The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. It is indical for any medical condition in which the use of stereotaxtic 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 the following spinal implant 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™M Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning software is used preoperatively 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 aids the surgeon in executing the surgical plan by visualizing all the information in real time on 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

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:

1. Table of Acceptance Criteria & Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating numerical acceptance criteria for clinical performance. However, based on the performance data section, the device's accuracy was a key performance metric evaluated. The acceptance criteria for accuracy are not explicitly stated in numerical terms in this document, but the study described aimed to confirm its performance comparable to the predicate.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance
Accuracy	Comparable to predicate navigation systems in spine procedures.	"Accuracy test" was conducted and the "Cadaver study" supports the device's ability to precisely locate anatomical structures and aid in screw placement. While specific numerical accuracy metrics (e.g., error in mm) are not stated in this summary, the conclusion states substantial equivalence has been demonstrated through performance evaluations.
Software Validation	Software functions as intended and meets specifications.	Performed.
Biocompatibility	Meets ISO 10993-1:2009 standards.	Performed.
Sterilization Validation	Device can be effectively sterilized.	Performed.
Shelf-life Testing	Device maintains integrity over its shelf life.	Performed.
Shipping Test	Device withstands shipping conditions.	Performed.
Electrical Safety	Conforms to IEC 60601-1:2005 and amendments.	Performed.
Electromagnetic Compatibility (EMC)	Conforms to IEC 60601-1-2:2014.	Performed.
Mechanical & Optical Properties	Meets performance expectations.	Performed.

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

The document mentions a "Cadaver study" as part of the performance testing.

Sample Size: The exact number of cadavers used is not specified in the provided text.
Data Provenance: The study was a "Cadaver study," indicating it was conducted on human cadavers. This is a form of retrospective data in terms of patient-specific outcomes, as the cadavers represent once-living individuals, but the experimental setup is controlled like a prospective study. The country of origin is not specified.

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

The document does not provide details on the number of experts or their specific qualifications (e.g., radiologists with X years of experience) used to establish ground truth within the cadaver study. It states the system is intended to aid surgical placement, implying the ground truth would typically be related to the accuracy of instrument placement or trajectory relative to anatomical landmarks, ideally verified by expert assessment or post-procedure imaging analysis.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1) for the test set (cadaver study).

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 regarding human readers improving with AI vs. without AI assistance. The device is a navigation platform for surgeons, implying human-in-the-loop assistance, but a formal MRMC study as typically performed for diagnostic AI is not described.

6. Standalone (Algorithm Only) Performance:

The document does not explicitly describe a standalone (algorithm only without human-in-the-loop performance) study. The device is designed as a "surgical navigation platform" to "aid the surgeon" and display information "in real-time on a screen monitor," indicating an inherent human-in-the-loop design.

7. Type of Ground Truth Used:

For the "Accuracy test" and "Cadaver study" related to placement, the ground truth would likely involve:

Precise measurements of instrument tip position or trajectory relative to anatomical landmarks.
Verification using high-resolution imaging (e.g., CT scan) of the cadaver after "screw placement" to assess deviation from planned trajectories or ideal anatomical placement.
The document does not explicitly state the method for establishing ground truth, but for a navigation system, it would generally be based on anatomic truth verified by imaging or detailed measurements.

8. Sample Size for the Training Set:

The document does not provide any information regarding the sample size for a training set. As a substantial equivalence determination, the focus is on performance testing and comparison to predicates, not on the details of algorithmic training. The "Dedicated algorithm" is mentioned as a technological characteristic, implying machine learning components, but its training details are not disclosed here.

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

Since there is no information on a training set, the document does not provide details on how its ground truth was established.

Summary

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November 5, 2021

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: on the left, there is a seal of the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's role in protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.

Medacta International, SA % Chris Lussier Senior Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis. Tennessee 38118

Re: K210859

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: September 29, 2021 Received: September 30, 2021

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 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.

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) K210859

Device Name NextAR™ Spine Platform

Indications for Use (Describe)

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

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

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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510(k) Summary

I. Submitter

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: Chris Lussier, Sr. Director of Quality and Regulatory, Medacta USA Date Prepared: March 22, 2021 Dave Revised: November 4, 2021

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
	BPF
Regulation Number:	21 CFR 882.4560
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary predicate device:

Stealth Station System, K170011, Medtronic ●
Additional predicate devices:
. NextARTM TKA Platform K193559, Medacta International SA
NextARTM TKA Platform K202152, Medacta International SA ●

Reference predicate devices:

M.U.S.T. Pedicle Screw System, K121115, Medacta International SA ●
M.U.S.T. Pedicle Screw System, K132878, Medacta International SA ●
M.U.S.T. Pedicle Screw System, K141988, Medacta International SA ●
M.U.S.T. Pedicle Screw System, K162061, Medacta International SA ●
M.U.S.T. Pedicle Screw System, K171170, Medacta International SA ●
M.U.S.T. Pedicle Screw System, K171369, Medacta International SA ●

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M.U.S.T. Pedicle Screw System, K171595, Medacta International SA ●
. M.U.S.T. Pedicle Screw System, K193365, Medacta International SA

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:

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 aids the surgeon in executing the surgical plan by visualizing all the information in real time on 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.

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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 stereotaxtic 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 the following spinal implant 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, 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 NextARTM Spine Platform and the predicate- Stealth Station system, K170011, share the following characteristics:

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

The NextAR™ Spine Platform and the predicate NextAR™ TKA Platform K193559 and K202152 share the following characteristics:

power source; ●
optical tracking system ●
platform; ●
use of surgical instruments for navigation; ●

The NextAR™ Spine Platform and the predicate Stealth Station system, K170011, are technologically different with respect to:

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Active infrared Camera Target vs Passive infrared Camera Target ●
The NextAR™ Spine Platform and the predicate NextAR™ TKA Platform K193559 and K202152 are different with respect to:
Intended use and indication ●
Surgical flow ●
intra operative scan
Dedicated algorithm ●
Target dimension ●

Discussion

There are minor differences between the subject and predicate devices; these differences are concerning optical tracking system, dedicated algorithm and intended use. 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 and rational testing.

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:

Software validation: ●
Accuracy test ●
Biocompatibility per ISO 10993-1:2009; ●
Sterilization validation; ●
Shelf-life testing: ●
Shipping test ●
Electrical safety testing per IEC 60601-1:2005, COR1:2006, COR2:2007, Amd1:2012; ●
Electromagnetic compatibility testing per IEC 60601-1-2:2014; ●
Performance testing to evaluate mechanical and optical properties. ●
Cadaver study. ●

VIII. Conclusion

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

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 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).