement and 2° for trajectory
angle displacement. Accuracy
values apply to tracking in the
workspace. |
| Supported Imaging
Modalities | Computed tomography (CT) Magnetic resonance (MR) Position emission tomography (PET) 2D DICOM images (SCOUT only) | Computed tomography (CT) Magnetic resonance (MR) Position emission tomography (PET) |
| Planning Features | Screws Measurements Trajectories Segmentations (Manual and automatic) Merge Levels (local correlation) | Screws Measurements Trajectories Segmentations (Manual and automatic) Merge Levels (local correlation) Image merge |
| Registration Features | Anatomical (Point-to-Point) Registration Surface Registration 3D CT/ C-Arm Registration Automatic Intraoperative Mask Registration | Anatomical (Point-to-Point) Registration Surface Registration 3D CT/ C-Arm Registration Automatic Intraoperative Mask Registration Mask Registration |
| Intended Use Environment | Operating Room (OR) | Operating Room (OR) |
| Output | 3D image Analog and Digital Video Images | 3D image Analog and Digital Video Images |
| Graphical User
Interface | Black-style graphical user interface 16:9 screen ratio Case Dashboard to access all operation modes One tab per task concept from left to right on top of screen Image box with image tools Current task panel on the right or bottom Image settings task panel on the left | Black-style graphical user interface 16:9 screen ratio Case Dashboard to access all operation modes Image box with image tools Current task panel on the right Image settings task panel on the left |
| User Interface | Large touch monitor Small touch monitor Keyboard Mouse Buttons on active optical instruments | Large touch monitor Small touch monitor Keyboard Mouse Buttons on active optical instruments |
Stryker Leibinger GmbH & Co. KG
9
Technological Comparison between the Navigated Q Pedicle Instruments and their predicate devices
The navigated Q Pedicle Instruments in scope of this traditional 510(k) have similar designs, materials, intended use, sterilization, and fundamental scientific technology to their predicate devices and system
Stryker Leibinger GmbH & Co. KG
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Image /page/10/Picture/0 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase and appears to be a logo or brand name. The letters are closely spaced, giving the word a compact appearance. The color of the text is black, and it is set against a white background.
components. The modifications to the instruments do not adversely impact the technological characteristics of the predicate devices.
Technological Comparison between the CORE 2 Console and its predicate device
There have been no changes made to the intended use, materials, or fundamental scientific technology of the CORE 2 Console. The device has undergone a software modification to enable communication with the Spine Guidance 5.0 Software System. The indications for use have also been updated to allow use with the Spine Guidance 5 Software.
Technological Comparison between the Electric System 6 and its predicate device
There have been no changes to the intended use, design, materials, fundamental scientific technology, or sterilization process. The only update is to the indication for use to allow it to be used with the Spine Guidance 5 Software.
807.92(b)(1) – Nonclinical Testing to Support Submission
The function and performance of the subject devices have been evaluated through non-clinical design verification and validation testing. Additional testing was performed on the subject devices to ensure they met their design requirements. The results of the evaluation tests demonstrate that the subject devices successfully meet the requirements of their intended use.
Accuracy
System demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0mm and in trajectory angle accuracy with a mean error