The NextAR™ TKA Platform is intended to be used to support the surgeon during total knee replacement procedures by providing information on bone resections, ligaments behaviour, instruments and implants positioning.

The NextAR™ TKA Platform is intended to be used in combination with NextAR™ stereotaxic instruments and general surgical instruments to implant the GMK® Sphere Total knee system and perform ligament balancing. As an optional display, the smart glasses can be used auxiliary to the NextAR™ Platform to view the same 2D stereotaxic information as presented by the NextAR™ Platform.

The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

The MyKnee® NextAR™ cutting guides include a camera/target holder and a PSI MyKnee® cutting guide both for tibia and femur. The MyKnee® cutting guides must be used as anatomical cutting blocks specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. The use of MyKnee® NextAR™ cutting guides are applicable only for the "PSI-based" approach. MyKnee® NextAR™ TKA cutting guides are for single use only.

The NextAR™ stereotaxic instruments are intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR™ stereotaxic instruments, when registered with the MyKnee® NextAR™ TKA cutting guides, provide reference to a patient's rigid anatomical structures, such as the femur and tibia, that can be identified relative to pre-operative CT based planning.

Device Description

The NextAR™ TKA Platform is a CT based computer-assisted surgical navigation platform used in total knee replacement surgery and includes the following components:

navigation software which displays information to the surgeon in real-time;
Augmented Reality glasses:
optical tracking system;
PC based hardware platform;
MyKnee NextAR Cutting Blocks (PSI) - now an option
Reusable surgical instruments for total knee replacement procedures.

NextAR™ TKA Platform PSI based is available on the US market via the clearance - K193559.

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 markers. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of bones and instrumentation relative to preoperative data in real-time while performing the surgical procedure. The tracking sensors are provided sterile.

The NextAR™ TKA Platform PSI based and PSI free, aid the surgeon in executing the surgical plan by visualizing all of the information in real time via a monitor.

The approach currently cleared via K193559, is to utilize the NextAR™ TKA Platform - PSI for the placement of the implants by cutting the bones using the MyKnee® NextAR™ Cutting Blocks.

The subject of this submission is to add an optional approach for the surgeon to utilize the NextAR™ TKA Platform PSI free for the placement of the implants by cutting the bones using navigated, reusable surgical instrumentation (provided non-sterile). The registration of the CT scan on the patient's anatomy is performed by executing the NextAR registration algorithm.

The same reusable surgical instrumentation (provided non-sterile) that is guided by the tracking sensors can be used also for recut. Although the position of the implants can be validated to assess the correct execution of the planning; the surgeon can change the surgical plan intraoperatively by analyzing the 3D models of the patient, the CT scan, and the 3D geometry of the implants.

With this submission we are presenting the NextAR™ TKA Platform extension (PSI free) intended to be used in combination with NextAR™ stereotaxic instruments and general surgical instruments to implant the GMK® Sphere Total knee system and perform ligament balancing.

The surgeon can choose the desired approach, PSI-based (clearance - K193559) or PSI-free under submission.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NextAR™ TKA Platform, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not provide a specific table of numerical acceptance criteria with corresponding performance data. Instead, it broadly states that "performance testing to evaluate mechanical and optical properties" was conducted and "device accuracy" is a shared characteristic with the predicate.

The main performance evaluation cited for this submission is a cadaver study. The summary also mentions that "software validation" was conducted.

Acceptance Criteria Category	Reported Device Performance (as implied by the document)
Device Accuracy	Comparable to the predicate device (NextAR™ TKA Platform K193559). The cadaver study implicitly aims to demonstrate clinical accuracy for bone resections, ligament behavior, instrument, and implant positioning.
Software Validation	Conducted successfully. No specific metrics or acceptance criteria detailed in this summary.
Mechanical Properties	Performance testing conducted. No specific metrics or acceptance criteria detailed in this summary.
Optical Properties	Performance testing conducted. No specific metrics or acceptance criteria detailed in this summary.

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

Test Set Sample Size: The document explicitly mentions a "cadaver study" but does not specify the number of cadavers or the sample size used in this study.
Data Provenance: The cadaver study would typically be considered prospective data collection for the purpose of the study. The country of origin of the data is not specified.

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

The document does not provide details on the number of experts used to establish the ground truth for the cadaver study or their qualifications. For a surgical navigation system, ground truth would typically involve precise measurements or assessments by orthopedic surgeons or specialized technicians.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set in the cadaver study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or described in this 510(k) summary. This type of study is more common for diagnostic AI tools where human interpretation of images is a primary outcome. The NextAR™ TKA Platform is a surgical navigation system, where the AI assists the surgeon directly during the procedure, rather than for diagnostic reading.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not explicitly state whether a standalone performance study of the algorithm without human-in-the-loop was conducted. However, the nature of a surgical navigation system inherently involves human interaction. Performance testing (e.g., "device accuracy") would likely involve assessing the algorithm's output in the context of simulated or actual surgical use with human interaction. The "software validation" would cover the algorithmic performance in a controlled environment.

7. Type of Ground Truth Used

For the cadaver study, the ground truth would typically be established through direct, precise intraoperative measurements (e.g., using a coordinate measuring machine, highly accurate goniometers, or other measurement tools) to ascertain the actual bone resections, implant positions, and ligament balance achieved, which are then compared to the planned surgical outcomes and the guidance provided by the NextAR™ TKA Platform. The document does not explicitly state the specific method for ground truth establishment, but for this type of device, it would involve direct physical measurements.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size of a training set. This submission is for an "extension" (PSI-free approach) to an already cleared device (K193559). While the original development of the navigation software likely involved significant data for training machine learning components (if any), this particular 510(k) does not detail it.

9. How Ground Truth for the Training Set Was Established

Since the document does not provide information on a training set, it consequently does not describe how ground truth for a training set was established.

Summary

{0}------------------------------------------------

October 27, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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

Re: K202152

Trade/Device Name: NextAR TKA Platform Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, JWH, PBF Dated: July 31, 2020 Received: August 3, 2020

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.

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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

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

Sincerely,

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K202152

Device Name NextAR™ TKA Platform

Indications for Use (Describe)

The NextAR™ TKA Platform is intended to be used in combination with NextAR" stereotaxic instruments and general surgical instruments to implant the GMK® Sphere Total knee system ligament balancing. As an optional display, the smart glasses can be used auxiliary to the NextAR™ Platform to view the same 2D stereotaxic information as presented by the NextAR™ Platform.

The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

The MyKnee® NextAR" cutting guides include a camera/target holder and a PSI MyKnee® cutting guide both for tibia and femur. The MyKnee® cutting guides must be used as anatomical cutting blocks specific for a single patient anatomy, to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of bone before cutting. The use of MyKnee® NextAR™ cutting guides are applicable only for the "PSI-based" approach. MyKnee" NextAR" TKA cutting guides are for single use only.

The NextAR" stereotaxic instruments are intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, ligaments behavior, instrument and implant positioning. The NextAR" stereotaxic instruments, when registered with the MyKnee" NextAR" TKA cutting guides, provide reference to a patient's rigid anatomical structures, such as the femur and tibia, that can be identified relative CT based planning.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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, Director of Quality and Regulatory, Medacta USA Date Prepared: October 8, 2020

II. Device

Device Proprietary Name:	NextART™ TKA Platform
Common or Usual Name:	Navigation System
	Total Joint Replacement
Classification Name:	Stereotaxic Instrument
	Knee joint patellofemorotibial polymer/metal/polymer semi-
	constrained cemented prosthesis.
Product Codes:	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:

NextAR™ TKA Platform K193559 .

{4}------------------------------------------------

IV. Device Description

The NextAR™ TKA Platform is a CT based computer-assisted surgical navigation platform used in total knee replacement surgery and includes the following components:

navigation software which displays information to the surgeon in real-time; ●
Augmented Reality glasses: ●
optical tracking system; ●
PC based hardware platform;
. MyKnee NextAR Cutting Blocks (PSI) - now an option
Reusable surgical instruments for total knee replacement procedures. ●

NextAR™ TKA Platform PSI based is available on the US market via the clearance - K193559.

The NextAR™ TKA Platform PSI based and PSI free, aid the surgeon in executing the surgical plan by visualizing all of the information in real time via a monitor.

The approach currently cleared via K193559, is to utilize the NextAR™ TKA Platform - PSI for the placement of the implants by cutting the bones using the MyKnee® NextAR™ Cutting Blocks.

The surgeon can choose the desired approach, PSI-based (clearance - K193559) or PSI-free under submission.

{5}------------------------------------------------

V. Indications for Use

The 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™ TKA Platform PSI free and the predicate NextAR™ TKA Platform PSI based share the following characteristics:

principle of operation;
user interface;
power source;
surgical workflow:
main system components; except MyKnee NextAR Cutting Blocks;
use of surgical instruments for navigation;
orientation and positioning of bone resections; and
device accuracy.
use of active optical tracking system
computer hardware;
pre-operative patient anatomy data acquisition. ●

{6}------------------------------------------------

A Platform PSI free and the predicate NextAR™ TKA Platform PSI based are

registration of sensor position through dedicated algorithm, intra-operatively.

Discussion

There are minor differences between the subject and predicate devices; these differences are of sensors with respec d algorithm. They do not raise different questions of safety or effectiveness when compared to the predicate device. Both navigation systems utilize stereotaxic technologies within
the same surgical workflow. Minor differences are addressed by performing ca rational.

erformance Data VII.

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

software validation; ●
cadaver study. ●

The following studies were accepted during the submission of the predicate NextAR™ TK A Platform PSI based K193559 and they are unchar

biocompatibility per ISO 10993-1:2009;
sterilization validation; ●
shelf-life testing; ●
electrical safety testing per IEC 60601-1:2005, COR1:2006, COR2:2007, An ●
electromagnetic compatibility testing per IEC 60601-1-2 .
performance testing to evaluate mechanical and optical properties.

Conclusion VIII.

The information provided above supports that the NextAR™ TKA Platform Extension (PSI stantially equivalent to the identified predicate devices

tial equivalence has been demonstrated through a comparison of intended use, design and cal characteristics, as well as performance evaluations. The NextAR™ TKA Platform Extension (PSI free) 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).