The HOLO Portal™ Surgical Guidance System is indicated as an aid for precisely locating anatomical structures in either open or percutaneous orthopedic procedures in the lumbosacral spine region. Their use is indicated for any medical condition of the lumbosacral spine in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the iliac crest, can be identified relative to intraoperative CT images of the anatomy.

The HOLO Portal™ Surgical Guidance System simultaneously displays 2D stereotaxic data along with a 3D virtual anatomy model over the patient during surgery. The stereotaxic display is indicated for continuously tracking instrument position and orientation to the registered patient anatomy while the 3D display is indicated for localizing the virtual instrument to the virtual anatomy model over the patient during surgery. The 3D display should not be relied upon solely for absolute positional information and should always be used in conjunction with the displayed 2D stereotaxic information.

Device Description

The HOLO Portal™ System is a combination of hardware and software that provides visualization of the patient's internal anatomy and surgical guidance to the surgeon based on patient-specific digital imaging.

HOLO Portal™ is a navigation system for surgical planning and/or intraoperative guidance during stereotactic surgical procedures. The HOLO Portal™ System consists of two mobile devices: 1) the surgeon workstation, which includes the display unit and the augmented reality visor (optional), and 2) the control workstation, which houses the optical navigation tracker and the computer. The optical navigation tracker utilizes infrared cameras and active infrared lights to triangulate the 3D location of passive markers attached to each system component to determine their 3D positions and orientations in real time. Software algorithms combine tracking information and high-resolution 3D anatomical models to display representations of patient anatomy, compared to traditional two-dimensional (2D), displays during surgical procedures.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the HOLO Portal™ Surgical Guidance System, primarily focusing on performance testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "positional error must be less than X mm"). Instead, the document refers to "worst-case" measurements and relies on clinical meaningfulness relative to the predicate. The performance data is summarized in tables.

Metric	Performance Validation (Cadaver) - Mean	Performance Validation (Cadaver) - Standard Dev.	Performance Validation (Cadaver) - 95% CI Upper Bound	Performance Validation (Cadaver) - 99% CI Upper Bound	Performance Verification (Benchtop) - Mean	Performance Verification (Benchtop) - Standard Dev.	Performance Verification (Benchtop) - 95% CI Upper Bound
Positional Error [mm]	2.37	0.72	2.58	2.69	1.54	0.74	1.75
Angular Error [degrees]	1.40	0.84	1.65	1.73	1.50	0.68	1.69

Acceptance Criteria Implied: The device must meet "performance requirements under the indications for use" and demonstrate "equivalent safety and efficacy of the system to the cited predicate device." The provided numbers represent the achieved performance, which is presumably within acceptable limits for its intended use and considered substantially equivalent to the predicate. No explicit numerical acceptance thresholds are provided in the text.

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

Sample Size for Test Set: The document does not explicitly state the number of cadavers or benchtop phantoms used. It mentions "surgical simulations conducted on cadavers" and "rigid benchtop phantoms." It refers to "a set of test samples presenting lumbosacral spine, extracted from stationary and intraoperative Computed Tomography scans" for software validation. The number of measurements (which would be related to the sample size of "pedicle screws" or placements) is not provided.
Data Provenance: The document does not specify the country of origin for the data. The studies are described as "surgical simulations conducted on cadavers" and "rigid benchtop phantoms," and testing for software validation used "extracted from stationary and intraoperative Computed Tomography scans." It is retrospective in the sense that the CT scans for software segmentation were "extracted," but the practical "performance validation" and "verification" studies appear to be prospective experimental setups (cadaver labs, benchtop testing).

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

Number of Experts: For the software validation study of anatomical segmentation, the ground truth was established by "manual segmentations prepared by trained analysts." The specific number of analysts is not provided.
Qualifications of Experts: The experts are simply described as "trained analysts." No specific qualifications (e.g., radiologist, years of experience) are mentioned.

4. Adjudication Method for the Test Set

For the software validation (segmentation comparison), an adjudication method is not explicitly stated. The comparison was based on "mean Sørensen-Dice coefficient (DSC) calculations" against manual segmentations. This implies a direct quantitative comparison rather than a human-based adjudication process for discrepancies.
For the positional and angular error measurements in cadaver and benchtop testing, "the 3D (Euclidean) distance between the tips of the virtual and real implants" and "the angle between the 3D trajectories of the virtual and real implants" were measured. This is an objective measurement, not requiring human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with AI vs. without AI assistance was not explicitly mentioned or described in the provided text. The device is a surgical guidance system, not an AI for image interpretation that would typically involve a diagnostic reader study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, aspects of standalone performance were conducted:

Positional and Angular Error (Cadaver and Benchtop): These measurements assess the system's accuracy in tracking and guiding, which is a standalone performance metric of the system itself in a controlled environment.
Software Validation (Segmentation): "A set of test samples presenting lumbosacral spine... was subjected to the autonomous spine segmentation process performed by the HOLO Portal System." The quality was determined by comparing the system's segmentation to manual ground truth. This is a clear example of standalone algorithm performance testing.

7. The Type of Ground Truth Used

For Positional/Angular Error (Cadaver and Benchtop): The ground truth was based on the "real implants" or "real pedicle screws" placed, with measurements taken relative to these physical realities. This could be considered a form of objective measurement against physical reality.
For Software Segmentation: The ground truth was "manual segmentations prepared by trained analysts." This is expert consensus/manual annotation based ground truth.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the HOLO Portal™ Surgical Guidance System's software, including the autonomous spine segmentation process.

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

The document does not provide information on how the ground truth for the training set was established. It only describes the establishment of ground truth for the test set (manual segmentations by trained analysts).

Summary

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August 31, 2023

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Surgalign Spine Technologies Jeremy Markovich Senior Director, Regulatory Affairs 520 Lake Cook Road Suite 315 Deerfield, Illinois 60015

Re: K231611

Trade/Device Name: HOLO Portal™ Surgical Guidance System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: June 1, 2023 Received: June 2, 2023

Dear Jeremy Markovich:

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.

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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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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For Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231611

Device Name HOLO Portal™ Surgical Guidance System

Indications for Use (Describe)

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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K231611

510(k) Summary: HOLO Portal™ Surgical Guidance System

Company:	Surgalign Spine Technologies, Inc.
Contact:	Alanna JoshiSurgalign Spine Technologies, Inc.520 Lake Cook Road Suite 315Deerfield, IL 60015630-227-3809
Date Prepared:	August 31, 2023
Proprietary Name:	HOLO Portal™ Surgical Guidance System
Common Name:	Stereotaxic Instrument
Classification:	21 CFR 882.4560Product Code(s): OLO, LLZClass II
Primary Predicate:	ARAI Surgical Navigation System (K211254)

Indications for Use:

Device Description:

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the surgeon workstation, which includes the display unit and the augmented reality visor (optional), and 2) the control workstation, which houses the optical navigation tracker and the computer. The optical navigation tracker utilizes infrared cameras and active infrared lights to triangulate the 3D location of passive markers attached to each system component to determine their 3D positions and orientations in real time. Software algorithms combine tracking information and high-resolution 3D anatomical models to display representations of patient anatomy, compared to traditional two-dimensional (2D), displays during surgical procedures.

The following modifications have been applied to the previously cleared ARAI Surgical Navigation System (K211254):

Additional compatibility capabilities have been added to the system. Clearance of this 510(k) will allow the HOLO Portal System to be compatible with the following components:

Ziehm Vision RFD 3D Scanner (K202360) ●
. GE OEC 3D Scanner (K203346)
NDI Polaris Vega XT Camera .

Summary of Technological Characteristics:

The modified HOLO Portal™ Surgical Guidance System has the same technological characteristics as its predicate device, the cleared ARAI Surgical Navigation Systems have the same design, materials, performance characteristics, and the same or equivalent labeling. Both systems include very similar hardware and software components with the following basic components: software, optical tracking camera, single use passive reflective markers, rigid reference point, reusable instrument arrays, and 2D and 3D augmented reality (AR) display. The software in both systems is designed for real time calculation and display of spatial position of the tip of surgical instruments relative to patient's anatomy. The HOLO Portal™ is comparable to the predicate in terms of intended use, fundamental scientific technology, technological characteristics, and principle of operation.

A table comparing the key features of the subject and predicate devices is provided below:

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Comparison of the Principles of Operation and Technological Characteristics

Features	HOLO Portal™ System	ARAIT™ Surgical Navigation System
510(k) number	Subject Device	K211254
Product Code	OLO, LLZ	OLO, LLZ
Indications for Use	The HOLO Portal™ Surgical Guidance System is indicated as an aidfor precisely locating anatomical structures in either open orpercutaneous orthopedic procedures in the lumbosacral spine region.Their use is indicated for any medical condition of the lumbosacralspine in which the use of stereotactic surgery may be appropriate, anwhere reference to a rigid anatomical structure, such as the iliac crest,can be identified relative to intraoperative CT images of the anatomy.The HOLO Portal™ Surgical Guidance System simultaneouslydisplays 2D stereotaxic data along with a 3D virtual anatomy modelover the patient during surgery. The stereotaxic display is indicatedfor continuously tracking instrument position and orientation to theregistered patient anatomy while the 3D display is indicated forlocalizing the virtual instrument to the virtual anatomy model over thepatient during surgery. The 3D display should not be relied uponsolely for absolute positional information and should always be usedin conjunction with the displayed 2D stereotaxic information.	The ARAI™ System is intended as an aid for precisely locatinganatomical structures in either open or percutaneous orthopedicprocedures in the lumbosacral spine region. Their use is indicated forany medical condition of the lumbosacral spine in which the use ofstereotactic surgery may be appropriate, and where reference toa rigid anatomical structure, such as the iliac crest, can beidentified relative to intraoperative CT images of the anatomy.The ARAI System simultaneously displays 2D stereotaxic data alongwith a 3D virtual anatomy model over the patient during surgery.The stereotaxic display is indicated for continuously trackinginstrument position and orientation to the registered patient anatomywhile the 3D display is indicated for localizing the virtual instrumentto the virtual anatomy model over the patient during surgery. The 3Ddisplay should not be relied upon solely for absolute positionalinformation and should always be used in conjunction with thedisplayed 2D stereotaxic information.
User Population	Orthopedic surgeons or neurosurgeons	Orthopedic surgeons or neurosurgeons
Intended Use Environment	Operating room	Operating room
Main System Components	AR glassesSoftware applicationTracking cameraSingle use passive reflective markersRigid reference pointReusable instrument arrays2D and 3D augmented reality display	AR glassesSoftware applicationTracking cameraSingle use passive reflective markersRigid reference pointReusable instrument arrays2D and 3D augmented reality display
Modes of Operation	Patient PreparationSystem Set-upIntraoperative Scan	Patient PreparationSystem Set-upIntraoperative Scan
Features	HOLO Portal™ System	ARAI™ Surgical Navigation System
	Scan Import	Scan Import
	Patient Registration	Patient Registration
	Navigation	Navigation
	2D axial, sagittal, and coronal	2D axial, sagittal, and coronal
	3D anatomical model	3D anatomical model
	Mesh Mode	Mesh Mode
	3D, 2D anatomic orthogonal planes	3D, 2D anatomic orthogonal planes
	Trajectories	Trajectories
	Trajectory guidance	Trajectory guidance
View(Display Features)	Look Ahead	Look Ahead
	Instrument's tip view	Instrument's tip view
	Clipping tool	Clipping tool
	Image Intensity	Image Intensity
	3D transparent	3D transparent
	User defined	User defined
	Implant	Implant
	AR OFF (3D OFF)	AR OFF (3D OFF)
	The HOLO Portal™ Software functionality is described interms of its feature sets which are categorized as imagingmodalities, registration, planning, interfaces with medicaldevices, and views. Feature sets include functionality thatcontributes to clinical decision making and are necessary toachieve system performance.	The ARAI Software functionality is described in terms of itsfeature sets which are categorized as imaging modalities,registration, planning, interfaces with medical devices, andviews. Feature sets include functionality that contributes toclinical decision making and are necessary to achieve systemperformance.
Software operating principle
Localization Technology andTracker	Optical - infrared 6 DOF NDI Polaris Vega XT Camera OptiTrack V120: Trio	Optical - infrared 6 DOF OptiTrack V120: Trio


	Automatic 3D Image Registration performed after placing apositional reference over the patient's anatomy and scanningthe surgical field with an intraoperative scanner.	Automatic 3D Image Registration performed after placing apositional reference over the patient's anatomy and scanningthe surgical field with an intraoperative scanner.
Registration features
Segmentation and 3D modelgeneration	Voxels of medical datasets (DICOM format) that correspondto the spine are automatically segmented and converted to apolygonal mesh for displaying purposes.	Voxels of medical datasets (DICOM format) that correspondto the spine are automatically segmented and converted to apolygonal mesh for displaying purposes.

Medical imaging rendering	Polygonal mesh	Polygonal mesh
Features	HOLO Portal™ System	ARAI™ Surgical Navigation System

Imaging Modality	X-Ray Based Imaging	X-Ray Based Imaging
Medical Device Interfaces	O-arm Imaging System Ziehm Vision RFD Scanner GE OEC 3D Scanner	O-arm Imaging System
CommunicationbetweenScanner andplatform/computer	Encrypted USB for DICOM	Encrypted USB for DICOM import & export with MedtronicO-arm
Display and Optics Technology	Augmented Reality using near eye see-through display; datadisplayed on patient's anatomy	Augmented Reality using near eye see-through display; datadisplayed on patient's anatomy

Subiect Device and Predicate Comparison

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HOLO Portali

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Image /page/7/Picture/0 description: The image shows the logo for HOLO Portal. The logo is written in a sans-serif font and is a light blue color. The word "HOLO" is written in all capital letters, and the word "Portal" is written in a mix of upper and lower case letters. There is a trademark symbol to the right of the word Portal.

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Performance Testing:

Verification and validation testing was conducted on HOLO Portal™ Surgical Guidance System to confirm that the device meets performance requirements under the indications for use and to ensure equivalent safety and efficacy of the system to the cited predicate device: Non-clinical testing included system, software, and instrument verification and validation to demonstrate that the system can consistently meet the user needs, corresponding design inputs, and intended use:

. Non-clinical system, software, and instrument verification and validation - demonstrated compliance with user needs and corresponding design inputs.
Surgical simulations conducted on cadavers were performed for system validation. The . positional displacement is measured as the 3D (Euclidean) distance between the tips of the virtual and real implants, and the angular axis displacement is measured as the angle between the 3D trajectories of the virtual and real implants.

The worst-case 3D positional (measured in mm) and angular error (measured in degrees) between the real and virtual pedicle screws for performance validation is summarized below:

Performance Validation	Mean	StandardDev.	95% CIUpperBound	99% CIUpperBound
Positional Error [mm]	2.37	0.72	2.58	2.69
Angular Error [degrees]	1.40	0.84	1.65	1.73

. Surgical simulations conducted on rigid benchtop phantoms were performed for system verification. Phantoms were scanned, registered, and screws were placed using standard clinical workflows to verify the system accuracy and precision by removing the variation due to anatomical movements relative to the reference fixation. The worst-case 3D positional (measured in mm) and angular error (measured in degrees) between the real and virtual pedicle screws for performance verification is summarized below:

Performance Verification	Mean	Standard Dev.	95% CI UpperBound
Positional Error [mm]	1.54	0.74	1.75
Angular Error [degrees]	1.50	0.68	1.69

Additionally, bench top testing included subsystem testing per ASTM F2554-18. ●
Augmented Reality technical characteristics were demonstrated via performance testing of ● display latency and framerate, stereoscopic crosstalk, and spatial accuracy (a measurement of disparity between the visualization of a real and virtual objects) under varying user conditions.
. Compliance conformity assessments per:
- 1. IEC 60601-1 Medical electrical equipment. General requirements for basic safety and essential performance
- 1. IEC 60601-1-2 Medical electrical equipment. General requirements for basic safety and essential performance – Electromagnetic disturbances

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Biocompatibility:

The biocompatibility evaluation for HOLO Portal™ Surgical Guidance System has been conducted in accordance with FDA Guidance for Industry and FDA Staff, "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process', " June 16, 2016. The evaluation confirms that HOLO Portal™ System meets biocompatibility requirements.

Electrical Safety and Electromagnetic Compatibility:

Testing was performed to assure compliance with recognized safety standard, IEC 60601-1:2005, AMD1:2012, AMD2:2020, and standard for electrical safety and electromagnetic compatibility, IEC 60601-1-2:2020 Ed 4.1.

Software Verification and Validation Testing:

Software validation and verification testing was performed in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).

A set of test samples presenting lumbosacral spine, extracted from stationary and intraoperative Computed Tomography scans was subjected to the autonomous spine segmentation process performed by the HOLO Portal System. The quality of the autonomous anatomical segmentation applied by the HOLO Portal System was determined by comparing it with manual segmentations prepared by trained analysts based on mean Sørensen-Dice coefficient (DSC) calculations.

Basis of Substantial Equivalence:

HOLO Portal™ System has been found to be substantially equivalent to the predicate device with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports the substantial equivalence to the cited predicate device.

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).