(145 days)
Yes
The device description explicitly states the inclusion of a "deep learning-based spine segmentation algorithm."
No.
The device is an image-guided navigation system intended to aid surgeons in precisely locating anatomical structures during spine procedures, not to provide therapy itself.
No
Explanation: The device is described as an image-guided navigation system intended as an aid for precisely locating anatomical structures during surgery, not for diagnosing medical conditions. It uses pre-operative CT and intra-operative X-ray images to assist in screw placement and trajectory planning.
No
The device description explicitly states that the system consists of dedicated software running on a PC, a headset, single use passive reflective markers, and reusable components, indicating it includes hardware components beyond just software.
Based on the provided text, the xvision Spine System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's an "aid for precisely locating anatomical structures in either open or percutaneous spine procedures." This is 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 designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery."
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The xvision Spine System does not perform this function. It uses imaging data of the patient's anatomy to guide surgical instruments.
Therefore, the xvision Spine System falls under the category of a surgical navigation or image-guided surgery system, not an In Vitro Diagnostic device.
No
The input does not contain a specific statement that the FDA has reviewed and approved or cleared a PCCP for this device, nor does it reference any relevant text regarding a PCCP.
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 a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures:
- Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
- Posterior Screw Placement in C3-C7 vertebrae
- Iliosacral Screw Placement
- Angular procedures requiring access to the disc space
- Lateral trajectories required to access the Sacro-Iliac joint
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 (comma separated list FDA assigned to the subject device)
SBF
Device Description
The xvision Spine System (XVS) is an image-guided navigation system designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery by displaying stereoscopic augmented reality (AR) navigation onto the patient anatomy. The system consists of dedicated software running on a PC, a 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 patient's scan, onto the surgical field. The 2D 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 purpose of this 510(k) submission is to introduce a new registration algorithm that enables registering a 3D CT scan that was acquired prior to surgery (pre-operative CT) using 2D X-ray images, taken intra-operatively with a C-Arm. As part of the development of this registration method, the company developed a new software algorithm that includes a deep learning-based spine segmentation algorithm that segments individual vertebrae including the sacrum and ilium. The segmentation output is used as an input to the new registration algorithm.
The indications for use of the subject device compared to its predicate are expanded and include the use of patient's X-ray images for registration and support of angular and lateral procedures requiring access to the disc space and sacro-iliac joint. These modifications do not alter the intended purpose of the system as an aid in localization of anatomical structures during spine surgery or its principles of operation, it just enables additional inputs for registration and supports navigation in additional traiectories.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Patient's fluoroscopic or CT imagery of the anatomy, X-Ray Based Imaging
Anatomical Site
Spine, pelvis (thoracic, sacro-lumbar region, C3-C7 vertebrae, Iliosacral, disc space, Sacro-Iliac joint)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating Room, Orthopedic surgeons or neurosurgeons
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 segmentation algorithm was validated on a set of 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)
- Cleaning validation according to ANSI/AAMI ST98:2022 and shipping validation according to ISTA . 2A were performed on the new component, i.e., the Ring Adapter
- Registration accuracy and overall system accuracy were tested using phantoms, under different scenarios simulating clinical conditions. Phantom tests were performed when using the cleared registration methods and the added new registration method.
- The system's accuracy was validated in three cadaver studies in which screws were positioned in the sacro-iliac, sacro-lumbar, thoracic, and C3-C7 vertebrae levels. The positional and traiectory 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 segmentation algorithm was validated on a set of 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.
- Human Factors Usability Testing was conducted in accordance with the FDA Guidance Documents, Applying Human Factors and Usability Engineering to Medical Devices (2016) and Application of Human Factors Engineering Principles for Combination Products: Questions and Answers (2023) and IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices. Human Factors Usability Testing was conducted with intended users in a simulated use environment to ensure the user needs and intended use requirements were met.
All performance testing demonstrates that the xvision Spine System performs according to specifications and functions as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System Level Accuracy with a mean 3D positional error of 2.0mm and mean trajectory error of 2°. The mean Dice coefficient was calculated as the measured quality of the algorithm.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 16, 2024
Augmedics Ltd. % Janice M. Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K241481
Trade/Device Name: xvision Spine System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: SBF Dated: May 24, 2024 Received: September 16, 2024
Dear Janice M. 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241481
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 a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures:
- Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
- Posterior Screw Placement in C3-C7 vertebrae
- Iliosacral Screw Placement
- Angular procedures requiring access to the disc space
- Lateral trajectories required to access the Sacro-Iliac joint
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)
| ✖ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------- |
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4
510(k) Summary Augmedics'
xvision Spine System
Submitter
Augmedics Ltd. 2 Ha-Otsma St. Yokneam Illit, 2069205 Israel Phone:+972-4-3730111 Facsimile: +972-4-3730850 Contact Person: Tami Harel Date Prepared: Mav 24, 2024
Name of Device: xvision Spine System
Common or Usual Name: XVS
Classification Name: Orthopedic Augmented Reality (21 CFR 882.4560)
Regulatory Class: Class II
Product Code: SBF
Predicate Device: xvision Spine System, manufactured by Augmedics Ltd. Israel (K220905)
Reference Devices:
INTAI Surgery Navigation System, manufactured by Intai Technology Corporation (K180523).
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 a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures:
- Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
- Posterior Screw Placement in C3-C7 vertebrae
- Iliosacral Screw Placement
- Anqular procedures requiring access to the disc space
- Lateral trajectories required to access the Sacro-Iliac joint
5
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.
Device Description
The xvision Spine System (XVS) is an image-guided navigation system designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery by displaying stereoscopic augmented reality (AR) navigation onto the patient anatomy. The system consists of dedicated software running on a PC, a 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 patient's scan, onto the surgical field. The 2D 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 purpose of this 510(k) submission is to introduce a new registration algorithm that enables registering a 3D CT scan that was acquired prior to surgery (pre-operative CT) using 2D X-ray images, taken intra-operatively with a C-Arm. As part of the development of this registration method, the company developed a new software algorithm that includes a deep learning-based spine segmentation algorithm that segments individual vertebrae including the sacrum and ilium. The segmentation output is used as an input to the new registration algorithm.
The indications for use of the subject device compared to its predicate are expanded and include the use of patient's X-ray images for registration and support of angular and lateral procedures requiring access to the disc space and sacro-iliac joint. These modifications do not alter the intended purpose of the system as an aid in localization of anatomical structures during spine surgery or its principles of operation, it just enables additional inputs for registration and supports navigation in additional traiectories.
Summary of Technological Characteristics
The modified xvision Spine System is similar in its technological features to its predicate device, the cleared xvision Spine 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 the 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 the patient's anatomy. Both systems share the same safety features and follow similar fundamental principles of operation.
The modified XVS system offers an additional registration method, as an alternative to the cleared registration method using an intraoperative 3D scan. This new registration algorithm enables registering 3D scan that was taken pre-operatively with patient's anatomy using 2D X-ray images taken
6
intra-operatively. The aim of both cleared and proposed registration methods is to align the patient's anatomy with the patient's CT scan.
Additionally, the indications for use were broadened to support navigation in additional trajectories (angular and lateral procedures requiring access to the disc space and Sacro-Iliac joint). Expanding the navigation capabilities to additional trajectories, does not change the system's technological characteristics since, regardless to the angle or path of the trajectory, the aim of the system is to enable accurate navigated trajectory. Phantom and Cadaver studies were used to demonstrate that the performance of the modified XVS system meets the same acceptance criteria as the cleared device. A table comparing the key features of the subject and the predicate devices is provided below:
| | xvision Spine System
(subject device) | xvision Spine System (K220905)
(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 spine procedures | 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 | Identical |
| Indications for Use | 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 a patient's fluoroscopic or CT imagery of the anatomy. This can include the following spinal procedures:
- Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
- Posterior Screw Placement in C3-C7 vertebrae
- Iliosacral Screw Placement
- Angular procedures requiring access to the disc space
- Lateral trajectories required to access the Sacro-Iliac joint | 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 a patient's CT imagery of the anatomy. This can include the following spinal procedures:
- Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
- Posterior Screw Placement in C3-C7 vertebrae
- Iliosacral Screw Placement | Similar. The additional registration method and spinal procedures, added to the indications for use, do not constitute a new intended use. The intended use of the XVS system is as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. All added indications for use fall within this general intended use. Moreover, the added indications, do not raise different questions of safety and effectiveness, and do not significantly increase a safety or effectiveness concern previously raised by the predicate device |
| | xvision Spine System
(subject device) | xvision Spine System
(K220905)
(predicate device) | Conclusion |
| | | | Furthermore, this
change doesn't impact
the anatomical
structure, the patient
population or the clinical
context in which the
device is being used.
Hence, the proposed
change in indications for
use does not constitute
a new intended use and
a comparison to the
predicate device is still
meaningful and the
product can be
considered substantially
equivalent with respect
to Intended Use and
Indications for Use. |
| User Population | Orthopedic surgeons or
neurosurgeons | Orthopedic surgeons or
neurosurgeons | Identical |
| 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
• Computer, roll stand or
Cart
• C-ARM Ring Adapter | • Headset with near eye
see-through display and
tracking camera.
• Software application
• Flat reflective markers
• Tool adaptors
• Reference point: Patient
Clamp and Perc Pin
• Computer, roll stand | Similar
The Ring Adapter was
added to support the
new registration
method. This added
component does not
alter the intended use of
the XVS system. The
questions of accurate
beads' detection in
imaging and accurate
calculation of the spatial
position of the Ring
Adapter from the
reference frame are
common to all the
configurations of the
XVS registration
markers. Thus, adding
this component does
not raise any new
questions of safety and
effectiveness. |
| | xvision Spine System
(subject device) | Xvision Spine System
(K220905)
(predicate device) | Conclusion |
| Registration
methods | IntraOp – requiring IntraOp 3D scan (Z-link & X-link) 2D-3D (PreOp), requiring PreOp 3D CT scan and at least two IntraOp Xray images | IntraOp – requiring IntraOp 3D scan (Z-link & X-link): | Similar
Both registration methods are based on the same fundamental technology and principles of operation.
Overall system accuracy while using the 2D-3D method was verified to be comparable to the device accuracy while using the IntaOp method. Thus, no new questions of safety or efficacy are raised. The reference device (cleared under K180523) further supports the substantial equivalence of this additional registration method |
| 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 |
| Reflective
Markers | Flat Single use, provided sterile Sterilized by Gamma Radiation | Flat Single use, provided sterile Sterilized by Gamma Radiation | 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 |
| | xvision Spine System
(subject device) | xvision Spine System
(K220905)
(predicate device) | Conclusion |
| Tracking
Algorithm | Perspective N-point | Perspective N-point | 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 |
| Depp-learning
based spine
segmentation
algorithms | • Full spine anatomy
segmentation from
background
• Segmentation of single
spine vertebra | • Full spine anatomy
segmentation from
background | Similar
The single vertebra
segmentation algorithm
was added to support
the new registration
method. It does not alter
the intended use of the
system as an aid in
localization during spine
surgery. The added
algorithm is based on
the same CNN
architecture as the full
spine segmentation
algorithm.
The performance of the
single spine vertebra
algorithm was verified,
using the same metrics
(i.e., DICE coefficient),
to be comparable to the
performance of the full
spine segmentation
algorithm.
Thus, no new questions
of safety or efficacy are
raised |
| Imaging Modality | X-Ray Based Imaging | X-Ray Based Imaging | Identical |
| Medical Device
Interfaces | • O-arm Imaging System
• Ziehm Vision FD Vario 3D
C-Arm and RFD 3D
• Siemens CIOS SPin
• Airo system by Brainlab
• ExcelsiusGPS
Round C-ARMS:
GE OEC 9900 Elite, GE OEC
9800 and 9800 plus all 9" &
12" models | • O-arm Imaging System
• Ziehm Vision FD Vario
3D C-Arm and RFD 3D
• Siemens CIOS SPin
• Airo system by Brainlab
• ExcelsiusGPS | Similar
Support to C-ARM
models was added due
to adding the new
registration method.
Xray images that are
taken by these C-ARM
models, are transferred
to the XVS system.
Adding the ability to
acquire Xray images
does not alter the |
| | xvision Spine System
(subject device) | xvision Spine System
(K220905)
(predicate device) | Conclusion |
| | | | intended use of the XVs system as an aid in localization during spine surgery. Transferring Xray images to the system is similar to transferring 3D CT scans and does not raise any new questions of safety or effectiveness. |
| Display Optics
and 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 | 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 |
| Optical
Distortion |