(234 days)
Yes
The "Device Description" section explicitly states that an "Artificial Intelligence (AI) spine segmentation algorithm, based on Convolutional Neural Network (CNN), has been added to provide an improved virtual 3D spine model." The "Summary of Performance Studies" also mentions the validation of this AI segmentation algorithm.
No.
The device is an image-guided navigation system intended as an aid for precisely locating anatomical structures during spinal procedures, not for treating any medical condition directly.
No
The device is an image-guided navigation system intended as an aid for precisely locating anatomical structures during spine procedures, assisting surgeons in placing screws accurately. It does not diagnose medical conditions or diseases.
No
The device description explicitly states that the system consists of dedicated software, a Headset, single-use passive reflective markers, and reusable components, indicating it includes hardware.
Based on the provided information, the xvision Spine System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- xvision Spine System Function: The xvision Spine System is an image-guided navigation system used during surgical procedures. It uses imaging data (CT scans) and tracking technology to help surgeons visualize and accurately place instruments and implants within the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it is an "aid for precisely locating anatomical structures in either open or percutaneous spine procedures." This is a surgical aid, not a diagnostic test performed on a sample.
Therefore, the xvision Spine System falls under the category of a surgical navigation system or image-guided surgery system, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states 'Not Found'.
Intended Use / Indications for Use
The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT imagery of the anatomy. This can include the following spinal implant procedures:
- Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
- Posterior Screw Placement in C3-C7 vertebrae
- Iliosacral Screw Placement
The Headset of the xvision System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and trajectory planning.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
Product codes
OLO
Device Description
The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Headset, single use passive reflective markers and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.
The following modifications have been applied to the previously cleared XVS system:
The indications for use of the subject device are expanded compared to the cleared predicate device and include screw instrumentation in additional spine segments, i.e., cervical C3-C7 vertebrae and iliosacral region. Additionally, an Artificial Intelligence (AI) spine segmentation algorithm, based on Convolutional Neural Network (CNN), has been added to provide an improved virtual 3D spine model. The virtual 3D model can be built from the original CT scan or from the Al segmented CT scan. Neither of these modifications alters the intended use of the device as an aid in localization during spine surgery or its principles of operation.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
X-Ray Based Imaging
Anatomical Site
spine or pelvis, thoracic and sacro-lumbar region, C3-C7 vertebrae, Iliosacral region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgeons or neurosurgeons, Operating Room
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
The performance of the AI segmentation algorithm was validated on a set of intra-op CT scans by comparing it with manual segmentations that were approved by US physicians.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Study Type: Cadaver studies
- Sample Size: Not specified
- Accuracy: The system's accuracy was validated in two cadaver studies, in which screws were positioned in C3-C7 cervical vertebrae and in the sacro-iliac segment. The positional and trajectory errors were calculated as the difference between the actual and virtual screw tip position, and the difference between the screw orientation and its recorded virtual trajectory. Additionally, clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing the post-op scans.
- AI Segmentation Validation: The performance of the AI segmentation algorithm was validated on a set of intra-op CT scans by comparing it with manual segmentations that were approved by US physicians.
- Key Results: The mean Dice coefficient was calculated as the measured quality of the algorithm. All performance testing demonstrates that the xvision System performs according to specifications and functions as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
mean Dice coefficient
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 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 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.
November 17, 2022
Augmedics Ltd. % Janice Hogan Partner Hogan Lovells, US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K220905
Trade/Device Name: xvision Spine System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 20, 2022 Received: October 20, 2022
Dear Janice Hogan:
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.
1
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 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 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.
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) K220905
Device Name xvision Spine System
Indications for Use (Describe)
The xvision Spine System, with xvision System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT imagery of the anatomy. This can include the following spinal implant procedures:
- Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
- Posterior Screw Placement in C3-C7 vertebrae
- Iliosacral Screw Placement
The Headset of the xvision System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and trajectory planning.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
| 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
510(k) SUMMARY
Augmedics xvision Spine System
Submitter
Augmedics Ltd. 1 Ha-Tsmikha St. Yokneam Illit. 2069205 Israel
Phone: +972-4-3730111 Facsimile: +972-4-3730850
Contact Person: Tami Harel Date Prepared: November 17, 2022
Name of Device: xvision Spine System
Common or Usual Name: XVS
Classification Name: Orthopedic Stereotaxic Instrument (21 CFR 882.4560)
Regulatory Class: Class II
Product Code: OLO
Predicate Device: xvision Spine, manufactured by Augmedics Ltd. Israel (K211188)
Reference Devices:
Al-Rad Companion (Musculoskeletal), manufacture by Siemens Medical Solutions USA (K193267) ARAI Surgical Navigation System, Holo Surgical, Inc. (a subsidiary of Surgalign Spine Technologies) (K211254).
Intended Use / Indications for Use
The xvision Spine System, with xvision Spine System Software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to CT imagery of the anatomy. This can include the following spinal implant procedures:
- -Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
- -Posterior Screw Placement in C3-C7 vertebrae
- -Iliosacral Screw Placement
The Headset of the xvision Spine System displays 2D stereotaxic screens and a virtual anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient imagery. The virtual screen is indicated for displaying the virtual instrument location in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning.
4
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
Device Description
The xvision Spine (XVS) system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery. The system consists of a dedicated software, Headset, single use passive reflective markers and reusable components. It uses wireless optical tracking technology and displays to the surgeon the location of the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 2D scanned data and 3D reconstructed model, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display Headset, allowing the surgeon to both look at the patient and the navigation data at the same time.
The following modifications have been applied to the previously cleared XVS system:
The indications for use of the subject device are expanded compared to the cleared predicate device and include screw instrumentation in additional spine segments, i.e., cervical C3-C7 vertebrae and iliosacral region. Additionally, an Artificial Intelligence (AI) spine segmentation algorithm, based on Convolutional Neural Network (CNN), has been added to provide an improved virtual 3D spine model. The virtual 3D model can be built from the original CT scan or from the Al segmented CT scan. Neither of these modifications alters the intended use of the device as an aid in localization during spine surgery or its principles of operation.
Summary of Technological Characteristics
The modified xvision Spine System is similar in its technological features to its predicate device, the cleared xvision System. Both systems include very similar hardware and software components, with the following basic components: software, Headset with optical tracking camera, single use passive reflective markers, rigid reference point, and reusable tool adaptors. The Headset in both systems is positioned on the surgeon's head and is designed to provide 2D and stereoscopic 3D augmented reality (AR) display with overlaid navigation information, onto patient's anatomy. The software in both systems is designed for real time calculation and display of the spatial position of the tip of the surgical instruments relative to patient's anatomy. Both systems share the same safety features and are compatible with similar intraoperative scanners. Both systems follow similar fundamental principles of operation.
| | xvision Spine
(Subject device) | xvision Spine (K211188)
(Predicate device) | Conclusion |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The xvision Spine System,
with xvision Spine System
Software, is intended as an
aid for precisely locating
anatomical structures in
either open or percutaneous | The xvision Spine System,
with xvision Spine System
Software, is intended as an
aid for precisely locating
anatomical structures in either
open or percutaneous spine | Identical |
| | xvision Spine
(Subject device) | xvision Spine (K211188)
(Predicate device) | Conclusion |
| | spine procedures. Their use
is indicated for any medical
condition in which the use of
stereotactic surgery may be
appropriate, and where
reference to a rigid
anatomical structure, such as
the spine or pelvis, can be
identified relative to CT
imagery of the anatomy.
The Headset of the xvision
Spine System displays 2D
stereotaxic screens and a
virtual anatomy screen. The
stereotaxic screen is
indicated for correlating the
tracked instrument location to
the registered patient
imagery. The virtual screen is
indicated for displaying the
virtual instrument location in
relation to the virtual anatomy
to assist in percutaneous
visualization and trajectory
planning.
The virtual display should not
be relied upon solely for
absolute positional
information and should
always be used in
conjunction with the
| procedures. Their use is
indicated for any medical
condition in which the use of
stereotactic surgery may be
appropriate, and where
reference to a rigid anatomical
structure, such as the spine or
pelvis, can be identified
relative to CT imagery of the
anatomy.
The Headset of the xvision
Spine System displays 2D
stereotaxic screens and a
virtual anatomy screen. The
stereotaxic screen is indicated
for correlating the tracked
instrument location to the
registered patient imagery.
The virtual screen is indicated
for displaying the virtual
instrument location in relation
to the virtual anatomy to assist
in percutaneous visualization
and trajectory planning.
The virtual display should not
be relied upon solely for
absolute positional information
and should always be used in
conjunction with the displayed
stereotaxic information | |
| Indication for Use | Spinal implant procedures:
- Posterior Pedicle Screw
Placement in the thoracic
and sacro-lumbar region. - Posterior Screw
Placement in C3-C7
vertebrae - Iliosacral Screw
Placement | Spinal implant procedures,
such as Posterior Pedicle
Screw Placement in the
thoracic and sacro-lumbar
region. | Expanded
indication for use
for placing screws
in additional spine
segments.
This change does
not alter the
intended use of
the device for its
use as an aid in
localization during
spine surgery. |
| User Population | Orthopedic surgeons or
neurosurgeons | Orthopedic surgeons or
neurosurgeons | Identical |
| | xvision Spine
(Subject device) | xvision Spine (K211188)
(Predicate device) | Conclusion |
| Intended Use
Environment | Operating Room | Operating Room | Identical |
| Main system
components | • Headset with near eye
see-through display and
tracking camera
• Software application
• Flat reflective markers
• Tool adaptors
• Reference point: Patient
Clamp and Perc Pin
• Accessories: Panel PC,
Roll Stand, 8" Tablet
(Remote UI) | • Headset with near eye see-
through display and
tracking camera
• Software application
• Flat reflective markers
• Tool adaptors
• Reference point: Patient
Clamp and Perc Pin
• Accessories: Panel PC,
Roll Stand, 8" Tablet
(Remote UI) | Identical |
| Modes of
Operation | • Patient Preparation
• System Set-up
• Intraoperative scan
• Scan Import
• Patient Registration
• Navigation | • Patient Preparation
• System Set-up
• Intraoperative scan
• Scan Import
• Patient Registration
• Navigation | Identical |
| Rigid reference
point | • Patient Clamp attached to
the spinous process
• Perc Pin inserted into the
PSIS | • Patient Clamp attached to
the spinous process
• Perc Pin inserted into the
PSIS | Identical |
| Instrument (Tool)
Adaptors | • Reusable
• universal (connects to
various tools, not system-
specific)
• VP & Ergonomic (system
specific adaptors) | • Reusable
• universal (connects to
various tools, not system-
specific)
• VP & Ergonomic (system
specific adaptors) | Identical |
| Localization
Technology | Optical | Optical | Identical |
| Optical Tracker | Single infrared camera,
positioned 0.5m above
tracked objects | Single infrared camera,
positioned 0.5m above
tracked objects | Identical |
| Tracking | 6 DOF | 6 DOF | Identical |
| System Accuracy
Requirement | System Level Accuracy with
a mean 3D positional error of
2.0mm and mean trajectory
error of 2° | System Level Accuracy with a
mean positional error of
2.0mm and mean trajectory
error of 2° | Identical |
| Imaging Modality | X-Ray Based Imaging | X-Ray Based Imaging | Identical |
| | xvision Spine
(Subject device) | xvision Spine (K211188)
(Predicate device) | Conclusion |
| Medical
Device
Interfaces | O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm and RFD 3D Siemens CIOS Spin Airo system by Brainlab GE OEC 3D scanner | O-arm Imaging System Ziehm Vision FD Vario 3D C-Arm and RFD 3D Siemens CIOS Spin Airo system by Brainlab | Similar
The additional
intra-op scanner
has similar
technological
characteristics as
the other scanners
that the predicate
device is
compatible with
(i.e., DICOM
scans, resolution
and FOV). No new
questions of safety
or effectiveness
are raised |
| Display Features | 2D images: axial and sagittal
3D model
Trajectories
Trajectory guidance
Instrument's tip view
3D transparent
3D OFF (only 2D)
3D follow instrument
movement | 2D images: axial and sagittal
3D model
Trajectories
Trajectory guidance
Instrument's tip view
3D transparent
3D OFF (only 2D)
3D follow instrument
movement | Identical |
| Segmentation and
3D model
generation | Two thresholds are used to
select the input CT values
(i.e., HU) to the algorithm that
creates the 3D model, to
distinguish the spine from the
background: Threshold on the CT scan values (HU) Threshold on the AI segmented CT values that were masked as Spine. AI segmented CT values are derived from an AI based spine segmentation algorithm that is applied on the CT scan | A single threshold is used to
select the input CT values
(i.e., HU) to the algorithm that
creates the 3D model, to
distinguish the spine from the
background: Threshold on the CT scan values (HU) | Similar
In both systems
the 3D model is
created from CT
values, that are
higher than
applied threshold,
to distinguish
spine from
background.
Adding the option
to use AI spine
segmented CT
values for
improved 3D
model does not
alter the system
intended use, its
fundamental
technology or
principles of
operation. Thus, |
| | xvision Spine
(Subject device) | xvision Spine (K211188)
(Predicate device) | Conclusion |
| | | | no new safety or
effectiveness
questions are
raised.
Using Al based
algorithms for
spine
segmentation of
the reference
devices further
supports the
substantial
equivalence of this
additional feature |
| Communication
between Scanner
and
platform/computer | USB & LAN connectivity
using DICOM | USB & LAN connectivity using
DICOM | Identical |
| Display and Optics
Technology | Augmented Reality using
near eye see-through
display; data displayed on
patient's anatomy | Augmented Reality using near
eye see-through display; data
displayed on patient's
anatomy | Identical |
| Communication
between Headset
and computer | Wireless, encrypted | Wireless, encrypted | Identical |
| Supported
Frequencies &
Transmission
protocol | 2.4GHZ & 5 GHz
802.11g/n/ac | 2.4GHZ & 5 GHz
802.11g/n/ac | Identical |
| Frame rate of
displayed images | 60 fps | 60 fps | Identical |
| OE Field of View | 32.5° (vertical) X 18°
(horizontal) | 32.5° (vertical) X 18°
(horizontal) | Identical |
| Pixel resolution | 1280x720 per eye | 1280x720 per eye | Identical |
| Headset power
source | Li-ion rechargeable battery | Li-ion rechargeable battery | Identical |
| Number of
supported
Headsets | Two | Two | Identical |
A table comparing the key features of the subject and the predicate devices is provided below:
5
6
7
8
Performance Data
The following testing was conducted to evaluate the device:
9
- . The system's accuracy was validated in two cadaver studies, in which screws were positioned in C3-C7 cervical vertebrae and in the sacro-iliac segment. The positional and trajectory errors were calculated as the difference between the actual and virtual screw tip position, and the difference between the screw orientation and its recorded virtual trajectory. Additionally, clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing the post-op scans.
- . The performance of the AI segmentation algorithm was validated on a set of intra-op CT scans by comparing it with manual segmentations that were approved by US physicians. The mean Dice coefficient was calculated as the measured quality of the algorithm.
- 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 performance testing demonstrates that the xvision System performs according to specifications and functions as intended.
Conclusions
The xvision Spine System is substantially equivalent to its predicate, the cleared xvision Spine System. Both systems have the same intended use, technological characteristics, and principles of operation. The expanded indications do not alter the intended surgical use of the device and do not affect its safety and effectiveness when used as labeled. None of the minor differences in technology raise new types of safety or effectiveness questions. Performance data demonstrated that the xvision Spine system functions as intended.