(263 days)
StealthStation S8 Spine Software V1.0.0 (K170011)
Yes
The summary mentions "autonomous spine segmentation process performed by the ARAI Spine Software" and describes testing this process by comparing it to manual segmentations using the Sørensen-Dice coefficient, which is a common metric used to evaluate the performance of segmentation algorithms, often including those based on ML. While the terms AI/ML are not explicitly used in the "Mentions AI, DNN, or ML" section, the description of an "autonomous" segmentation process and the method of evaluating its performance strongly suggest the use of AI/ML techniques for image analysis.
No
The device is a surgical navigation system that aids in precisely locating anatomical structures and provides guidance during orthopedic procedures; it does not directly treat or cure a disease or condition.
No.
The device is described as a surgical navigation system that provides visualization and guidance during orthopedic procedures, not for diagnosing medical conditions.
No
The device description explicitly states that the ARAI™ System is a "combination of hardware and software" and lists several hardware components including mobile devices, a display unit, an augmented reality visor (optional), a control workstation, and an optical navigation tracker with infrared cameras and lights.
Based on the provided information, the ARAI™ System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is an aid for precisely locating anatomical structures in vivo (within the body) during surgical procedures. IVD devices are used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a surgical navigation system that uses hardware and software to visualize internal anatomy and provide guidance during surgery. This is consistent with a surgical device, not an IVD.
- Input Imaging Modality: The system uses intraoperative CT images, which are acquired directly from the patient's body during surgery. IVD devices typically analyze samples obtained from the patient.
- Anatomical Site: The system is used on the lumbosacral spine region, which is an internal anatomical site.
- Performance Studies: The performance studies focus on surgical accuracy (positional and angular error of instruments relative to anatomy) and system performance in a surgical setting, not on the analysis of biological samples.
The ARAI™ System is a surgical navigation system designed to assist surgeons during orthopedic procedures. It does not perform diagnostic tests on biological specimens outside the body, which is the defining characteristic of an IVD.
No
The provided text does not contain explicit language stating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy.
The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.
Product codes (comma separated list FDA assigned to the subject device)
OLO, LLZ
Device Description
The ARAI™ System is a combination of hardware and software that provides visualization of the patient's internal boney anatomy and surgical guidance to the surgeon based on registered patient-specific digital imaging.
ARAI™ is a navigation system for surgical planning and/or intraoperative guidance during stereotactic surgical procedures. The ARAI™ system consists of two mobile devices: 1) the surgeon workstation, which includes the display unit and the augmented reality visor (optional), and 2) the control workstation, which houses the optical navigation tracker and the computer. The optical navigation tracker utilizes infrared cameras and active infrared lights to triangulate the 3D location of passive markers attached to each system component to determine their 3D positions and orientations in real time. The 3D scanned data is displayed with both 2D images and 3D virtual models along with tracking information on computer mounted on workstations near the patient bed and a dedicated projection display mounted over the patient. Augmented reality is accomplished with the 3D virtual models being viewed with dedicated headset(s).
Software algorithms combine tracking information and high-resolution 3D anatomical models to display representations of patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
intraoperative CT images of the anatomy.
intraoperative 3D scanner images
Anatomical Site
lumbosacral spine region
lumbosacral spine
spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
A set of test samples presenting lumbosacral spine, extracted from stationary and intraoperative Computed Tomography scans was subjected to the autonomous spine segmentation process performed by the ARAI Spine Software. The quality of the autonomous anatomical segmentation applied by the ARAI Surgical Navigation System was determined by comparing it with manual segmentations prepared by trained analysts based on mean Sørensen-Dice coefficient (DSC) calculations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing was conducted on ARAI™ Surgical Navigation System to confirm that the device meets performance requirements under the indications for use and to ensure equivalent safety and efficacy of the system to the cited predicate devices:
- . Non-clinical system, software, and instrument verification and validation - demonstrated compliance with user needs and corresponding design inputs.
- . Surgical simulations conducted on cadavers were performed for system validation. The positional displacement is measured as the 3D (Euclidean) distance between the tips of the virtual and real implants, and the angular axis displacement is measured as the angle between the 3D trajectories of the virtual and real implants.
The overall 3D positional error measured in [mm] between the real and virtual pedicle screws for performance validation is summarized below:
Positional Error [mm]
ARAI System
Mean: 2.16
Standard deviation: 1.00
95% CI Upper Bound: 2.41
99% CI Upper Bound: 2.49
The overall 3D angular error measured in degrees between the real and virtual pedicle screws for performance validation is summarized below:
Angular Error [degrees]
ARAI System
Mean: 1.49
Standard deviation: 0.73
95% CI Upper Bound: 1.68
99% CI Upper Bound: 1.74
Additionally, bench top testing included tracking accuracy testing using phantoms and subsystem testing per ASTM F2554-18.
- Augmented Reality technical characteristics were demonstrated via performance testing . of display luminance, image contrast, latency and framerate, stereoscopic crosstalk and contrast, AR shutter frequency, and spatial accuracy (a measurement of disparity between the visualization of a real and virtual objects) under varying user conditions.
- Human factors and usability testing was conducted to evaluate the user interface and the ● system display in the intended user environment.
- Compliance conformity assessments per:
- IEC 60601-1 Medical electrical equipment. General requirements for basic 1. safety and essential performance
-
- IEC 60601-1-2 Medical electrical equipment. General requirements for basic safety and essential performance - Electromagnetic disturbances
- IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements 3. for Basic Safety and Essential Performance - Usability
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
StealthStation S8 Spine Software V1.0.0 (K170011)
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.
OpenSight (K172418), xvision Spine (K190929), Streamline Navigated Instruments (K200095), Streamline TL Spinal Fixation System (K192800), Streamline MIS Spinal Fixation System (K192396)
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
January 14, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Surgalign Spine Technologies Cristian Luciano Vice President of Research and Development 520 Lake Cook Road, Suite 315 Deerfield, Illinois 60015
Re: K211254
Trade/Device Name: ARAI Surgical Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: December 14, 2021 Received: December 15, 2021
Dear Cristian Luciano:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211254
Device Name ARAITM Surgical Navigation System
Indications for Use (Describe)
The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy.
The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------ | ----------------------------------------------- |
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3
K211254
510(k) Summary: ARAI™ Surgical Navigation System
| Company: | HOLO SURGICAL, INC.
(a subsidiary of Surgalign Spine Technologies) |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Cristian Luciano, PhD
Surgalign Spine Technologies
520 Lake Cook Road Suite 315
Deerfield, IL 60015
630-227-3809 |
| Date Prepared: | January 14, 2022 |
| Proprietary Name: | ARAI™ Surgical Navigation System |
| Common Name: | Stereotaxic Instrument |
| Classification: | 21 CFR 882.4560, 892.2050
Product Code(s): OLO, LLZ
Class II |
| Primary Predicate: | StealthStation S8 Spine Software V1.0.0 (K170011) |
| Reference Devices(s): | OpenSight (K172418)
xvision Spine (K190929)
Streamline Navigated Instruments (K200095)
Streamline TL Spinal Fixation System (K192800)
Streamline MIS Spinal Fixation System (K192396) |
Purpose:
The purpose of this submission is to request clearance of the HoloSurgical® ARAI™ Surgical Navigation System in either open or percutaneous orthopedic spine pedicle screw procedures.
Product Description:
The ARAI™ System is a combination of hardware and software that provides visualization of the patient's internal boney anatomy and surgical guidance to the surgeon based on registered patientspecific digital imaging.
ARAI™ is a navigation system for surgical planning and/or intraoperative guidance during stereotactic surgical procedures. The ARAI™ system consists of two mobile devices: 1) the surgeon workstation, which includes the display unit and the augmented reality visor (optional), and 2) the control workstation, which houses the optical navigation tracker and the computer. The optical navigation tracker utilizes infrared cameras and active infrared lights to triangulate the 3D location of passive markers attached to each system component to determine their 3D positions and orientations in real time. The 3D scanned data is displayed with both 2D images and 3D virtual models along with tracking information on computer mounted on workstations near the patient bed and a dedicated projection display mounted over the patient. Augmented reality is accomplished with the 3D virtual models being viewed with dedicated headset(s).
4
Software algorithms combine tracking information and high-resolution 3D anatomical models to display representations of patient anatomy.
Indications for Use:
The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy.
The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.
Technological Characteristics:
The ARAI™ System has the same design, materials, performance characteristics, and the same or equivalent labeling. The ARAI™ System is comparable to the predicate in terms of intended use, fundamental scientific technology, technological characteristics, and principle of operation.
5
Image /page/5/Picture/1 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter "H" on the left, followed by the word "HOLOSURGICAL" in blue, with a small "TM" symbol in brown to the right of the word. The letter "H" is made up of several geometric shapes, giving it a modern and technological look.
| Device | ARAI™ Surgical Navigation System | StealthStation S8 with Spine Software V1.0.0
(Predicate Device) | OpenSight
(Reference Device) | xvision Spine
(Reference Device) |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Subject Device | K170011 | K172418 | K190929 |
| Product code | OLO, LLZ | OLO | LLZ | OLO |
| Indications for Use | The ARAI™ System is intended as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy.
The ARAI System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be | 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 | 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 upon solely for absolute positional information and should always be |
| Device | ARAI™ Surgical Navigation
System | StealthStation S8 with Spine
Software V1.0.0
(Predicate Device) | OpenSight
(Reference Device) | xvision Spine
(Reference Device) |
| | displayed 2D stereotaxic
information. | | | |
| View
(Display
Features) | 2D axial, sagittal, and coronal 3D anatomical model Mesh Mode 3D, 2D anatomic orthogonal planes Trajectories Trajectory guidance Look Ahead Instrument's tip view Clipping tool Image Intensity 3D transparent User defined Implant AR OFF (3D OFF) | 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 (MIP) Video input | Normal Mode Volume Mode Alignment Mode Slice Mode | 2D images: axial and sagittal 3D anatomical model Trajectories Trajectory guidance Instrument's tip view 3D transparent 3D OFF (only 2D) 3D follow instrument movement |
| Software
operating
principle | The ARAI Software functionality
is described in terms of its feature
sets which are categorized as
imaging modalities, registration,
planning, interfaces with medical
devices, and views. Feature sets
include functionality that
contributes to clinical decision
making and are necessary to
achieve system performance. | StealthStation Spine Software
functionality is described in
terms of its feature sets which
are categorized as imaging
modalities, registration,
planning, interfaces with
medical devices, and views.
Feature sets include
functionality that contributes to
clinical decision making and
are necessary to achieve system
performance. | OpenSight uses the HoloLens
technology to register scanned
images over the patient when user
has OpenSight headset on and in
use. This allows the user to both
see the patient and through them,
with dynamic holograms of the
patient's internal anatomy.
OpenSight tools/features include
window level, segmentation and
rendering, registration, motion
correction, virtual tools, alignment,
and the capability to measure
distance and image intensity
values, such as standardized uptake
value. OpenSight displays
measurement lines, annotations,
and regions of interest. 3D images | Xvision Software receives the
intraoperative 3D scanner images
and calculates the registration
between the patient's anatomy and
the acquired intraoperative images.
then receives tracking information
and displays tracked virtual images
of the surgical instrument aligned
with the patient on the computer
monitor. The optical tracker is
embedded into the headset. |
| Device | ARAI™ Surgical Navigation
System | StealthStation S8 with Spine
Software V1.0.0
(Predicate Device) | OpenSight
(Reference Device) | xvision Spine
(Reference Device) |
| Patient and
surgical
instruments
tracking
method | Optical - infrared 6 DOF | Optical - infrared 6 DOF | Optical - infrared environment
scanning described as HoloLens
spatial mapping, process of
mapping real-world surfaces into
the virtual world.
include but not limited to tumors,
masses, appendices, heart, kidney,
bladder, stomach, blood vessels,
arteries, and nerves. | Optical - infrared 6 DOF |
| Registration
features | Automatic 3D Image Registration
performed after securely placing a
device with passive reflective
markers over the patient's anatomy
and scanning the surgical field
with an intraoperative scanner. | PointMerge Registration
SurfaceMerge Registration
FluoroMerge Registration
Automatic 2D Image
Registration
Automatic 3D Image
Registration | Registration does not require
infrared tracking devices or other
fiducials in order to perform
registration. Registration of the
patient (reality) to another image
data set such as MRI or CT
(augmented reality) are performed
by the OpenSight device which
contains infrared ranging cameras
which can map the surface
geometry of an object creating a
mesh of triangles conforming to
whatever the object is. This can
include the patient, the surrounding
room, the table, etc. The resolution
of the mesh is controlled by the
device. For mapping a large object
such as a room, a larger mesh
would be utilized. Surface
geometry mapping of a patient's
anatomy utilizes the maximum
resolution of the device while the
user may walk around the object in
a 360° circle mapping the object
from many views in order to obtain
the best localization in space. | Automatic 3D Image Registration
performed after placing a device
with passive reflective markers over
the patient's anatomy and scanning
the surgical field with an
intraoperative scanner. |
| Device | ARAI™ Surgical Navigation
System | StealthStation S8 with Spine
Software V1.0.0
(Predicate Device) | OpenSight
(Reference Device) | xvision Spine
(Reference Device) |
| Segmentation
and 3D model
generation | Voxels of medical datasets
(DICOM format) that correspond
to the spine are automatically
segmented and converted to a
polygonal mesh for displaying
purposes. | Voxels of medical datasets
(DICOM format) that
correspond to the spine are
automatically segmented and
converted to a polygonal mesh
for displaying purposes. | 3D anatomical structures are
segmented from diagnostic CT
scans are imported as a DICOM
file format to provide a direct
visualization of the patient's
anatomy. | Voxels of medical datasets (DICOM
format) that correspond to the spine
are automatically segmented and
converted to a polygonal mesh for
displaying purposes. |
| Medical
imaging
rendering | Polygonal mesh. | Both polygonal mesh and
volumetric rendering of the
spine are shown. | Both polygonal mesh, volumetric,
and slice rendering include but not
limited to tumors, masses,
appendices, heart, kidney, bladder,
stomach, blood vessels, arteries,
and nerves. | Both polygonal mesh and volumetric
rendering of the spine are shown. |
| Communication
between
Scanner and
platform/
computer | Encrypted USB for DICOM
import & export with Medtronic
O-arm | Network Connectivity, CD,
DVD, USAB, DICOM Import,
DICOM Export | WiFi communication with Novorad
server, not a scanner | USB & LAN connectivity using
DICOM |
Comparison of the Principles of Operation and Technological Characteristics
6
Image /page/6/Picture/0 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter H on the left, followed by the word "HOLOSURGICAL" in blue, sans-serif font. To the right of the word is the letters "TM" in a smaller font size.
7
Image /page/7/Picture/0 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter H on the left, followed by the word "HOLOSURGICAL" in blue. The letters are all capitalized, and there is a small "TM" symbol in the upper right corner of the word.
8
Image /page/8/Picture/1 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter H on the left, followed by the word "HOLOSURGICAL" in blue, sans-serif font. A small "TM" symbol is located to the right of the word.
9
Image /page/9/Picture/1 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter H on the left, followed by the word "HOLOSURGICAL" in blue. To the right of the word "HOLOSURGICAL" is the letters "TM" in a smaller font size.
Performance Testing:
Verification and validation testing was conducted on ARAI™ Surgical Navigation System to confirm that the device meets performance requirements under the indications for use and to ensure equivalent safety and efficacy of the system to the cited predicate devices:
- . Non-clinical system, software, and instrument verification and validation - demonstrated compliance with user needs and corresponding design inputs.
- . Surgical simulations conducted on cadavers were performed for system validation. The positional displacement is measured as the 3D (Euclidean) distance between the tips of the virtual and real implants, and the angular axis displacement is measured as the angle between the 3D trajectories of the virtual and real implants.
The overall 3D positional error measured in [mm] between the real and virtual pedicle screws for performance validation is summarized below:
| Performance
| Validation | Positional Error [mm] | |||
|---|---|---|---|---|
| Mean | Standard | |||
| deviation | 95% CI | |||
| Upper Bound | 99% CI | |||
| Upper Bound | ||||
| ARAI System | 2.16 | 1.00 | 2.41 | 2.49 |
The overall 3D angular error measured in degrees between the real and virtual pedicle screws for performance validation is summarized below:
| Performance
| Validation | Angular Error [degrees] | |||
|---|---|---|---|---|
| Mean | Standard | |||
| deviation | 95% CI | |||
| Upper Bound | 99% CI | |||
| Upper Bound | ||||
| ARAI System | 1.49 | 0.73 | 1.68 | 1.74 |
Additionally, bench top testing included tracking accuracy testing using phantoms and subsystem testing per ASTM F2554-18.
- Augmented Reality technical characteristics were demonstrated via performance testing . of display luminance, image contrast, latency and framerate, stereoscopic crosstalk and contrast, AR shutter frequency, and spatial accuracy (a measurement of disparity between the visualization of a real and virtual objects) under varying user conditions.
- Human factors and usability testing was conducted to evaluate the user interface and the ● system display in the intended user environment.
- Compliance conformity assessments per:
- IEC 60601-1 Medical electrical equipment. General requirements for basic 1. safety and essential performance
-
- IEC 60601-1-2 Medical electrical equipment. General requirements for basic safety and essential performance - Electromagnetic disturbances
- IEC 60601-1-6 Medical Electrical Equipment Part 1-6, General Requirements 3. for Basic Safety and Essential Performance - Usability
Biocompatibility:
The biocompatibility evaluation for ARAI™ Surgical Navigation System has been conducted in accordance with FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk
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Image /page/10/Picture/0 description: The image shows the logo for Holosurgical. The logo consists of a blue stylized letter H on the left, followed by the word "HOLOSURGICAL" in blue. The letters are a sans-serif font, and the letters are evenly spaced. To the right of the word is the trademark symbol.
management process'," June 16, 2016. The evaluation confirms that ARAI™ Surgical Navigation System meets biocompatibility requirements.
Electrical Safety and Electromagnetic Compatibility:
Testing was performed to assure compliance with recognized safety standard, IEC 60601-1:2012 standard for electrical safety and electromagnetic compatibility, IEC 60601-1-2:2014.
Software Verification and Validation Testing:
Software validation and verification testing was performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
A set of test samples presenting lumbosacral spine, extracted from stationary and intraoperative Computed Tomography scans was subjected to the autonomous spine segmentation process performed by the ARAI Spine Software. The quality of the autonomous anatomical segmentation applied by the ARAI Surgical Navigation System was determined by comparing it with manual segmentations prepared by trained analysts based on mean Sørensen-Dice coefficient (DSC) calculations.
Basis of Substantial Equivalence:
ARAI™ Surgical Navigation System has been found to be substantially equivalent to the predicate device with respect to technical characteristics, performance, and intended use. The reference predicate devices were relied upon to identify applicable test methods associated with AR technology. The information provided within this premarket notification supports the substantial equivalence to the cited predicate devices.