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.

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 ●

AI/ML Overview

The provided text, a 510(k) summary for the OnPoint Augmented Reality Spine System, describes various performance tests conducted to demonstrate the device's substantial equivalence to a predicate device. However, it does not provide specific acceptance criteria or detailed results for all mentioned tests in a comparative format.

The document primarily focuses on explaining the types of tests performed rather than presenting the quantitative acceptance criteria and the actual performance data against those criteria. It states that "Verification/validation testing... has been successfully completed and demonstrates that the device is safe for its intended use and is substantially equivalent to the predicate device," but does not explicitly list the numerical results that support this claim for each criterion.

Based on the provided text, I can infer and extract some information related to your request, but many details, particularly the quantitative performance data against specific acceptance criteria, are not present.

Here's a breakdown of what can be extracted and what is missing, structured according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, only one specific numerical acceptance criterion is explicitly stated for the "System Accuracy Requirement":

Acceptance Criterion (System Level Accuracy)	Reported Device Performance
Mean 3D positional error of 2.0mm	Not explicitly reported
Mean trajectory error of 2°	Not explicitly reported

Note: The document states that the system's accuracy was validated in a cadaver study, and that "positional and trajectory errors were calculated," but it does not then report the calculated values against these 2.0mm and 2° criteria. It only states that the device "functions as intended" and "demonstrates that the device is safe for its intended use and is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Cadaver Study (Accuracy Validation): The document mentions "a cadaver study" (singular) for accuracy validation. It does not specify the number of cadavers used, the number of screw placements, or the number of anatomical regions targeted.
Registration Testing: "multiple 3D CT scanners" were used, but the number of scanners or the number of tests performed is not specified.
OnPoint AR Image Quality Testing: No sample size is mentioned.
Human Factors Usability Testing: No specific sample size (number of users or use cases) is mentioned, other than "intended users."
Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given it is a 510(k) submission to the FDA, the studies would typically be conducted to support a premarket notification for a U.S. device. Cadaver studies are inherently prospective for the data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document states that "Clinical accuracy was evaluated using the Gertzbein-Robbins score by viewing the post-op scans." This implies expert review. However, it does not specify the number of experts involved in this evaluation or their qualifications (e.g., "Radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document mentions "viewing the post-op scans" for clinical accuracy (Gertzbein-Robbins score). This suggests a review process, but it does not specify any adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies among expert reviews, if multiple experts were used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not describe an MRMC comparative effectiveness study in the context of human readers improving with AI assistance. The device is a "Spine Navigation System" with "Augmented Reality," intended to aid in precisely locating anatomical structures during surgery. It is not an AI diagnostic algorithm for image reading. The clinical accuracy assessment focusing on the Gertzbein-Robbins score post-op is an objective measure of screw placement, not a comparative reading study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The "System Level Accuracy" (mean 3D positional error and mean trajectory error) and "tracking accuracy verified per ASTM F2554-22" tests are fundamentally standalone (algorithm only) performance evaluations of the navigation system's precision, without direct human-in-the-loop variable performance being assessed in these specific metrics. The human factors testing assesses usability with humans, but the precision measurements themselves are of the system.

7. The Type of Ground Truth Used

For System Accuracy (Positional and Trajectory Error): The ground truth was established by comparing the "actual and virtual screw tip position, and the difference between the screw orientation and its recorded virtual trajectory." This implies a measurement against a known physical ground truth (actual screw placement) compared to the system's virtual representation.
For Clinical Accuracy (Gertzbein-Robbins score): The ground truth was established by "viewing the post-op scans." This implies expert consensus/interpretation of post-operative imaging, typically CT scans, to evaluate the accuracy of screw placement in relation to the vertebral canal. This is a common clinical scoring system.

8. The Sample Size for the Training Set

The document describes performance testing for a medical device, not explicitly an AI model that requires a "training set" in the machine learning sense. The software mentioned (OnPoint Augmented Reality Spine System Software) is part of a navigation system, not a deep learning model that would typically undergo a separate training and validation split. Therefore, a "training set" as understood in AI/ML is not applicable or mentioned in this context. The testing described focuses on system accuracy, software verification, and human factors, which are standard for surgical navigation devices.

9. How the Ground Truth for the Training Set Was Established

As a "training set" for an AI/ML model is not applicable to the device description in the document, this question is not relevant based on the provided information.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K231284

Device Name OnPoint Augmented Reality Spine System

Indications for Use (Describe)

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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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 120Bedford, 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 Instrument21 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.

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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

. Target position and orientation of toolpath
. Current position and orientation of instrument
. Cross sectional images
. 3D model of the patient's spine

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 ●

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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 SpineSystem(this submission)	Predicate DeviceAugmedics Xvision Spine System(K220905)	Conclusion
Indications forUse	The OnPoint Augmented RealitySpine System, with OnPointAugmented Reality Spine Systemsoftware, is intended as an aid forprecisely locating anatomicstructures in either open orpercutaneous spine procedures.The use of the OnPoint AugmentedReality Spine System is indicated forany medical condition in which the	The Xvision Spine System, withXvision Spine System Software, isintended as an aid for preciselylocating anatomical structures ineither open or percutaneous spineprocedures. Their use is indicatedfor any medical condition in whichthe use of stereotactic surgery maybe appropriate, and where referenceto a rigid anatomical structure, such	Same intended use. Thepredicate has slightlydifferent wording.
	use of stereotactic surgery may be	as the spine or pelvis, can be
	appropriate, and where reference to	identified relative to CT imagery ofthe 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 trackedinstrument location in relationship tothe stereotaxic display of the CTimages of the anatomy.	patient imagery. The virtual screenis indicated for displaying the virtualinstrument location in relation to the
Characteristic	OnPoint Augmented Reality Spine System(this submission)	Predicate DeviceAugmedics 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 implantprocedures	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 UserPopulation	Orthopedic surgeons or neurosurgeons	Orthopedic surgeons or neurosurgeons	Same
Intended UseEnvironment	Operating Room	Operating Room	Same
SystemComponents	● 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 CrestPin• Workstation cart with computer,tracking camera, router,monitors, keyboard, anduniversal power supply	• Instrument adaptors• Reference point: Patientclamp and perc pin• Accessories: Panel PC, rollstand, 8" tablet (Remote UI)	principles of operationare still the same.
Modes ofOperation	• 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 minordifferences between themodes of operations, butthe general workflowfollows standard surgicaltechnique.
LocalizationTechnology	Optical	Optical	Same
Optical Tracker	Infrared cameras, positioned 2-3meters from the surgical site	Single infrared camera, positioned0.5m above tracked objects	Similar. The position ofthe tracking camera isdifferent due the trackingcamera location.
Tracking	6 DOF	6 DOF	Same
SystemAccuracyRequirement	System Level Accuracy with a mean3D positional error of 2.0mm andmean trajectory error of 2°	System Level Accuracy with a mean3D positional error of 2.0mm andmean trajectory error of 2°	Same
ImagingModality	X-Ray Based Imaging	X-Ray Based Imaging	Same
Medical DeviceInterfaces	• O-arm Imaging System byMedtronic• Airo TruCT system by Stryker• Globus Excelsius 3D	• O-arm Imaging System byMedtronic• 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 thepredicate is cleared for abroader range of deviceinterfaces, OnPointSurgical is going tosupport the O-Arm, theAiro, and theExcelsius3D.
DisplayFeatures	• 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 instrumentmovement	Same.
CommunicationbetweenScanner	USB & LAN connectivity usingDICOM	USB & LAN connectivity usingDICOM	Same.
Characteristic	OnPoint Augmented Reality SpineSystem(this submission)	Predicate DeviceAugmedics Xvision Spine System(K220905)	Conclusion
and Platform/ComputerDisplay andOpticsTechnology	Augmented Reality using neareye see-through display Workstation monitors	Augmented Reality using neareye see-through display Workstation monitor	Same.
Communicationbetween OHMDand Computer	Wireless, encrypted	Wireless, encrypted	Same.
SupportedFrequencies &TransmissionProtocol	2.4GHZ & 5 GHz802.11g/n/ac	2.4GHZ & 5 GHz802.11g/n/ac	Same
Frame Rate ofDisplayedImages	60 fps	60 fps	Same
OHMD Field ofView	~52 degree FoV, 42 pixels perdegree (PPD)	32.50 (vertical) X 180 (horizontal)	Similar. The OnPointOHMD has a larger FoVwhich should result inless peripheral visionrisk.
OHMDResolution	3840 by 1080 pixels (1920x1080 pereye)	1280x720 per eye	Similar. The OnPointOHMD has more pixelswhich should result in aclearer display.
OHMD PowerSource	Li-ion rechargeable battery	Li-ion rechargeable battery	Same.
Number ofSupportedOHMDs	Three	Two	Similar. The OnPointAugmented Reality SpineSystem can support upto 3 headsets at onetime.
Rigid ReferencePoint	Spinal clamp with spinal arrayis attached to the spinousprocess Iliac crest pin is inserted intoposterior superior iliac spine(PSIS) with adapter for spinalarray	Patient clamp attached to thespinous process Perc pin inserted into the PSIS	Similar. The rigidreference points are thesame with respect towhere they touch thepatient and their intendedfunction. There may bedifferences with how thetracking arrays areattached.
Instrument(Tool)Adaptors	Reusable Universal and power instrumentadapters (connects to variousrotating 3rd party instruments) System specific adapters to	Reusable Universal (connects to variousinstruments) - not systemspecific VP & Ergonomic (systemspecific adaptors)	Similar. The instrumentadapters allow trackingarrays to be connected to3rd party devices. Theremay be minor differencesin the connection
Characteristic	OnPoint Augmented Reality SpineSystem(this submission)	Predicate DeviceAugmedics Xvision Spine System(K220905)	Conclusion
	connect to the 3rd partyinstrument• Fixed adapters that connect toinstruments that do not rotate		mechanisms and/orinstrument 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.

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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.

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K231284

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.

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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.

Regulation Number and Section

§ 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).