The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as:

· Pedicle Screw Placement (Thoracic and Lumbosacral spine)
Iliosacral Screw Placement

The NextAR Spine platform is intended to be used in combination with NextAR™Struments and / or Medacta preoperative planning. In the case of pre-operative planning software is used pre-operatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

Device Description

The NextARTM Spine Platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:

navigation software which displays information to the surgeon; ●
Augmented Reality glasses:
optical tracking system;
PC based hardware platform; ●
Fiducial Block;
Adaptor for sensor:
Spine attachment instruments ●
Reusable surgical instruments for spine surgery procedures.

The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block and a group of pins and drills are provided sterile.

The NextAR™ Spine Platform aid the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor.

The NextAR Spine system is a surgical navigation platform which uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D-CArm scan in order to register the spine to navigation elements.

The registration can be performed with one of the following approaches:

. Direct 3D: based on the use of an intra-operative 3D-CArm scan
. 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D-CArm scan

The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.

AI/ML Overview

The provided document describes the FDA 510(k) clearance for the Medacta NextAR™ Spine Platform. Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with specific numerical targets and measured device performance in the format requested. Instead, it states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." It then lists the types of studies performed that would have generated data to demonstrate meeting these criteria.

However, based on the scope of the device (surgical navigation system for pedicle screw placement), the primary performance metric of interest for evaluating stereotaxic instruments is accuracy, specifically the deviation of the navigated instrument from the planned trajectory or anatomical landmark. While a specific numerical value for "accuracy" is mentioned as a shared characteristic with the predicate device, it is not explicitly quantified as an acceptance criterion in the provided text.

Inferred Information:

Acceptance Criteria (Inferred from device type and studies)	Reported Device Performance (Implied by clearance)
Accuracy (Mechanical and Optical)	Demonstrated to be substantially equivalent to predicate devices. Benchtop accuracy verification conducted.
Software Verification and Validation	Successfully completed.
Performance Testing (Mechanical and Optical Properties)	Successfully completed.
Clinical Performance (Cadaveric Study)	Demonstrated that the device aids in precisely locating anatomical structures for pedicle and iliosacral screw placement.

2. Sample Size for Test Set and Data Provenance

Test Set (Cadaver Validation Study): The document states that a "cadaver validation study" was performed. However, it does not specify the sample size (e.g., number of cadavers, number of vertebrae, or number of screw placements) used for this study.
Data Provenance: The document does not explicitly state the country of origin. Given the manufacturer, Medacta International SA, is based in Switzerland, data could originate from there or other regions where testing facilities are available. It is a prospective study as it involves active testing on cadavers.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth for the test set or their qualifications. For cadaveric studies involving screw placement, ground truth would typically be assessed by experienced surgeons or radiologists.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. This type of study is more common for diagnostic AI tools and less directly applicable to a surgical navigation platform focused on physical precision.

6. Standalone (Algorithm Only) Performance Study

The document describes the NextAR™ Spine Platform as a surgical navigation platform that aids the surgeon. While it has algorithms for registration and visualization, its intended use is with a human in the loop. The "benchtop accuracy verification" and "cadaver validation study" would evaluate the system's performance, but it's not explicitly framed as a "standalone algorithm only" study in the sense of a diagnostic AI system without human input. The navigation software displays information to the surgeon, implying human interaction is integral.

7. Type of Ground Truth Used

For the "cadaver validation study," the ground truth would typically be established based on:

Expert Consensus/Assessment: Post-procedure evaluation by surgeons or imaging specialists using high-resolution imaging (e.g., CT scans) to determine the actual trajectory and position of implanted screws relative to anatomical landmarks or intended trajectories.
Imaging Data: Post-operative imaging (like CT scans) would be compared against the pre-operative plan and intra-operative navigation data to assess accuracy.

The document does not explicitly state the type of ground truth used, but these are standard practices for such studies.

8. Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. Surgical navigation systems like NextAR Spine typically rely on principles of image processing, stereotaxy, and 3D registration that are established algorithms, rather than deep learning models that require large proprietary training datasets in the same way an AI diagnostic tool would. If machine learning components are present, information on their training would be missing.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established.

Summary

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July 21, 2023

Medacta International S.A. % Chris Lussier Senior Director, Quality, Regulatory, and Clinical Research Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K223769

Trade/Device Name: NextAR Spine Platform Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, JWH, PBF Dated: June 21, 2023 Received: June 22, 2023

Dear Chris Lussier:

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 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) K223769

Device Name NextAR™ Spine Platform

Indications for Use (Describe)

· Pedicle Screw Placement (Thoracic and Lumbosacral spine)
Iliosacral Screw Placement

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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter I.

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Baj, Regulatory Affairs Director, Medacta International SA Applicant Correspondent: Christopher Lussier, Sr. Director, Quality and Regulatory, Medacta USA Date Prepared: July 21, 2023

II. Device

Device Proprietary Name:	NextAR™ Spine Platform
Common or Usual Name:	Navigation System
	Total Joint Replacement
Classification Name:	Stereotaxic Instrument
Primary Product Code:	OLO
	JWH
	PBF
Regulation Number:	21 CFR 882.4560
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary predicate device:

NextARTM Spine Platform K210859, Medacta International SA .
Reference devices:
. Xvision Spine (XVS), K211188, Augmedics Ltd

IV. Device Description

The NextARTM Spine Platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components:

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navigation software which displays information to the surgeon; ●
Augmented Reality glasses:
optical tracking system;
PC based hardware platform; ●
Fiducial Block;
Adaptor for sensor:
Spine attachment instruments ●
Reusable surgical instruments for spine surgery procedures.

The NextAR™ Spine Platform aid the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor.

The registration can be performed with one of the following approaches:

. Direct 3D: based on the use of an intra-operative 3D-CArm scan
. 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D-CArm scan

V. Indications for Use

The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open/mini-open or percutaneous spine procedures. It is indicated for any medical condition in which the use of stereotaxic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include posterior approach spinal procedures, such as:

· Pedicle Screw Placement (Thoracic and Lumbosacral spine)
Iliosacral Screw Placement

The NextAR Spine platform is intended to be used in combination with NextAR™ Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning,

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surgical planning software is used pre-operatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

VI. Comparison of Technological Characteristics

The NextAR™ Spine System and the predicate NextAR™ Spine Platform, K210859, share the following characteristics:

principle of operation; ●
user interface: ●
power source; ●
optical tracking system;
platform: ●
use of surgical instruments for navigation;
main system components;
accuracy;
computer hardware;
pre-operative patient anatomy data acquisition; ●
intra-operative patient anatomy data acquisition. ●

The NextAR™ Spine Platform and the predicate Xvision Spine K211188 share the following characteristics:

Imaging Modality ●
Displaying Technology
Glasses communication; ●
. Use of surgical instruments for navigation;

Discussion

The differences between the subject and the primary predicate device are concerning the anatomical views in the AR glasses, glasses communication and the use, as optional, the universal camera adapter.

They do not raise different questions of safety or effectiveness when compared to the predicate device. Both navigation systems utilize stereotaxic technologies.

Minor differences are addressed by performing cadaveric testing/ rational/ test.

VII. Performance Data

Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following studies were performed in support of a substantial equivalence determination:

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software verification and validation; ●
. benchtop accuracy verification;
performance testing to evaluate mechanical and optical properties; and ●
. cadaver validation study.

VIII. Conclusion

The information provided above supports that the NextAR™ Spine Platform is substantially equivalent to the identified predicate device.

Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations. The NextAR™ Spine Platform can be considered substantially equivalent to the identified 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).