(255 days)
OpenSight, K172418
No
The summary does not mention AI, ML, deep learning, or any related terms, and the description focuses on image-guided navigation using optical tracking and display technology.
No
Explanation: The device is an image-guided navigation system intended as an aid for precisely locating anatomical structures during spine procedures, not for direct therapeutic treatment.
No
The device is described as an image-guided navigation system that aids in precisely locating anatomical structures and placing surgical instruments during spine procedures. Its intended use is to assist in surgical procedures, not to diagnose a medical condition.
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, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "aid for precisely locating anatomical structures in either open or percutaneous spine procedures." This describes a surgical navigation system used during a medical procedure on a patient.
- Device Description: The description reinforces this by stating it's an "image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery." It uses tracking technology and displays information to the surgeon during the procedure.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
This device does not examine specimens from the human body in vitro. It is a surgical tool used in vivo (within the living body) to guide surgical procedures.
N/A
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, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray Based Imaging
Anatomical Site
Spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Not Found
Summary of Performance Studies
Bench testing was conducted to demonstrate that the xvision-Spine system performs according to its requirements and specifications. Overall system accuracy, image registration accuracy and tracking accuracy were tested using phantoms, under different conditions simulating clinical conditions such as: Headset mounted statically and Headset moving above the markers, different distances between the Headset and the markers, and different angles. The XVS system supports a Z-link patient registration method that uses a known mechanical position between the registration marker and the rigid reference marker. The Z-link method uses two optional Z markers to accommodate for different patients' size. Under all test conditions, the overall average image registration error was 1.103 mm or less.
Overall Positional Error:
Z-link (Z1 marker), Static Headset: Mean Overall Positional Error [mm] 0.932, STD Overall Positional Error [mm] 0.657, 99% UBL* Overall Positional Error [mm] 1.105
Z-link (Z1 marker), Moving Headset: Mean Overall Positional Error [mm] 0.954, STD Overall Positional Error [mm] 0.631, 99% UBL* Overall Positional Error [mm] 1.12
Z-link (Z2 marker), Static Headset: Mean Overall Positional Error [mm] 0.715, STD Overall Positional Error [mm] 0.542, 99% UBL* Overall Positional Error [mm] 0.857
Z-link (Z2 marker), Moving Headset: Mean Overall Positional Error [mm] 0.63, STD Overall Positional Error [mm] 0.54, 99% UBL* Overall Positional Error [mm] 0.772
Overall Trajectory Angle Error:
Static Headset: Mean Overall Trajectory Angle Error [deg] 0.468, STD Overall Trajectory Angle Error [deg] 0.162, 99% UBL* Overall Trajectory Angle Error [deg] 0.589
Moving Headset: Mean Overall Trajectory Angle Error [deg] 0.683, STD Overall Trajectory Angle Error [deg] 0.44, 99% UBL* Overall Trajectory Angle Error [deg] 1.08
Additionally, tracking accuracy was verified per ASTM F2554-10.
The System's accuracy was also validated in a cadaver study, in which pedicle screws were positioned percutaneously in thoracic and sacro-lumbar vertebrae. The positional error was calculated as the difference between the actual screw tip position, derived from the post-op scan, and its planned/virtual tip, as recorded by the xvision-Spine system. The trajectory error was calculated as the difference between the screw orientation and its recorded planned/virtual trajectory. The following positional and trajectory angle errors were demonstrated:
XVS system: Positional Error [mm] Mean 1.98, Standard Deviation 0.90, 99% UBL* 2.22; Trajectory Angle Error [deg] Mean 1.3, Standard Deviation 0.65, 99% UBL* 1.47
Thus, the system has demonstrated performance in 3D positional accuracy with a mean error statistically significantly lower than 3mm and in trajectory angle accuracy with a mean error statistically significantly lower than 3 degrees, in phantom and cadayer studies.
Performance of the Headset display was demonstrated by verifying the following elements: Field of View (FOV), resolution, luminance, transmission, distortion, contrast ratio, polarization, location of the virtual image plane and latency.
User Needs validation - The system was validated with intended users in cadaver labs and 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.
Electrical safety, Electromagnetic Compatibility (EMC), Sterilization validation for the single use components, Reusable components validation for cleaning and steam sterilization, Headset cleaning and disinfection validation, and Biocompatibility testing were performed.
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 Spine System performs according to specifications and functions as intended.
Key Metrics
Bench testing:
Overall Positional Error (mean): 0.63 mm - 0.954 mm
Overall Trajectory Angle Error (mean): 0.468 deg - 0.683 deg
Cadaver study:
Positional Error (mean): 1.98 mm
Trajectory Angle Error (mean): 1.3 deg
Predicate Device(s)
StealthStation S8 Spine Software V1.0.0, manufactured by Medtronic Navigation, USA (K170011)
Reference Device(s)
OpenSight, manufactured by Novarad Corporation, USA, (K172418)
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
December 20, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Augmedics Ltd. % Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K190929
Trade/Device Name: xvision Spine system (XVS) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 16, 2019 Received: December 16, 2019
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.
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
1
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 (OS) 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,
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
510(k) Number (if known) K190929
Device Name
xvision Spine (XVS) 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, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
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 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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K190929
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: December 20, 2019
Name of Device: xvision Spine
Common or Usual Name: XVS
Classification Name: Orthopedic Stereotaxic Instrument (21 CFR 882.4560)
Regulatory Class: Class II
Product Code: OLO
Predicate Devices
StealthStation S8 Spine Software V1.0.0, manufactured by Medtronic Navigation, USA (K170011)
Reference Devices
OpenSight, manufactured by Novarad Corporation, USA, (K172418)
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.
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
4
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, can be identified relative to CT imagery of the anatomy. This can include the spinal implant procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
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.
Summary of Technological Characteristics
The xvision Spine System is similar in its technological features to its predicate device, the StealthStation S8 Spine Software V1.0.0 (K170011). Both systems are intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures and both systems consist of similar types of components and involve similar principles of operation. Both systems use optical infrared camera(s) to track the position of the surgical instruments in relation to the surgical anatomy. A rigid reference point representing patient's anatomy, is connected to patient's anatomy throughout the procedure, in both systems. Additionally, in both the subject and predicate device, tool adaptors are used for affixing the tracked reflective markers to the surgical instruments. The xvision Spine system includes a Headset, which 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. In the predicate system, this navigation information is displayed on a monitor, which is part of the system's cart and is positioned to the side or in front of the surgeon. The use of a headset for presenting stereoscopic augmented reality (AR) display of patient's anatomy is not a new feature and has been previously cleared under K172418 for the OpenSight (reference device), although this device is not cleared to be used for intraoperative use. Similarly to the xvision Spine Headset, the reference device uses a see-through near eye display (Microsoft HoloLens) for displaying superimposed information of 2D images and 3D holograms from DICOM compliant medical imaging modalities onto patient's anatomy.
A table comparing the key features of the subject and the predicate devices is provided below:
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| | xvision Spine | StealthStation (K170011)
[predicate device] | OpenSight (K172418)
[reference device] |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use /
Indications for
Use | The xvision Spine System,
with xvision Spine
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, can be
identified relative to CT
imagery of the anatomy.
This can include the spinal
implant procedures, such
as Posterior Pedicle Screw
Placement in the thoracic
and sacro-lumbar region.
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. | The StealthStation System,
with StealthStation Spine
Software, is intended as an
aid for precisely locating
anatomical structures in
either open or
percutaneous neurosurgical
and orthopedic 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
images of the anatomy.
This can include the
following spinal implant
procedures, such as:
• Pedicle Screw Placement
• Iliosacral Screw
Placement
• Interbody Device
Placement | OpenSight is intended to
enable users to display,
manipulate, and evaluate 2D,
3D, and 4D digital images
acquired from CR, DX, CT,
MR, and PT sources. It is
intended to visualize 3D
imaging holograms of the
patient, on the patient, for
preoperative localization and
pre-operative planning of
surgical options. OpenSight is
designed for use only with
performance-tested hardware
specified in the user
documentation.
OpenSight is intended to
enable users to segment
previously acquired 3D
datasets, overlay, and register
these 3D segmented datasets
with the same anatomy of the
patient in order to support pre-
operative analysis.
OpenSight is not intended for
intraoperative use. It is not to
be used for stereotactic
procedures.
OpenSight is intended for use
by trained healthcare
professionals, including
surgeons, radiologists,
chiropractors, physicians,
cardiologists, technologists,
and medical educators. The
device assists doctors to
better understand anatomy
and pathology of patient |
| Intended Use
Environment | Operating Room | Operating Room | Healthcare
settings, such as hospitals and
clinics |
| | xvision Spine | StealthStation (K170011)
[predicate device] | OpenSight (K172418)
[reference device] |
| Main system
components | Headset with near eye
see-through display and
tracking camera Software application Reflective markers-Flat Instrument universal
adaptors Reference point | Platform including cart,
computer, monitor and
tracking cameras Software application Reflective markers -
Spheres Accessories (Instrument
adaptors, referencing
system) | Headset with near eye see-
through display Software application |
| Modes of
Operation | Patient Preparation System Set-up Intraoperative scan Scan Import Patient Registration Navigation | Patient Preparation System Set-up Intraoperative scan Scan Import Planning Patient Registration Navigation | System Set-up Scan import Patient Registration |
| Localization
Technology | Optical | Optical | Time of flight |
| Optical Tracker | Single infrared camera,
positioned 0.5m above
tracked objects | Two infrared cameras,
positioned 2-3m away from
tracked objects | No tracking- spatial mapping
provides a representation of
real-world surfaces around
the device |
| Tracking | 6 DOF | 6 DOF | No tracking- spatial mapping
provides a representation of
real-world surfaces around
the device |
| Tracking
Algorithm | Perspective N-point | Triangulation | No tracking- spatial mapping
provides a representation of
real-world surfaces around
the device |
| System Accuracy
Requirement | System Level Accuracy
with a mean 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° | Not relevant |
| Imaging Modality | X-Ray Based Imaging | X-Ray Based Imaging | CR, DX, CT, MR, and PT |
| Medical Device
Interfaces | O-arm Imaging System
Ziehm Vision FD Vario 3D
C-Arm and RFD 3D
Siemens CIOS SPin
Airo system by Brainlab | O-arm Imaging System
Ziehm Vision FD Vario 3D
C-Arm
ISO-C 3D C-Arm
Orbic 3D C-Arm | The system does not interface
directly with the imaging
modality |
| | xvision Spine | StealthStation (K170011) | OpenSight (K172418) |
| | | [predicate device] | [reference device] |
| 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 | Look Sideways
3D
Anatomic Orthogonal
Trajectory 1 and 2
Trajectory Guidance
Look Ahead
Probe's Eye
AP and Lateral
Synthetic AP and Lateral
Maximum Intensity
Projection
Video Input | Not reported |
| Software Interface
(GUI) | Black and blue style with
procedure task overview in
a menu and next/back task
flow. Software controls for
images, instrument and
planned trajectory
management | Black and gray style with
procedure task overview in
left menu option and
next/back task flow at
bottom of the screen.
Software controls for
images, planning and
instrument management
are contained in a right side
bar. | Software controls for window
level, segmentation and
rendering, registration, motion
correction, virtual tools (i.e,
lines, distance & volume
measurements) alignment,
measure image intensity
values, such as
standardized uptake value. |
| Communication
between Scanner
and
platform/computer | USB & LAN connectivity
using DICOM | Network Connectivity
CD, DVD, USB
DICOM Import
DICOM Export | WiFi communication with
Novorad server, not a
scanner |
| Display and
Optics
Technology | Augmented Reality using
near eye see-through
display; data displayed on
patient's anatomy | Data displayed on a
monitor | Augmented Reality using
near eye see-through
display; data displayed on
patient's anatomy |
| Communication
between Headset
and computer | Wireless, encrypted | No Headset | Wireless, encrypted |
| Frame rate of
displayed images | 60 fps | Not reported | 60 fps |
| Headset power
source | Li-ion rechargeable battery | No Headset | Researchable battery |
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7
Performance Data
The following testing was conducted to evaluate the device:
- . Bench testing was conducted in order to demonstrate that the xvision-Spine system performs according to its requirements and specifications. In particular, overall system accuracy, image registration accuracy and tracking accuracy were tested using phantoms, under different conditions simulating clinical conditions such as: Headset mounted statically and
8
Headset moving above the markers, different distances between the Headset and the markers, and different angles. The XVS system supports a Z-link patient registration method uses a known mechanical position between the registration that marker and the rigid reference marker. The Z-link method uses two optional Z markers to accommodate for different patients' size. Under all test conditions, the overall average image registration error was
1.103 mm or less. The following tables summarize the performance results demonstrated on phantoms:
| Registration Method | Headset | Mean Overall
Positional
Error [mm] | STD Overall
Positional
Error [mm] | 99%
UBL*
Overall
Positional
Error [mm] |
|---------------------|----------------|------------------------------------------|-----------------------------------------|----------------------------------------------------|
| Z-link (Z1 marker) | Static Headset | 0.932 | 0.657 | 1.105 |
| | Moving Headset | 0.954 | 0.631 | 1.12 |
| Z-link (Z2 marker) | Static Headset | 0.715 | 0.542 | 0.857 |
| | Moving Headset | 0.63 | 0.54 | 0.772 |
Overall Positional Error:
Overall Trajectory Angle Error:
| Headset | Mean Overall
Trajectory Angle
Error [deg] | STD Overall
Trajectory Angle
Error [deg] | 99% UBL* Overall
Trajectory Angle
Error [deg] |
|----------------|-------------------------------------------------|------------------------------------------------|-----------------------------------------------------|
| Static Headset | 0.468 | 0.162 | 0.589 |
| Moving Headset | 0.683 | 0.44 | 1.08 |
*UBL (Upper Bound Limit)
Additionally, tracking accuracy was verified per ASTM F2554-10.
- . The System's accuracy was also validated in a cadaver study, in which pedicle screws were positioned percutaneously in thoracic and sacro-lumbar vertebrae. The positional error was calculated as the difference between the actual screw tip position, derived from the post-op scan, and its planned/virtual tip, as recorded by the xvision-Spine system. The trajectory error was calculated as the difference between the screw orientation and its recorded planned/virtual trajectory. The following positional and trajectory angle errors were demonstrated:
| Performance
| validation | Positional Error [mm] | Trajectory Angle Error [deg] | ||||
|---|---|---|---|---|---|---|
| Mean | Standard | |||||
| Deviation | 99% | |||||
| UBL* | Mean | Standard | ||||
| Deviation | 99% | |||||
| UBL* | ||||||
| XVS system | 1.98 | 0.90 | 2.22 | 1.3 | 0.65 | 1.47 |
*UBL (Upper Bound Limit)
9
Thus, the system has demonstrated performance in 3D positional accuracy with a mean error statistically significantly lower than 3mm and in trajectory angle accuracy with a mean error statistically significantly lower than 3 degrees, in phantom and cadayer studies,
- . Performance of the Headset display was demonstrated by verifying the following elements: Field of View (FOV), resolution, luminance, transmission, distortion, contrast ratio, polarization, location of the virtual image plane and latency.
- User Needs validation - The system was validated with intended users in cadaver labs and 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.
- Electrical safety was tested in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and . A1:2012,C1:2009/(R)2012 and A2:2010/(R)2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . Electromagnetic Compatibility (EMC) was tested in accordance with IEC 60601-1-2:2014 -Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- . Sterilization validation for the single use components was conducted in accordance with the ANSI AAMI ISO 11137-1:2006/(R)2010. Additionally, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
- . Reusable components were validated for cleaning, in accordance with the AAMI TIR30:2011 guidance, and for steam sterilization, in compliance with the partial cycle validation approach outlined in ANSI/AAMI/ISO 17665-1:2006/(R)2013 and the validation approach outlined in ANSI/AAMI/ISO 14937:2009/(R)2013.
- . Headset cleaning and disinfection validation was performed according to AAMI TIR 30:2011/(R)2016, AAMI TIR 12:2010, and FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff " (March 17, 2015).
- The biocompatibility of all patient contact materials was verified according to ISO 10993-1:2018 and FDA guidance on the use of ISO 10993-1, June 16, 2016. All tests were successfully completed.
- 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 Spine System performs according to specifications and functions as intended.
10
Conclusions
The xvision Spine System is substantially equivalent to the StealthStation S8 Spine Software V1.0.0. The xvision Spine has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended surgical use of the device and do not affect its safety and effectiveness when used as labeled. Performance data demonstrated that the xvision Spine system functions as intended without raising new safety or effectiveness questions.