(128 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description of the technology focuses on image processing, optical tracking, and augmented reality overlay, not AI/ML algorithms for analysis or guidance.
No
This device is a surgical guidance system that provides augmented reality visualization to aid in precisely locating anatomical structures during spinal procedures. It does not directly provide therapy or treatment to the patient.
No
This device is an image-guided navigation system intended to aid surgeons in precisely locating anatomical structures and guiding surgical procedures, not to diagnose medical conditions.
No
The device description explicitly states that the system consists of software running on the Microsoft Hololens 2 headset, image visible ARTags (AprilTags), and a pre-operative planning workstation, indicating the inclusion of hardware components beyond just the software itself.
Based on the provided information, the VisAR System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- VisAR System's Function: The VisAR System is an image-guided navigation system used during surgical procedures. It uses pre-operative CT images and optical tracking to overlay virtual anatomical information and instrument locations onto the patient's body in real-time. Its purpose is to aid in the precise location of anatomical structures and guide surgical instrument placement.
- No Specimen Analysis: The system does not analyze any biological specimens from the patient. It works with imaging data and the physical anatomy of the patient.
Therefore, the VisAR System falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or iliac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
VisAR displays a virtual screen for stereoscopic 3D images acquired from CT sources. It is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the anatomy of the patient in order to support intraoperative analysis and guidance.
The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in visualization and trajectory planning for both open and percutaneous surgeries.
Product codes
OLO, LLZ
Device Description
The VisAR system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous spinal surgery. The system consists of Novarad's immersive augmented reality software running on the Microsoft Hololens 2 headset, image visible ARTags (AprilTags), a pre-operative planning workstation and the Novarad PACS server. It uses optical tracking technology to co-localize the virtual 3D image datasets to the patient and displays to the surgeon the location of pre-operatively planned operative tracks and the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 3D scanned image, along with tracking information, are projected to the surgeons' retina using a transparent near-eye-display stereoscopic headset, allowing the surgeon to both look at the navigation data at the same time.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT sources
Anatomical Site
Spine, iliac crests, thoracic and sacro-lumbar region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical professionals, including surgeons, in healthcare settings such as hospitals, clinics, and procedure rooms. Specifically, the Operating Room for the subject device.
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
Bench testing was performed on 7 cadavers. 124 pedicle screws were positioned using VisAR augmented reality navigation/guidance. The angular error and distance error were calculated.
Following CT, the pedicle entry point, trajectory, and depth were determined and annotated using NovaPACS software (Novarad, Provo, Utah) by a neuroradiologist. The annotated images were uploaded to VisAR and transformed to 3D images for surgical guidance. Spine surgeons used VisAR as the guidance device for pedicle screw insertion. The preoperative CT was fused with the postoperative CT and spatial locations of both the annotated virtual pathway and the actual screw placement were determined with vector coordinates.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy Testing:
- Study Type: Bench testing.
- Sample Size: 7 cadavers, 124 pedicle screws.
- Key Results:
- Overall Mean Positional Error: 1.9 mm (STD: 0.9 mm)
- Overall Mean Trajectory Angle Error: 2.4 degrees (STD: 1.2 degrees)
- Pedicle Screw Positioning Accuracy (Gertzbein-Robbins Scale): 96% of pedicle screws were placed correctly (grades A and B).
- A: No breach - 113
- B: 0-2 mm - 6
- C: 2.1-4.0 mm - 5
- D: 4.1-6.0 mm - 0
- E: >6.0 mm - 0
- Standalone Performance: The system demonstrated performance in 3D positional accuracy with a mean error lower than 3mm and in trajectory angle accuracy with a mean error lower than 3 degrees, in phantom and cadaver studies.
Additional Performance Testing:
- Performance of the Headset display (Field of View, resolution, luminance, transmittance, distortion, contrast ratio, temporal, display noise and motion-to-photon latency) was verified.
- User Needs validation performed in cadaver labs and simulated use tests.
- Electrical safety tested in accordance with ANSI AAMI ES60601-1.
- Electromagnetic Compatibility tested in accordance with IEC 60601-1-2:2014.
- Sterilization validation for single use components in accordance with ANSI/AAMI/ISO 11137-1.
- Shelf life and packaging testing.
- Reusable components validated for cleaning and sterilization per manufacturer instructions.
- Headset cleaning and disinfection performed according to FDA guidance.
- Biocompatibility of all patient contact materials verified according to ISO 10993-1:2018 and FDA guidance.
- Software verification and validation testing conducted as required by IEC 62304:2015.
- Human factors and usability testing conducted as required by IEC 62366-1:2015+AMD1:2020.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Mean Positional Error: 1.9 mm (STD: 0.9)
Overall Mean Trajectory Angle Error: 2.4 degrees (STD: 1.2 degrees)
96% of the pedicle screws were placed correctly (grades A and B) when graded with the Gettzbein-Robbins scale.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the date May 27, 2022. The month is May, the day is 27, and the year is 2022. The date is written in a clear, sans-serif font. The text is black against a white background.
U.S. FOOD & DRUG
ADMINISTRATION
Novarad Corporation Doug Merrill Compliance Manager 3152 North University Avenue, Suite 200 Provo. Utah 84604
Re: K220146
Trade/Device Name: VisAR Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: April 28, 2022 Received: April 28, 2022
Dear Doug Merrill:
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
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, 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) K220146
Device Name VisAR
Indications for Use (Describe)
The VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or iliac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
VisAR displays a virtual screen for stereoscopic 3D images acquired from CT sources. It is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the anatomy of the patient in order to support intraoperative analysis and guidance.
The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in visualization and trajectory planning for both open and percutaneous surgeries.
| 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
K220146 510(K) SUMMARY
Submitter
Novarad Corporation 3152 North University Avenue, Suite 200 Provo, UT 84604 E-mail: doug.merrill(@novarad.net Phone: 801-642-1001 Contact Person: Doug Merrill Date Summary Prepared: 21 December 2021
Device Name
Trade Name: VisAR
Common or Usual Name: Stereotaxic Guidance System and Imaging Software
Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: 21 CFR 882.4560
Regulatory Class: Class II
Product Code: OLO and LLZ
Primary Predicate Device
| K190929 | xvision Spine system (XVS) | Augmedics Ltd. |
|---|---|---|
| --------- | ---------------------------- | ---------------- |
Additional Predicate Device
| K172418 | OpenSight | Novarad Corporation |
|---|---|---|
| --------- | ----------- | --------------------- |
Device Description
The VisAR system is an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous spinal surgery. The system consists of Novarad's immersive augmented
4
reality software running on the Microsoft Hololens 2 headset, image visible ARTags (AprilTags), a pre-operative planning workstation and the Novarad PACS server. It uses optical tracking technology to co-localize the virtual 3D image datasets to the patient and displays to the surgeon the location of pre-operatively planned operative tracks and the tracked surgical instruments relative to the acquired intraoperative patient's scan, onto the surgical field. The 3D scanned image, along with tracking information, are projected to the surgeons' retina using a transparent near-eyedisplay stereoscopic headset, allowing the surgeon to both look at the navigation data at the same time.
Indication for Use
The VisAR System is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. VisAR is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, and where reference to at least one rigid anatomical structure, such as the spine or illac crests, can be identified relative to CT imagery of the anatomy. This can include guidance for procedures, such as Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region.
VisAR displays a virtual screen for stereoscopic 3D images acquired from CT sources. It is intended to enable users to segment previously acquired 3D datasets, overlay, and register these 3D segmented datasets with the anatomy of the patient in order to support intraoperative analysis and guidance.
The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assust in visualization and trajectory planning for both open and percutaneous surgeries.
Summary of Technological Characteristics
The VisAR System is similar in its technological features to its primary predicate device, the xvision Spine System (K190929). Both systems are intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures and both systems consist of similar types of components and involve similar principles of operation. Both systems retrieve and display images from DICOM compliant medical imaging modalities and/or systems. They are intended to be used in healthcare settings, such as hospitals, clinics, and procedure rooms. They are intended to provide qualified medical professionals with a variety of tools and software features for the viewing, analysis, and annotation of medical images. Both systems includes a see-through near eve display headset, which is positioned on the surgeon's head, for displaying overlaid navigation information of stereoscopic 3D images from DICOM compliant medical imaging modalities onto patient's anatomy.
The VisAR System is similar in its technological features to predicate device OpenSight (K172418) although this device has been previously cleared for pre-operative use only.
There are no clinical tests to compare VisAR and predicate device system (XVS), as they are software products that retrieve and display images and information.
There are minor differences between the subject and predicate devices; however, these differences do not raise different questions of safety or effectiveness when compared to the primary predicate device. Both systems utilize stereotaxic technologies within the same surgical workflow. Minor differences in the optical tracking systems, display features, and medical device interfaces are addressed by performance testing.
A table comparing the key features of the subject and the predicate devices is provided below:
5
| Item | Subject Device
VisAR | Predicate Device
(primary)
xvision Spine system (XVS)
K190929 | Predicate Device
OpenSight
K172418 | Comments |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Intended Use /
Indidcations for
Use | The VisAR System is
intended as an aid for
precisely locating
anatomical structures in
either open or percutaneous
spine procedures. VisAR is
indicated for any medical
condition in which the use
of stereotaxic surgery may
be appropriate, and where
reference to at least one
rigid anatomical structure,
such as the spine or iliac
crests, can be identified
relative to CT imagery of
the anatomy. This can
include guidance for
procedures, such as
Posterior Pedicle Screw
Placement in the thoracic
and sacro-lumbar region.
VisAR displays a virtual
screen for stereoscopic 3D
images acquired from CT
sources. It is intended to
enable users to segment
previously acquired 3D
datasets, overlay, and
register these 3D segmented
datasets with the anatomy
of the patient in order to
support intraoperative
analysis and guidance.
The virtual screen is
indicated for displaying the
virtual instrument location
in relation to the virtual
anatomy to assist in
visualization and trajectory
planning for both open and
percutaneous surgeries. | 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, 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 | 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 pre-operative
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 | Equivalent |
| | | and should always be
used in conjunction with
the displayed stereotaxic
information. | to better understand
anatomy and pathology
of patient. | |
| Intended Use
Environment | Operating Room | Operating Room | Healthcare
settings, such as
hospitals and
clinics | Equivalent |
| Main System
Components | - Headset with near eye see-
through display and
tracking camera
- Software application
- Image visible ARTags
(AprilTags) - Optical tracking
technology | - Headset with near eye
see-through display
and tracking camera - Software application
- Reflective markers-Flat
- Instrument universal
Adaptors - Reference point | - Headset with near
eye see-through
display and tracking
camera - Software application
- Optical tracking
technology | Utilizes the
same process |
| Modes of
Operation | - Patient Preparation - System Set-up
- Preoperative scan
- Preoperative planning
- Intraoperative scan
- Scan Import
- Patient Registration
- Navigation | - Patient Preparation
- System Set-up
- Intraoperative scan
- Scan Import
- Patient Registration
- Navigation | - System Set-up
- Preoperative scan
- Preoperative planning
- Scan Import
- Patient Registration | Equivalent |
| Localization
Technology | Optical | Optical | Mesh surface maps | Equivalent |
| Optical Tracker | Has 3d sensors, and
cameras for detecting the
environment | Single infrared camera,
positioned 0.5m above
tracked objects | Has 3d sensors, and
cameras for detecting
the environment | Equivalent |
| Tracking | 6 DOF | 6 DOF | 6 DOF | Equivalent |
| Tracking
Algorithm | Perspective N-point
followed by center ray
optimization | Perspective N-point | Not relevant | Equivalent |
| System Accuracy
Requirement | System Level Accuracy
with a mean positional
error of 3.0mm and mean
trajectory error of 3° | System Level Accuracy
with a mean positional
error of 2.0mm and
mean trajectory error of
2° | Not relevant | Equivalent to
Orthopedic
requirement |
| Imaging Modality
/ Data Sources | CT sources | X-Ray Based Imaging | CR, DX, CT, MR, and
PT sources | Equivalent |
| Medical Device
Interfaces | Pre-operative planning
workstation
Novarad PACS server | O-arm Imaging System
Ziehm Vision FD Vario
3D
C-Arm and RFD 3D | Pre-operative planning
workstation
Novarad PACS server | Utilizes the
same process |
| | | Siemens CIOS SPin
Airo system by Brainlab | | |
| Display Features | 2D images: axial, sagittal,
coronal and oblique
3D real time rendering
Trajectories
Trajectory guidance
Instrument's tip view
3D transparent | 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,
sagittal, coronal and
oblique
3D or 4D real time
rendering
Trajectories
3D transparent
3D OFF (only 2D) | Equivalent -
VisAR does
not use a 3D
model |
| Software Interface
(GUI) | Multiple heads up menu
displays
Voice controls
Hand gestures | 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 | Multiple heads up
menu displays
Voice controls
Hand gestures | Equivalent |
| Communication
between Scanner
and
platform/computer | WiFi communication with
Novorad server, provides
medical scan | USB & LAN
connectivity using
DICOM | WiFi communication
with Novorad server,
provides medical scan | Equivalent |
| 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 | Augmented Reality
using near eye see-
through display; data
displayed on patient's
anatomy | Equivalent |
| Communication
between Headset
and computer | Wireless, encrypted | Wireless, encrypted | Wireless, encrypted | Equivalent |
| Frame rate of
displayed images | 60 fps | 60 fps | 60 fps | Equivalent |
| Headset power
source | Li-ion rechargeable battery | Li-ion rechargeable
battery | Li-ion rechargeable
battery | Equivalent |
6
7
Performance Data
The following testing was conducted to evaluate the device:
. Accuracy
Bench testing was performed on 7 cadavers. 124 pedicle screws were positioned using VisAR augmented reality navigation/guidance. The angular error and distance error were calculated.
Following CT, the pedicle entry point, trajectory, and depth were determined and annotated using NovaPACS software (Novarad, Provo, Utah) by a neuroradiologist. The annotated images were uploaded to VisAR and transformed to 3D images for surgical guidance. Spine surgeons used VisAR as the guidance device for pedicle
8
screw insertion. The preoperative CT was fused with the postoperative CT and spatial locations of both the annotated virtual pathway and the actual screw placement were determined with vector coordinates.
The following tables summarize the results:
Overall Positional Error:
| Registration
Method | Mean Overall
Positional
Error [mm] | STD Overall
Positional
Error [mm] | 99%
Upper Bound Limit
Overall Positional
Error [mm] |
|------------------------------------------------------|------------------------------------------|-----------------------------------------|--------------------------------------------------------------|
| Optical Codes
(ARTags,
AprilTags)
alignment | 1.9 | 0.9 | 1.85-1.94 |
Overall Trajectory Angle Error:
| Mean Overall
Trajectory Angle
Error (deg) | STD Overall
Trajectory Angle
Error (deg) | 99%
Upper Bound Limit
Overall Trajectory Angle
Error (deg) |
|-------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------|
| 2.4 | 1.2 | 2.35-2.44 |
● Pedicle Screw Positioning Accuracy: Gertzbein-Robbins Scale1
Screw placement was also evaluated with the Gertzbein-Robbins scale, which is the clinical measurement of pedicle screw placement accuracy.
| Gertzbein-Robbins Scale | Grades of pedicle screws
positioned in 3 cadavers |
|-------------------------|------------------------------------------------------|
| A: No breach | 113 |
| B: 0-2 mm | 6 |
| C: 2.1-4.0 mm | 5 |
| D: 4.1-6.0 mm | 0 |
| E: >6.0 mm | 0 |
Accuracy Summary: ●
The overall mean positional error is 1.9 mm (STD: 0.9), with an angle of error of 2.4 degrees (STD: 1.2 degrees). 96% of the pedicle screws were placed correctly (grades A and B) when graded with the Gettzbein-Robbins scale.
9
The system has demonstrated performance in 3D positional accuracy with a mean error lower than 3mm and in trajectory angle accuracy with a mean error lower than 3 degrees, in phantom and cadaver studies.
- Performance of the Headset display was demonstrated by verifying the following elements: Field of View . (FOV), resolution, luminance, transmittance, distortion, contrast ratio, temporal, display noise and motion-tophoton 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, 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 disturbances - Requirements and tests.
- Sterilization validation for the single use components was conducted in accordance with the ● ANSI/AAMI/ISO 11137-1, Sterilization of health care products-Radiation-Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. Additionally, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
- Reusable components are validated for cleaning and sterilization per manufacturer instructions. ●
- Headset cleaning and disinfection vas performed according to 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, September 4, 2020. All tests were successfully completed.
- Software verification and validation testing was conducted as required by IEC 62304:2015, Medical Device ● Software - Software Lifecycle processes.
- . Human factors and usability testing was conducted as reguired by IEC 62366-1:2015+AMD1:2020, Medical devices - Part 1: Application of usability engineering to medical devices.
All performance testing demonstrates that the VisAR System performs according to specifications as intended.
Conclusions
The information provided above supports that the VisAR System is substantially equivalent to the identified predicate devices. Substantial equivalence has been demonstrated through a comparison of
10
intended use, technological characteristics, as well as performance evaluations. 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 VisAR System functions as intended without raising new safety or effectiveness concerns. The VisAR System can be considered substantially equivalent to the identified predicate devices.
1 S. D. Gertzbein and Stephen E. Robbins. Accuracy of pedicular screw placement in vivo. Spine, 15:1:11-14, 1990.