(233 days)
No
The summary describes image processing and navigation algorithms but does not mention AI, ML, or related terms.
No.
The device is an imaging system used to visualize anatomical structures, and an optional navigation system to localize anatomical structures and verify pilot hole placement. It does not directly treat a disease or condition.
No
The device is an imaging system and a navigation system used for visualization during orthopedic surgical procedures, not for diagnosing diseases or conditions.
No
The device description clearly states it is a "mobile fluoroscopic system" consisting of "two mobile C-arm and a monitor cart," which are hardware components. It also mentions an X-ray tube, image receptor flat panel detector, navigation tracking camera, and a GPU computer. While it contains software, it is not solely software.
Based on the provided text, the nView s1 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.
- nView s1 Function: The nView s1 is an imaging system that uses X-rays to visualize the internal anatomy of a patient in vivo (within the living body) during surgical procedures. It does not analyze samples taken from the body.
The device description clearly states its purpose is to provide "fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures" and to "image human anatomy." This aligns with the definition of an in vivo medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult and pediations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities.
The nView s1 is indicated to image human anatomy up to 30 cm thickness. The nView s1 is not indicated for mammographic or lung nodule applications.
The nView s1 with navigation option is intended as a navigation system to localize anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy.
Product codes
OWB, JAA, JAK, OXO, OLO
Device Description
The nView s1 with nav option mobile fluoroscopic system is a cone beam computed fluoroscopic and tomographic X-ray system consisting of two mobile C-arm and a monitor cart. The mobile C-arm is comprised of a fixed anode X-ray tube with a high voltage generator, X-ray controls, markers for image registration during navigation, and a mechanical "C" shaped structure which supports the X-ray chain, the image receptor flat panel detector, and navigation tracking camera is rigidly attached to the operating table and connects to the C-arm via a cable.
The monitor cart is a mobile platform containing a flat panel display and a GPU computer that connects to the mobile C-arm by ethernet cable.
Navigation instrumentation consists of a navigated surgical probe and a patient reference.
The device contains software. The nav option tracks single-use sterile navigation instrumentation. It does not contain biologics, drugs, coatings, or additives.
The device is intended to be used in a hospital facility immediately before, during, or after surgery.
The nView s1 with nav option employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D. The X-ray tube powered by a generator produces X-rays, which image the patient under control of the user, at the direction of a physician. The images from the system assist the physicians in visualizing the patient's anatomy during surgical procedures. The device poth real-time image capture and post capture visualization suitable for use immediately before, during, or after surgery. The optional navigation feature uses optical camera technology to display a surgeon's probe on the image in real time during the surgery. The device performs both 2D and 3D medical imaging generated by means of an iterative algorithm. The system uses of a scan captured with relation to a predefined scan reference frame to compute the three-dimensional representation of the imaged object. The images are displayed on the screen of the monitor cart. It is possible to display projection views as well as tomographic views. The navigation option utilizes optical camera technology to track the C-arm, the instruments, and the patient.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays, Fluoroscopic, Tomographic
Anatomical Site
high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities. Thoracic and lumbar spine for navigation.
Indicated Patient Age Range
Adult and pediatric populations over 6 years of age
Intended User / Care Setting
Hospital/ clinic
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 cadaveric specimen was used. It utilized a subset of system components and features that represent the worst-case combinations of all potential system components.
Summary of Performance Studies
The nView s1 with nav option has demonstrated 3D positional accuracy with a positional error
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
December 28, 2022
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
nView medical Lisa Last Chief Operating Officer 2681 E Parleys Way STE 107 SALT LAKE CITY, UT 84109
Re: K221344
Trade/Device Name: nView s1 with nav option Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, JAK, OXO, OLO Dated: November 28, 2022 Received: November 28, 2022
Dear Lisa Last:
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,
| Esther O. Akinnagbe- | Digitally signed by Esther O. |
|---|---|
| zusterzeel -S | Akinnagbe-zusterzeel -S |
| Date: 2022.12.28 13:14:15 -05'00' |
For Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K221344
Device Name nView s1 with nav option
Indications for Use (Describe)
The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult and pediations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities.
The nView s1 is indicated to image human anatomy up to 30 cm thickness. The nView s1 is not indicated for mammographic or lung nodule applications.
The nView s1 with navigation option is intended as a navigation system to localize anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy.
| 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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Page 001 53
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510(k) Summary for K221344
The following statement is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter Information
- Submitter: nView medical, Inc. 2681 E. Parleys Way, Suite 107 Salt Lake City, Utah 84109
Contact: Ms. Lisa Last Chief Operating Officer/ Regulatory Affairs lisa.last@nviewmed.com T 617.283.7053
Preparation Date: November 28, 2022
Subject Device Information
| Device Name: | nView s1 with nav option |
|---|---|
| Common/Usual Name: | Mobile Fluoroscopic C-Arm |
| Primary Regulation Number: | CFR 892.1650 |
| Primary Regulation Name: | Image-intensified fluoroscopic x-ray system |
| Primary Regulatory Class: | II |
| Primary Product Code: | OWB |
| Secondary Product Codes: | OXO, JAA, JAK, OLO |
Predicate Device Information
| Device Name (510(k) number): | nView s1 with nav option (K211064) |
|---|---|
| Common/Usual Name: | Mobile Fluoroscopic C-Arm |
| Regulation Number: | CFR 892.1650 |
| Regulation Name: | Image-intensified fluoroscopic x-ray system |
| Regulatory Class: | II |
| Primary Product Code: | OWB |
| Secondary Product Codes: | OXO, JAA, JAK, OLO |
Reference Device Information
| Device Name (510(k) number): | Medtronic Navigation Inc - StealthStation™ S8 system (K162309) |
|---|---|
| Common/Usual Name: | Neurological Stereotaxic Instrument |
| Regulation Number: | CFR 882.4560 |
| Regulation Name: | Stereotaxic Instrument |
| Regulatory Class: | II |
| Product Codes: | HAW, OLO, PGW |
4
Device Description:
Device Identification: The nView s1 with nav option mobile fluoroscopic system is a cone beam computed fluoroscopic and tomographic X-ray system consisting of two mobile C-arm and a monitor cart. The mobile C-arm is comprised of a fixed anode X-ray tube with a high voltage generator, X-ray controls, markers for image registration during navigation, and a mechanical "C" shaped structure which supports the X-ray chain, the image receptor flat panel detector, and navigation tracking camera is rigidly attached to the operating table and connects to the C-arm via a cable.
The monitor cart is a mobile platform containing a flat panel display and a GPU computer that connects to the mobile C-arm by ethernet cable.
Navigation instrumentation consists of a navigated surgical probe and a patient reference.
Device Characteristics: The device contains software. The nav option tracks single-use sterile navigation instrumentation. It does not contain biologics, drugs, coatings, or additives.
Environment of Use: The device is intended to be used in a hospital facility immediately before, during, or after surgery.
Brief Written Description of the Device: The nView s1 with nav option employs X-rays as its imaging technology for visualizing human anatomy in both 2D and 3D. The X-ray tube powered by a generator produces X-rays, which image the patient under control of the user, at the direction of a physician. The images from the system assist the physicians in visualizing the patient's anatomy during surgical procedures. The device poth real-time image capture and post capture visualization suitable for use immediately before, during, or after surgery. The optional navigation feature uses optical camera technology to display a surgeon's probe on the image in real time during the surgery.
Key Performance Specifications/Characteristics of the device performs both 2D and 3D medical imaging generated by means of an iterative algorithm. The system uses of a scan captured with relation to a predefined scan reference frame to compute the three-dimensional representation of the imaged object. The images are displayed on the screen of the monitor cart. It is possible to display projection views as well as tomographic views. The navigation option utilizes optical camera technology to track the C-arm, the instruments, and the patient.
Changes to predicate: The changes to the currently cleared nView s1 with nav option are as follows:
- . a phrase change in the indications for use to modify the ordering of the navigation tasks indicated for the device
- . an additional navigation registration mode where the patient reference is attached to the the image and then a paired point registration is performed to register the imaging and navigation coordinate frames
Indications for Use:
The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic and tomographic imaging of patients during orthopedic surgical procedures where the clinician benefits from 3D visualization of complex anatomical structures, such as high contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint fractures of the upper and lower extremities.
The nView s1 is indicated to image human anatomy up to 30 cm thickness.
5
The nView s1 is not indicated for mammographic or lung nodule applications.
The nView s1 with navigation option is intended as a navigation system to localize anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine regions. The navigation option is indicated for posterior approach open spinal procedures in pediatic populations over 6 years of age in which the use of stereotactic surgery may be appropriate, and where reference to a rigid spinous process can be identified relative to nView s1 images of the anatomy.
Comparison of Technology with Predicate
Intended Use
| SUBJECT
DEVICE
nView s1 with nav
option | The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult
and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic
and tomographic imaging of patients during orthopedic surgical procedures where the
clinician benefits from 3D visualization of complex anatomical structures, such as high
contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint
fractures of the upper and lower extremities.
The nView s1 is indicated to image human anatomy up to 30 cm thickness.
The nView s1 is not indicated for mammographic or lung nodule applications.
The nView s1 with navigation option is intended as a navigation system to localize
anatomical structures in spine fusion procedures for tasks such as identifying vertebrae, and
identifying entry points in the thoracic and lumbar spine regions; and for the task of pilot hole
verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine
regions. The navigation option is indicated for posterior approach open spinal procedures in
pediatric populations over 6 years of age in which the use of stereotactic surgery may be
appropriate, and where reference to a rigid spinous process can be identified relative to
nView s1 images of the anatomy. |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PREDICATE
DEVICE
nView s1 with nav
option (K211064) | The nView s1 is intended as an imaging system to provide both 2D and 3D imaging of adult
and pediatric populations over 6 years of age. The device is intended to provide fluoroscopic
and tomographic imaging of patients during orthopedic surgical procedures where the
clinician benefits from 3D visualization of complex anatomical structures, such as high
contrast objects, bones, joints, cervical, thoracic, and lumbar regions of the spine, and joint
fractures of the upper and lower extremities.
The nView s1 is indicated to image human anatomy up to 30 cm thickness.
The nView s1 is not indicated for mammographic or lung nodule applications.
The nView s1 with navigation option is intended as a navigation system to aid in pilot hole
verification for pedicle screw placement of 4.5 mm screws in the thoracic and lumbar spine
regions. The navigation option is indicated for posterior approach open spinal procedures in
pediatric populations over 6 years of age in which the use of stereotactic surgery may be
appropriate, and where reference to a rigid spinous process can be identified relative to
nView s1 images of the anatomy. |
EQUIVALENT- nView's subject device has essentially the same indications as the predicate. Both devices are indicated for tasks in spine fusion procedures. The phrasing has been updated for formatting only. Both devices have the same patient population, the same reference to a rigid spinous process, and the same use of the nView s1 image.
6
Technological Characteristics
| ATTRIBUTE | SUBJECT DEVICE
nView s1 with nav option | PREDICATE DEVICE
nView s1 with nav option
(K211064) | REFERENCE DEVICE
Medtronic StealthStation
(K162309) | SUBSTANTIAL
EQUIVALENCE |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| target population | adult and pediatric
populations over 6 years of
age with imaged anatomy up
to 30 cm thickness (pediatric
only for the navigation
option) | adult and pediatric
populations over 6 years
of age with imaged
anatomy up to 30 cm
thickness (pediatric only
for the navigation option) | all adult and pediatric
populations | IDENTICAL to
predicate |
| anatomical site | high contrast bony anatomy
for imaging, thoracic and
lumbar spine for navigation | high contrast bony
anatomy for imaging,
thoracic and lumbar
spine for navigation | | IDENTICAL |
| where used | Hospital/ clinic | Hospital/ clinic | Hospital/ clinic | IDENTICAL |
| Input Power
(VAC) | 120 | 120 | 120 | IDENTICAL |
| Mobile Platform | Yes | Yes | Yes | IDENTICAL |
| Imaging Platform | | | | |
| C-arm Gantry | Yes | Yes | N/A | IDENTICAL |
| # of Axes | 6 axes of motion, 1
motorized, one tracked with
encoders | 6 axes of motion, 1
motorized, one tracked
with encoders | N/A | IDENTICAL |
| User Interface | Touch control | Touch control | N/A | IDENTICAL |
| Fluoroscopic | Yes - via real-time digital
projections | Yes - via real-time digital
projections | N/A | IDENTICAL |
| Tomographic | Yes | Yes | N/A | IDENTICAL |
| Tube Type | Stationary Reflective Anode | Stationary Reflective
Anode | N/A | IDENTICAL |
| Tube Focal Spot
Size | 0.6mm | 0.6 mm | N/A | IDENTICAL |
| X-Ray Tube Max
kV/ mA/ W | 75/12/350 | 75/12/350 | N/A | IDENTICAL |
| Detector Type | CMOS Digital Detector | CMOS Digital Detector | N/A | IDENTICAL |
| Detector Shape | Square | Square | N/A | IDENTICAL |
| Detector Size
(cm) | 30 cm x 30 cm | 30 cm x 30 cm | N/A | IDENTICAL |
| Detector
Resolution | 1952 x 1952 | 1952 x 1952 | N/A | IDENTICAL |
| Distortion Free
Imaging | Yes | Yes | N/A | IDENTICAL |
| Collimator/Beam
Limiter | Yes | Yes | N/A | IDENTICAL |
| Anatomy
Alignment | Physical Markers | Physical Markers | N/A | IDENTICAL |
| Reconstruction
Geometry | Multi Arc Source Trajectory | Multi Arc Source
Trajectory | N/A | IDENTICAL |
| Dataset
Capabilities | 2D and 3D | 2D and 3D | N/A | IDENTICAL |
| ATTRIBUTE | SUBJECT DEVICE
nView s1 with nav option | PREDICATE DEVICE
nView s1 with nav option
(K211064) | REFERENCE DEVICE
Medtronic StealthStation
(K162309) | SUBSTANTIAL
EQUIVALENCE |
| Acquisition time
(s) | 2, 4, 8 | 2, 4, 8 | N/A | IDENTICAL |
| Reconstruction
Time (s) | 1 to 30 | 1 to 30 | N/A | IDENTICAL |
| 3D resolution
(mm) | 0.721 x 0.721 x 0.721 | 0.721 x 0.721 x 0.721 | N/A | IDENTICAL |
| 3D
Reconstruction
Type (deg) | Maximum of 117 multi arc | Maximum of 117 multi
arc | N/A | IDENTICAL |
| 3D reconstruction
algorithm | Iterative reconstruction with
positivity, denoising
regularizers | Iterative reconstruction
with positivity,
denoising regularizers | N/A | IDENTICAL |
| Navigation Characteristics | | | | |
| Imaging
Modality | nView s1 images | nView s1 images | CT, MRI, or fluoro images | EQUIVALENT, the
subject and predicate
work on the same
nView s1 images, the
reference device
uses generic
third-party images. |
| Patient
Registration
Options | Automatic image
registration with patient
reference placed before
imaging, paired point
registration with patient
reference placed after
imaging | Automatic image
registration with patient
reference placed before
imaging | PointMerge® registration,
Tracer™
registration, Touch
registration,
StealthAiR® registration,
O-arm® registration,
Mechanical based
registrations | EQUIVALENT, the
subject device
supports the identical
Automatic
registration mode as
the predicate, and a
paired point
registration mode
that is equivalent to
the PointMerge
registration in the
reference device. |
| Tracking
Technology | Optical infrared Camera | Optical infrared
Camera | Optical infrared Camera | IDENTICAL |
| Instrument
Tracking Method | passive marker sensor
system | passive marker sensor
system | passive marker sensor
system | IDENTICAL |
| Patient Tracking
Method | Via patient reference | Via patient reference | Via patient reference | IDENTICAL |
| Registration
Accuracy | 3D positional accuracy with
a positional error