(128 days)
No
The summary describes a system using infrared tracking and image registration for augmented reality guidance, but there is no mention of AI or ML being used for image processing, analysis, or any other function. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
This device is intended as an aid for precisely locating anatomical structures and does not directly treat or cure any medical condition.
No
This device is intended as an aid for precisely locating anatomic structures during surgical procedures, specifically for guidance and navigation, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a tracking camera, workstation, cart, headsets, and tracked instruments, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- OnPoint System Function: The OnPoint Augmented Reality Spine System is a surgical navigation system. It uses imaging data and tracking technology to help surgeons precisely locate anatomical structures during spine procedures. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's an "aid for precisely locating anatomic structures in either open or percutaneous spine procedures." This is a surgical guidance function, not an in vitro diagnostic function.
- Device Description: The description details components like tracking cameras, headsets, and software used for surgical navigation, not for analyzing biological samples.
Therefore, the OnPoint Augmented Reality Spine System falls under the category of surgical navigation or guidance systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System Software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures, such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the CT images of the anatomy.
The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the virtual screen is indicated for displaying the virtual in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location from plan.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The OnPoint Augmented Reality Spine System is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. Infrared tracking technology is used to track the patient's anatomy as well as surgical instrumentation. The tracking information is registered with image information of the patient's anatomy in a common coordinate system. To guide the surgeon through the pedicle screw placement process, the system will display a visual representation of the following elements in an augmented reality optical head mounted display in addition to being displayed on a workstation monitor:
- . Target position and orientation of toolpat
- . Current position and orientation of instrument
- . Cross sectional images
- . 3D model of the patient's spine
Depending on surgeon preference, different combinations of these elements can be displayed. Optional planning steps allow the surqeon to define the target position and orientation as well as length and diameter of the pedicle screws.
The OnPoint Augmented Reality Spine System consists of the following components:
- Tracking camera, workstation, and cart ●
- . Headsets with supplemental battery
- . Software
- Tracked instruments and adapters ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray Based Imaging
Anatomical Site
spine or pelvis, thoracic and sacro-lumbar region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgeons or neurosurgeons, Operating Room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The system's accuracy was validated in a cadaver study, in which pedicle screws were positioned in the thoracic and sacro-lumbar vertebrae. The positional and trajectory errors were calculated as the difference between the actual and virtual screw tip position, and the difference between the screw orientation and its recorded virtual trajectory. Clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing the post-op scans. Additionally, tracking accuracy was verified per ASTM F2554-22 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.
Registration Testing. The auto-registration accuracy was tested using multiple 3D CT scanners. Supported scanners were determined to provide at least the same level of accuracy as a manual registration using a standard 2D CT scan.
OnPoint AR Image Quality Testing. The augmented reality glasses display performance was verified for the intended use. Performance specifications assessed included primary visual characteristics (luminance, color, transmission, field of view, and eye-box), virtual image resolution, interocular photometric differences, and vergence-accommodation measurements.
Human Factors Usability Testing was conducted in accordance with internal SOPs and FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (issued February 2016) and IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices. Human Factors Usability Testing was conducted with intended users in a simulated use environment to ensure the user needs and intended use requirements were met.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Cadaver study for system accuracy on pedicle screws in thoracic and sacro-lumbar vertebrae. Positional and trajectory errors were calculated. Clinical accuracy was evaluated using the Gertzbein-Robbins score. Tracking accuracy was verified per ASTM F2554-22.
Auto-registration accuracy was tested using multiple 3D CT scanners.
Augmented reality glasses display performance was verified for luminance, color, transmission, field of view, eye-box, virtual image resolution, interocular photometric differences, and vergence-accommodation measurements.
Human Factors Usability Testing with intended users in a simulated use environment to ensure user needs and requirements were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System Level Accuracy with a mean 3D positional error of 2.0mm and mean trajectory error of 2°
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.
Xvision Spine System, manufactured by Augmedics, Ltd. (K220905)
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.
S8 Stealthstation, manufactured by Medtronic Navigation, Inc. (K201189)
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
September 8, 2023
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 and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of an eagle and a caduceus, while the FDA acronym and name are written in blue, with the word "Administration" appearing below the acronym and name.
OnPoint Surgical, Inc. Amy Odonnell Sr. Director Quality and Regulatory Affairs 19 Crosby Drive, Suite 120 Bedford, Massachusetts 01730
Re: K231284
Trade/Device Name: OnPoint Augmented Reality Spine System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: May 2, 2023 Received: May 3, 2023
Dear Amy Odonnell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231284
Device Name OnPoint Augmented Reality Spine System
Indications for Use (Describe)
The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System Software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures, such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the CT images of the anatomy.
The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the virtual screen is indicated for displaying the virtual in relation to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location from plan.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image is a logo for OnPoint Surgical. The logo features a circular icon on the left, composed of concentric circles in blue and teal, with a line extending from the center. To the right of the icon, the word "onPoint" is written in a clean, sans-serif font, with the word "SURGICAL" in smaller letters underneath, separated by a thin line.
510(k) Summary
OnPoint Augmented Reality Spine System
| Submitter | OnPoint Surgical, Inc. |
|---|---|
| Address | 19 Crosby Drive, Suite 120 |
| Bedford, MA 01730 | |
| Phone: | (781) 218-9742 |
| Contact Person | Amy O'Donnell |
| Date Prepared | May 2, 2023 |
Device Information:
| Device Name | OnPoint Augmented Reality Spine System |
|---|---|
| Common Name | Spine Navigation System |
| Classification Name | |
| & Regulation | Orthopedic Stereotaxic Instrument |
| 21 CFR 882.4560 | |
| Regulatory Class | Class II |
| Product Code | OLO |
| Predicate Device | Xvision Spine System, manufactured by Augmedics, Ltd. |
| (K220905) | |
| Reference Device | S8 Stealthstation, manufactured by Medtronic Navigation, |
| Inc. (K201189) |
Intended Use / Indications for Use
The OnPoint Augmented Reality Spine System, with OnPoint Augmented Reality Spine System software, is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. The use of the OnPoint Augmented Reality Spine System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a bony anatomical structure, such as the spine or pelvis, can be identified relative to CT images of the anatomy. This can include spinal implant procedures, such as pedicle screw placement, where the surgeon wants to see a tracked instrument location in relationship to the stereotaxic display of the CT images of the anatomy.
4
Image /page/4/Picture/1 description: The image is a logo for OnPoint Surgical. The logo features a circular design on the left, with three concentric circles in blue and teal. A line extends from the center of the circles to the outer edge. To the right of the circle is the text "onPoint" in blue, with the word "SURGICAL" in smaller letters below it. A horizontal line separates the two words.
The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical tarqeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient images. The virtual screen is indicated for displaying the virtual instrument location to the virtual anatomy to assist in percutaneous visualization and trajectory planning. The graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location including deviation from plan.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information.
Device Description
The OnPoint Augmented Reality Spine System is intended as an aid for precisely locating anatomic structures in either open or percutaneous spine procedures. Infrared tracking technology is used to track the patient's anatomy as well as surgical instrumentation. The tracking information is registered with image information of the patient's anatomy in a common coordinate system. To guide the surgeon through the pedicle screw placement process, the system will display a visual representation of the following elements in an augmented reality optical head mounted display in addition to being displayed on a workstation monitor:
- . Target position and orientation of toolpath
- . Current position and orientation of instrument
- . Cross sectional images
- . 3D model of the patient's spine
Depending on surgeon preference, different combinations of these elements can be displayed. Optional planning steps allow the surqeon to define the target position and orientation as well as length and diameter of the pedicle screws.
The OnPoint Augmented Reality Spine System consists of the following components:
- Tracking camera, workstation, and cart ●
- . Headsets with supplemental battery
- . Software
- Tracked instruments and adapters ●
5
Image /page/5/Picture/1 description: The image shows the logo for OnPoint Surgical. The logo features a circular design with concentric rings in blue and teal, with a line extending from the center to the outer ring. To the right of the circular design, the words "onPoint" are written in blue, with the word "SURGICAL" written in smaller letters below a horizontal line.
Summary of Technological Characteristics
The OnPoint Augmented Reality Spine System is similar in its technological features to its predicate device, the Augmedics Xvision Spine Systems include similar hardware and software components, with the following basic components: software, optical head mounted display (OHMD), tracking camera, rigid spinal or pelvic reference point, and reusable instrument adaptors.
The OHMD in both systems is positioned on the surgeon's head and is designed to provide 2D and 3D augmented reality (AR) display with overlaid navigation information to aid in pedicle screw placement. The software in both systems is designed for real time calculation and display of the spatial position of the surgical instruments relative to patient's anatomy. Both systems share the same safety features and are compatible with similar intraoperative scanners. Both systems follow similar fundamental principles of operation.
| Characteristic | OnPoint Augmented Reality Spine
System
(this submission) | Predicate Device
Augmedics Xvision Spine System
(K220905) | Conclusion |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The OnPoint Augmented Reality
Spine System, with OnPoint
Augmented Reality Spine System
software, is intended as an aid for
precisely locating anatomic
structures in either open or
percutaneous spine procedures.
The use of the OnPoint Augmented
Reality Spine System is indicated for
any medical condition in which the | 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 | Same intended use. The
predicate has slightly
different wording. |
| | use of stereotactic surgery may be | as the spine or pelvis, can be | |
| | appropriate, and where reference to | identified relative to CT imagery of
the anatomy. | |
| | a bony anatomical structure, such | The Headset of the Xvision Spine | |
| | as the spine or pelvis, can be | System displays 2D stereotaxic | |
| | identified relative to CT images of | screens and a virtual anatomy | |
| | the anatomy. This can include spinal | screen. The stereotaxic screen is | |
| | implant procedures, such as pedicle | indicated for correlating the tracked | |
| | screw placement, where the | instrument location to the registered | |
| | surgeon wants to see a tracked
instrument location in relationship to
the stereotaxic display of the CT
images of the anatomy. | patient imagery. The virtual screen
is indicated for displaying the virtual
instrument location in relation to the | |
| Characteristic | OnPoint Augmented Reality Spine System
(this submission) | Predicate Device
Augmedics Xvision Spine System
(K220905) | Conclusion |
| | The optical head mounted display of the OnPoint Augmented Reality Spine System displays 2D stereotaxic screens and an optional virtual anatomy screen, paired with optional graphical targeting tools and alphanumeric displays. The stereotaxic screen is indicated for correlating the tracked instrument location to the registered patient images. 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 graphical targeting tools and alphanumeric display are indicated for providing visual and quantitative tracking information of the tracked instrument location including deviation from plan.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information. | virtual anatomy to assist in percutaneous visualization and trajectory planning.
The virtual display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed stereotaxic information. | |
| Spinal implant
procedures | Posterior pedicle screw placement in the thoracic and sacro-lumbar region. | Spinal implant procedures:
● Posterior Pedicle Screw Placement in the thoracic and sacro-lumbar region
● Posterior Screw Placement in C3-C7 vertebrae
● Iliosacral Screw | Similar. Even though the predicate is cleared for a broader range of spinal implant procedures, OnPoint is requesting clearance for posterior pedicle screw placement in the thoracic and sacro-lumbar region. |
| Intended User
Population | Orthopedic surgeons or neurosurgeons | Orthopedic surgeons or neurosurgeons | Same |
| Intended Use
Environment | Operating Room | Operating Room | Same |
| System
Components | ● Headset with near eye see-through display
● Software application
● Instrument adaptors | ● Headset with near eye see-through display and tracking camera
● Software application
● Flat reflective markers | Similar. There are minor differences with the instrumentation and the workstation, but the |
| Characteristic | OnPoint Augmented Reality Spine | Predicate Device | Conclusion |
| | System | Augmedics Xvision Spine System | |
| | (this submission) | (K220905) | |
| | Rigid Spinal Reference point:
• Spinal Clamp and Iliac Crest
Pin
• Workstation cart with computer,
tracking camera, router,
monitors, keyboard, and
universal power supply | • Instrument adaptors
• Reference point: Patient
clamp and perc pin
• Accessories: Panel PC, roll
stand, 8" tablet (Remote UI) | principles of operation
are still the same. |
| Modes of
Operation | • Patient preparation
• System set-up
• Intraoperative scan
• Scan import
• Patient registration
• Surgical planning
• Navigation | • Patient preparation
• System set-up
• Intraoperative scan
• Scan import
• Patient registration
• Navigation | Similar. There are minor
differences between themodes of operations, but
the general workflow
follows standard surgical
technique. |
| Localization
Technology | Optical | Optical | Same |
| Optical Tracker | Infrared cameras, positioned 2-3
meters from the surgical site | Single infrared camera, positioned
0.5m above tracked objects | Similar. The position of
the tracking camera is
different due the tracking
camera location. |
| Tracking | 6 DOF | 6 DOF | Same |
| System
Accuracy
Requirement | System Level Accuracy with a mean
3D positional error of 2.0mm and
mean trajectory error of 2° | System Level Accuracy with a mean
3D positional error of 2.0mm and
mean trajectory error of 2° | Same |
| Imaging
Modality | X-Ray Based Imaging | X-Ray Based Imaging | Same |
| Medical Device
Interfaces | • O-arm Imaging System by
Medtronic
• Airo TruCT system by Stryker
• Globus Excelsius 3D | • O-arm Imaging System by
Medtronic
• Ziehm Vision FD Vario 3D C-
Arm and RFD 3D
• Siemens CIOS Spin
• Airo TruCT system by Stryker
• GE OEC 3D scanner | Similar. Even though the
predicate is cleared for a
broader range of device
interfaces, OnPoint
Surgical is going to
support the O-Arm, the
Airo, and the
Excelsius3D. |
| Display
Features | • 2D images: axial and sagittal
• 3D model
• Trajectories
• Trajectory guidance
• Instrument's tip view
• 3D transparent
• 3D OFF (only 2D)
• 3D follow instrument movement | • 2D images: axial and sagittal
• 3D model
• Trajectories
• Trajectory guidance
• Instrument's tip view
• 3D transparent
• 3D OFF (only 2D)
• 3D follow instrument
movement | Same. |
| Communication
between
Scanner | USB & LAN connectivity using
DICOM | USB & LAN connectivity using
DICOM | Same. |
| Characteristic | OnPoint Augmented Reality Spine
System
(this submission) | Predicate Device
Augmedics Xvision Spine System
(K220905) | Conclusion |
| and Platform/
Computer
Display and
Optics
Technology | Augmented Reality using near
eye see-through display Workstation monitors | Augmented Reality using near
eye see-through display Workstation monitor | Same. |
| Communication
between OHMD
and Computer | Wireless, encrypted | Wireless, encrypted | Same. |
| Supported
Frequencies &
Transmission
Protocol | 2.4GHZ & 5 GHz
802.11g/n/ac | 2.4GHZ & 5 GHz
802.11g/n/ac | Same |
| Frame Rate of
Displayed
Images | 60 fps | 60 fps | Same |
| OHMD Field of
View | ~52 degree FoV, 42 pixels per
degree (PPD) | 32.50 (vertical) X 180 (horizontal) | Similar. The OnPoint
OHMD has a larger FoV
which should result in
less peripheral vision
risk. |
| OHMD
Resolution | 3840 by 1080 pixels (1920x1080 per
eye) | 1280x720 per eye | Similar. The OnPoint
OHMD has more pixels
which should result in a
clearer display. |
| OHMD Power
Source | Li-ion rechargeable battery | Li-ion rechargeable battery | Same. |
| Number of
Supported
OHMDs | Three | Two | Similar. The OnPoint
Augmented Reality Spine
System can support up
to 3 headsets at one
time. |
| Rigid Reference
Point | Spinal clamp with spinal array
is attached to the spinous
process Iliac crest pin is inserted into
posterior superior iliac spine
(PSIS) with adapter for spinal
array | Patient clamp attached to the
spinous process Perc pin inserted into the PSIS | Similar. The rigid
reference points are the
same with respect to
where they touch the
patient and their intended
function. There may be
differences with how the
tracking arrays are
attached. |
| Instrument
(Tool)
Adaptors | Reusable Universal and power instrument
adapters (connects to various
rotating 3rd party instruments) System specific adapters to | Reusable Universal (connects to various
instruments) - not system
specific VP & Ergonomic (system
specific adaptors) | Similar. The instrument
adapters allow tracking
arrays to be connected to
3rd party devices. There
may be minor differences
in the connection |
| Characteristic | OnPoint Augmented Reality Spine
System
(this submission) | Predicate Device
Augmedics Xvision Spine System
(K220905) | Conclusion |
| | connect to the 3rd party
instrument
• Fixed adapters that connect to
instruments that do not rotate | | mechanisms and/or
instrument dimensions. |
A table comparing the key features of the subject and the predicate devices is provided below:
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Image /page/6/Picture/1 description: The image is a logo for OnPoint Surgical. The logo features a circular icon on the left, with three concentric circles in blue and teal. A line extends from the center of the circles to the outer edge. To the right of the icon is the text "onPoint" in blue, with the word "SURGICAL" in smaller letters below a horizontal line.
7
Image /page/7/Picture/1 description: The image is a logo for OnPoint Surgical. The logo features a blue and teal circular design with a line extending from the center. To the right of the circular design, the words "onPoint" are written in blue, with the word "SURGICAL" written in smaller letters below it.
8
Image /page/8/Picture/1 description: The image shows the logo for OnPoint Surgical. The logo features a circular design with concentric rings in blue and teal, resembling a radar or target symbol. To the right of the circle is the text "onPoint" in a clean, sans-serif font, with the word "SURGICAL" in smaller, all-caps letters underneath and slightly offset to the right.
9
Image /page/9/Picture/1 description: The image is a logo for OnPoint Surgical. The logo features a circular icon on the left, composed of three concentric circles in blue and teal, with a line extending from the center to the outer edge. To the right of the icon, the words "onPoint" are written in a blue sans-serif font, with the word "SURGICAL" in smaller letters underneath.
Performance Data
The following testing was conducted to evaluate the device:
- The system's accuracy was validated in a cadaver study, in which pedicle screws ● were positioned in the thoracic and sacro-lumbar vertebrae. The positional and trajectory errors were calculated as the difference between the actual and virtual screw tip position, and the difference between the screw orientation and its recorded virtual trajectory. Clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing the post-op scans. Additionally, tracking accuracy was verified per ASTM F2554-22 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems.
- Registration Testing The auto-registration accuracy was tested using multiple 3D . CT scanners. Supported scanners were determined to provide at least the same level of accuracy as a manual registration using a standard 2D CT scan.
- OnPoint AR Image Quality Testing The augmented reality glasses display . performance was verified for the intended use. Performance specifications assessed included primary visual characteristics (luminance, color, transmission, field of view, and eye-box), virtual image resolution, interocular photometric differences, and vergence-accommodation measurements.
- Human Factors Usability Testing was conducted in accordance with internal SOPs . and FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (issued February 2016) and IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices. Human Factors Usability Testing was conducted with intended users in a simulated use environment to ensure the user needs and intended use requirements were met.
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Image /page/10/Picture/1 description: The image is a logo for OnPoint Surgical. The logo features a circular design with three concentric circles in blue and teal, with a line extending from the center to the outer circle. To the right of the circular design is the text "onPoint" in a blue sans-serif font, with the word "SURGICAL" in a smaller font below a horizontal line.
- Electrical safety The system was tested in accordance with IEC 60601-1 Edition 3.2 2020-08 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- Electromagnetic Compatibility (EMC) The system was tested in accordance with . IEC 60601-1-2 Edition 4.1 2020-09 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- Biocompatibility The biocompatibility of all tissue contacting materials was . assessed according to ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (issued September 2020).
- Software verification and validation testing The software design and development . life cycle processes are aligned with IEC 62304:2006/A1:2016 Medical device software - Software life cycle processes. Software testing was conducted in accordance with internal SOPs that are based on the FDA Guidance General Principles of Software Validation (issued January 2002).
Verification/validation testing of the OnPoint Augmented Reality Spine System has been successfully completed and demonstrates that the device is safe for its intended use and is substantially equivalent to the predicate device.
Conclusions
The OnPoint Augmented Reality Spine System is substantially equivalent to its predicate, the cleared Augmedics Xvision Spine System. The OnPoint Augmented Reality Spine System has the same intended use, technological characteristics, and principles of operation as the predicate. None of the minor differences in technology raise new types of safety or effectiveness questions. Performance data demonstrated that the OnPoint Augmented Reality Spine System functions as intended.