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 behavior, instrument and implant positioning.

The NextAR™ TKA Platform is intended to be used in combination with NextARTM stereotaxic instruments, the MyKnee® NextAR™ cutting guides, 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. MyKnee® NextAR TKA cutting guides are for single use only.

The NextAR™ stereotaxic instruments are intended to be used to 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; and
reusable surgical instruments for total knee replacement procedures.

The system operates on the common principle of stereotaxic technology in which passive markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the markers to avoid intraoperative registration of bony landmarks. 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 aids the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor. The placement of the implants is performed by cutting the bones using MyKnee® NextAR™ Cutting Blocks while reusable surgical instrumentation (provided non-sterile) guided by the tracking sensors can be used 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.

The MyKnee® NextAR™ Cutting Blocks, manufactured from medical grade nylon, are single use patient-specific blocks which are designed from patient MRI or CT images. The blocks are designed to be used in standard medial or lateral parapatellar surgical approaches with each set comprised of a femoral block, a tibial block, and two bone models of the patient's femur and tibia (optional). The femoral cutting blocks are provided in right and left configurations in sizes 1 to 7 and 1+ to 6+ and the tibial cutting blocks are provided in right and left configurations in sizes 1 to 6. The blocks are provided sterile via gamma irradiation or non-sterile.

AI/ML Overview

The FDA 510(k) summary for the NextAR™ TKA Platform (K193559) provides details on the device's acceptance criteria and the studies conducted to prove its performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a single, consolidated format. However, it mentions various types of testing and states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." The "Discussion" section also states, "Minor differences in the optical tracking systems and use of patient specific instrumentation are addressed by performance testing." This implies that the performance testing confirmed the device met established criteria for those specific aspects.

Based on the information provided, we can infer some of the areas where acceptance criteria would have been applied:

Acceptance Criteria Area	Reported Device Performance (as inferred from the document)
Software Validation	Confirmed the software performed as intended and met its specifications.
Biocompatibility (ISO 10993-1:2009)	Confirmed the materials in contact with the patient were biocompatible.
Sterilization Validation	Confirmed the sterilization method (gamma irradiation for some components) effectively sterilized the device components.
Shelf-life Testing	Demonstrated the device components (e.g., MyKnee NextAR Cutting Blocks) maintained their integrity and sterility over their specified shelf life.
Electrical Safety (IEC 60601-1)	Confirmed the device met electrical safety standards.
Electromagnetic Compatibility (IEC 60601-1-2)	Confirmed the device operated without significant electromagnetic interference and was not adversely affected by it.
Mechanical and Optical Properties	Confirmed the mechanical integrity and optical performance of components, likely including accuracy of the optical tracking system and cutting blocks.
Accuracy (e.g., bone resections, implant positioning)	The document explicitly states device accuracy for both the NextAR™ TKA Platform and its predicate is a shared characteristic. It also states "Minor differences in the optical tracking systems and use of patient specific instrumentation are addressed by performance testing." This implies that the accuracy of the system in guiding bone resections and implant positioning (a core function of the device) was evaluated and met acceptable levels through a cadaver study. The exact numerical acceptance criteria for accuracy are not provided in this summary.

2. Sample Size for Test Set and Data Provenance

The document explicitly mentions a "cadaver study" as part of the performance data.

Sample Size for the Test Set: Not explicitly stated in the provided text.
Data Provenance: The cadaver study would involve human remains, but the exact country of origin or whether it was retrospective/prospective in the context of data collection for this specific study is not detailed. However, cadaver studies are inherently prospective for the purpose of testing the device.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly mention the number of experts, their qualifications, or their role in establishing ground truth specifically for the reported studies (e.g., cadaver study). For a device like this, ground truth would likely be established through precise anatomical measurements or post-hoc imaging.

4. Adjudication Method for the Test Set

The document does not detail any adjudication method (e.g., 2+1, 3+1) for the test set. Adjudication methods are typically associated with human interpretation of medical images or data, which is not the primary focus for establishing the technical accuracy of a navigation system in a cadaver study.

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

No mention of an MRMC comparative effectiveness study, or the effect size of human readers improving with AI vs. without AI assistance, is made. This device is a surgical navigation platform, not an AI-assisted diagnostic tool that heavily relies on human reader interpretation of images. The smart glasses are described as an auxiliary display, not an AI-driven interpretive aid for human readers.

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

The performance testing, particularly the "performance testing to evaluate mechanical and optical properties" and elements of the "cadaver study," would inherently involve evaluating the standalone performance of the algorithm and system components. The software validates the navigation software's ability to display information to the surgeon accurately. The cadaver study would assess how accurately the system guides the surgeon, implying that the system's output (measurements, guidance) is evaluated independently of a human's ultimate judgment during the assessment phase of the study, though a human surgeon performs the actions based on the guidance.

7. Type of Ground Truth Used

For the specific performance testing of this surgical navigation platform, especially in the cadaver study, the ground truth would likely be established using precise direct physical measurements (e.g., with highly accurate measurement tools or CMMs) or potentially post-operative imaging with precise measurements of the cadaver bones to verify the accuracy of resections and implant positioning as guided by the system. The "pre-operative CT based planning" is used by the device, and the device ensures "reference to a patient's rigid anatomical structures... that can be identified relative to pre-operative CT based planning." Therefore, the ground truth would be tied back to the anatomical accuracy relative to these plans.

8. Sample Size for the Training Set

The document does not provide information about a specific "training set" sample size. This type of device relies on established biomechanical principles and image processing of CT scans for its planning and navigation, rather than a deep learning model that requires a discrete training set in the conventional sense. The software is validated, but not "trained" in an iterative machine learning fashion on a large dataset of patient outcomes.

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

As no specific training set for a machine learning model is mentioned, the method for establishing its ground truth is not applicable or detailed in this summary. The system's foundational data (e.g., anatomical models, instrument specifications) are established through engineering design, scientific principles, and preclinical testing.

Summary

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July 10, 2020

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

Re: K193559

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 10, 2020 Received: July 10, 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

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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,

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) K193559

Device Name NextAR™ TKA Platform

Indications for Use (Describe)

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 MyKne® 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. MyKnee® NextAR TKA cutting guides are for single use only.

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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K193559

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 Manager, Medacta International SA Applicant Correspondent: Christopher Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: December 20, 2019 Date Revised: July 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.
Primary Product Code:	OLO
Secondary Product Codes:	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:

iMNS Medacta Navigation System, K083872 and K100314, Medacta International SA ●
Additional predicate device:
MyKnee Cutting Blocks, K093806, Medacta International SA ●
. Xvision Spine System, K190929, Augmedics Ltd.

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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; and ●
reusable surgical instruments for total knee replacement procedures. ●

V. Indications for Use

"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 behavior, instrument and implant positioning.

The NextAR™ TKA Platform is intended to be used in combination with NextAR™ stereotaxic instruments, the MyKnee® NextAR™ cutting guides, and general surgical instruments to implant the GMK Sphere Total knee system and perform ligament balancing. As an optional display, the

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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 NextARTM 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."

VI. Comparison of Technological Characteristics

The NextAR™ TKA Platform and the predicate device (iMNS Medacta Navigation System) 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. ●

The NextAR™ TKA Platform and the predicate device (iMNS Medacta Navigation System) are technologically different with respect to:

use of active vs. passive optical tracking system; ●
. registration of anatomy through patient specific instrumentation;
computer hardware;
use of MyKnee NextAR Cutting Blocks; and ●
pre-operative vs. intraoperative data acquisition. ●

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The MyKnee® NextAR™ Cutting Blocks and the predicate device (MyKnee Cutting Blocks) share the following characteristics:

material of construction; ●
manufacturing process; ●
. size and dimensions;
sterilization method; and ●
. packaging.

The MyKnee® NextAR™ Cutting Blocks and the predicate device (MyKnee Cutting Blocks) are technologically different with respect to the number of contact point positions.

Discussion

There are minor differences between the subject and predicate devices; however, these differences 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 in the optical tracking systems and use of patient specific instrumentation are addressed by performance 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;
biocompatibility per ISO 10993-1:2009; ●
. sterilization validation;
. shelf-life testing;
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; and
cadaver study.

VIII. Conclusion

The information provided above supports that the NextAR™ TKA 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™ TKA Platform can be considered substantially equivalent to the identified predicate devices.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.