Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally invasive spinal surgical procedures. Instruments and implants tracked by a passive marker sensor system are virtually displayed on a patient's 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the acquired image of the anatomy.

This may include the following spinal implant procedures:

Pedicle Screw Placement (cervical, thoracic, lumbar)
Iliosacral screw placement

Device Description

The subject device, Pulse ICT Adapter is introducing compatibility based on the design of existing fria patient reference hardware, the Spinous Process Clamp (Pulse System K210574) and Globus Medical 1CT Fixture (ExcelsiusGPS K171651 and K 191100). The subject device, Pulse ICT Adapter was designed to offer surgeons more flexibility during the registration process of Pulse Navigation by providing an additional patient reference hardware design option by attaching Globus Medical Intra-Op CT Fixture to the following: existing Articulating Arm and Bedrail Clamp. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device is substantially equivalent to the predicate as demonstration and validation testing performed using well established and previously cleared test methods.

The Pulse System is a medical device consisting of Pulse LessRay, and Pulse Navigation. The Pulse System hardware includes a control unit, as well as accompanying accessory components.

The Pulse NVM5 is a medical device that is intraoperative neurological monitoring and status assessment during spinal surgery. The device provides information directly to the surgeon, to help assess a patient's neurological status. The Pulse NVMS provides this information by electrically stimulating nerves via electrodes located on surgical accessories and monitoring electromyography (EMG), motor evoked potential (MEP) or somatosensory evoked potential (SSEP) responses of the muscle groups innervated by the nerves. Moreover, a Twitch Test ("Train of Four") function is utility of the nerve to respond, or contract, following four stimulation pulses to determine the presence of neuromuscular block.

Additionally, the Pulse NVM5 System includes a software function that measures spinal parameters and acquires the location of spinal implants (screws, hooks) to assist the surgeon in bendini). Lastry, the Pulse NVMS provides Remote Access in two pathways, Local Wireless Control and Remote Monitoring.

Pulse LessRay is a software application which can be interfaced to a fluoroscope with a video cable. The images produced by the fluoroscope are transmitted to a frame grabber in the computer running LessRay where the images are enhanced and then displayed. When used in connection with the low dose and/or pulse setting on the fluoroscope, the user can improve the quality (clarity, contrast, noise level, and usability) of a noisy (low-quality) image. Using this system, much of the graininess of low radiation dose images can be eliminated. This allows for greater utility of low dose imaging. LessRay provides the additional feature of being able to interface LessRay with a tracking system in order to aid the C-arm technician in positioning the fluoroscope between the various views of the patient necessary for the intervention. LessRay with Tracking ensures that the fluoroscope is centered over the correct anatomy prior to taking any additional x-ray images.

Pulse Navigation is a stereotactic surgical as an aid for precisely locating anatomical structures in either open or percutaneous procedures. It is intended for intraoperative image-guided localization which allows for surgical instruments to be tracked in three-dimensional space. The device provides real-time information directly to the surgeon to evaluate the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in threedimensional space with an Infrared (IR) Camera, being virtually displayed and superimposed on registered radiographic images. Radiographic images are in the form of 3D intraoperative scan (CT or Cone Beam CT).

The reason for the submission is to introduce a new intra-operative CT (ICT) adapter for use with the ExcelsiusGPS ICT Registation Fixture for the Pulse Navigation application.

AI/ML Overview

The provided documentation (K243814) describes the NuVasive Pulse System (specifically, the Pulse ICT Adapter), a stereotaxic instrument for image-guided spinal surgery. The submission focuses on introducing a new intra-operative CT (ICT) adapter for use with the ExcelsiusGPS ICT Registration Fixture for the Pulse Navigation application.

The document does not provide a comprehensive study proving the device meets specific acceptance criteria in the format requested (e.g., performance metrics like sensitivity, specificity, or accuracy compared to a ground truth established by experts). Instead, it focuses on demonstrating substantial equivalence to predicate devices through verification testing.

However, based on the information provided, we can infer some aspects related to acceptance criteria and the testing performed.

Here's an attempt to answer your questions based on the available text:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific quantitative acceptance criteria or detailed performance results in the usual sense (e.g., sensitivity, specificity, accuracy for a diagnostic AI). Rather, it states that "the subject Pulse System meets product and software for the system and satisfies the same acceptance criteria as the predicate device."

The performance testing mentioned is primarily focused on verification and validation to ensure compliance with design specifications and user needs, particularly regarding tracking accuracy and usability.

Acceptance Criteria (Inferred/General)	Reported Device Performance
Compliance with design specifications	"The results of testing demonstrated that the subject Pulse System meets product and software [requirements] for the system."
Compliance with user needs	"Non-clinical system, software, and instrument verification and validation demonstrated compliance with user needs and corresponding design inputs." and "Qualitative validation to confirm intended use."
Tracking Accuracy	"Testing was performed to ensure compliance with recognized standards mentioned below for tracking accuracy..." Specifically, ASTM F2554-10: Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems is cited. The actual measured accuracy values are NOT provided in this document.
Usability	"Testing was performed to ensure compliance with recognized standards mentioned below for... usability." Specifically, IEC 62366:2020 Medical devices Part 1: Application of usability engineering to medical devices is cited. Detailed usability test results are NOT provided.
Software Lifecycle Processes and Safety	Compliance with IEC 62304:2015 Medical device software - Software lifecycle processes is mentioned, indicating adherence to software development and safety standards. No specific performance metrics for this are provided beyond general compliance.
Substantial Equivalence to Predicate Devices	"The results of testing demonstrated that the subject Pulse System... satisfies the same acceptance criteria as the predicate device." and "Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject device has been shown to be substantially equivalent to legally marketed predicate devices." This is the primary "performance" claim for regulatory clearance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify a "sample size" for a test set in terms of patient data or images (as would be common for AI/ML diagnostic devices). The testing described is non-clinical verification and validation. This would typically involve physical testing on phantoms or test setups rather than patient data.

Sample Size: Not specified in terms of patient cases. The testing would be on a sufficient number of test samples/setups to prove the specific engineering requirements and standards.
Data Provenance: Not applicable as it's non-clinical testing. The tests are performed in a laboratory/engineering environment.
Retrospective/Prospective: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This document describes a surgical navigation system, not a diagnostic AI that interprets images. Therefore, the concept of "experts establishing ground truth for a test set" in the radiological interpretation sense does not apply directly.

The "ground truth" for a surgical navigation system's accuracy would be established through precise metrological measurements using phantoms or physical setups, not expert human agreement on medical images.

For usability testing (IEC 62366), "users" (e.g., simulated surgeons or clinical personnel) would interact with the device, and their feedback/performance would be assessed, but this is different from establishing a diagnostic ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as this is not a study requiring expert adjudication of medical images.

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

No such MRMC study is described in this document. The device is a surgical navigation system, not an AI for image interpretation or a tool to assist human readers in diagnosis.

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

This also doesn't directly apply. The "algorithm" (Pulse Navigation) is inherently human-in-the-loop: it assists the surgeon. The "standalone" performance would be its tracking accuracy and computational correctness, which are assessed through the non-clinical verification as per ASTM F2554-10. The document states this testing was done to ensure the system meets its specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the aspects of the device discussed (tracking accuracy, usability), the "ground truth" would be established by:

Metrological standards: For tracking accuracy (e.g., using precise measurement tools and phantoms as per ASTM F2554-10). The true position would be known and deviations measured.
Engineering specifications and user requirements: For general system functionality and safety.
Usability engineering principles: For usability testing, where adherence to principles defined in standards like IEC 62366 is verified.

8. The sample size for the training set

This document does not describe an AI/ML device that undergoes a "training phase" on a dataset in the sense of deep learning or machine learning. The device is a hardware/software system that uses pre-defined algorithms for navigation and tracking. Therefore, there is no "training set" in the context of data-driven model learning.

9. How the ground truth for the training set was established

Not applicable as there is no "training set" in the AI/ML sense. The system's algorithms are developed based on established engineering principles and physics.

Summary

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January 10, 2025

Globus Medical, Inc Jennifer Antonacci Group Manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Ave Audubon, Pennsylvania 19403

Re: K243814

Trade/Device Name: Pulse ICT Adapter Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: December 11, 2024 Received: December 11, 2024

Dear Jennifer Antonacci:

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 (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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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) K243814

Device Name NuVasive Pulse System

Indications for Use (Describe)

This may include the following spinal implant procedures:

Pedicle Screw Placement (cervical, thoracic, lumbar)
Iliosacral screw placement

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:

A. Submitted by:

Prem Pisupati Lead Regulatory Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (858) 909-1800

Date Prepared: 08-Jan-2025

B. Device Name

Trade or Proprietary Name:	NuVasive® Pulse™ System
Common or Usual Name:	Stereotaxic Instrument
Classification Name:	Stereotaxic Instrument
Device Class:	Class II
Regulation Number:	21 CFR §882.4560
Classification Product Code:	OLO
Subsequent Product Codes:	PDQ, ETN, GWF, HAW, IKN, OWB, LLZ, JAA

C. Predicate Devices

Primary Predicate: NuVasive Pulse System (K210574) Other Predicates: ExcelsiusGPS (K171651 and K191100)

D. Device Description

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K243814

Navigation by providing an additional patient reference hardware design option by attaching Globus Medical Intra-Op CT Fixture to the following: existing Articulating Arm and Bedrail Clamp. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device is substantially equivalent to the predicate as demonstration and validation testing performed using well established and previously cleared test methods.

The Pulse System is a medical device consisting of Pulse LessRay, and Pulse Navigation. The Pulse System hardware includes a control unit, as well as accompanying accessory components.

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K243814

the instrument depth and trajectory for computer-assisted navigation during spine surgery. Instruments are tracked in threedimensional space with an Infrared (IR) Camera, being virtually displayed and superimposed on registered radiographic images. Radiographic images are in the form of 3D intraoperative scan (CT or Cone Beam CT).

The reason for the submission is to introduce a new intra-operative CT (ICT) adapter for use with the ExcelsiusGPS ICT Registation Fixture for the Pulse Navigation application.

E. Indications for Use

Pulse Navigation is intended as an intraoperative image-guided localization system in either open or minimally invasive spinal surgical procedures. Instruments and implants tracked by a passive mare virtually displayed on a patient's 3D radiographic image data. The system enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure to the acquired image of the anatomy.

This may include the following spinal implant procedures:

Pedicle Screw Placement (cervical, thoracic, lumbar)
Iliosacral screw placement

F. Technological Characteristics

The introduction of new hardware (the Pulse ) and a new registration algorithm in software allows an updated fiducial-based patient registration method, when used together with ExcelsiusGPS ICT fixture. The subject device is comparable to the predicates in terms of intended use, fundamental scientific technological characteristics and principles of operation.

Characteristics	Subject Device:NuVasive Pulse System Fiducialbased registration (ICT Fixture andPulse ICT adapter)	Predicate Device:NuVasive Spinous Process Clamp(K210574)	Predicate Device:Globus Medical Intra-op CTRegistration Fixture (ICT Fixture)ExcelsiusGPS (K171651 & K191100)
Principle ofOperation	Fiducial registration hardwareprovides a reference to a rigidanatomical structure.	Patient reference hardware providesa reference to a rigid anatomicalstructure.	Patient reference hardware thatprovides a reference to a rigidanatomical structure.
SystemComponents	Pulse ICT Adapter andExcelsiusGPS ICT Fixture are	Clamps directly attached tospinous process	ICT fixture attached to patientreference hardware via pivoting arm

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RegistrationCompatibility	attached to surgical bed viaarticulating arm and bedrail clamp
	Fiducial Registration	NaviLink and FiducialRegistration	Fiducial Registration

G. Performance Testing

Nonclinical testing was performed to demonstrate that the substantially equivalent to other predicate devices and to verify that the Pulse System meets design specifications and performance characteristics, based upon the intended use.

The Pulse System was subjected to the following verification testing acording to the product and software requirements specifications defined for the system.

· Non-clinical system, software, and instrument verification and validation demonstrated compliance with user needs and corresponding design inputs.
Qualitative validation to confirm intended use .
· Testing was performed to ensure compliance with recognized standards mentioned below for tracking accuracy and usability.
- = ASTM F2554-10: Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems
- IEC 62366:2020 Medical devices Part 1: Application of usability engineering to medical devices
- . IEC 62304:2015 Medical device software - Software lifecycle processes

The results of testing demonstrated that the subject Pulse System meets product and software for the system and satisfies the same acceptance criteria as the predicate device. Therefore, the subject Pulse System was found to be substantially equivalent.

H. Conclusions

Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject device has been shown to be substantially equivalent to legally marketed predicate devices.

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).