The NextAR™ Knee 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™ Knee 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™ to view the same 2D stereotaxic information as presented by the NextARTM 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 MyKnee® PPS NextAR™ blocks include a PSI MyKnee® pin positioners block both for tibia and femur. The MyKnee® PPS NextAR™ blocks must be used as anatomical Pin positioners blocks 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 or MyKnee® PPS NextAR™ blocks are applicable only for the "PSIbased" approach. MyKnee® NextAR™ cutting guides or MyKnee® PPS NextAR™ blocks 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™ Knee stereotaxic instruments, when registered with the MyKnee® NextAR™ Knee cutting guides, provide reference to a patient's rigid anatomical structures, such as the femur and tibia, that can be identified relative to preoperative 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) an option;
MyKnee NextAR Pin Positioners (PPS) - an option; and
Reusable surgical instruments for total knee replacement 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 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. In NextAR TKA MyKnee PPS, subject of the submission, the placement of the sensor is performed by the use of reusable metal instrumentation used in the PSI free version (NextARTM TKA Platform, K202152).

The NextAR™ TKA Platform PSI based, PSI free and now NextAR™ TKA MyKnee PPS aid the surgeon in executing the surgical plan by visualizing all the information in real time in a screen monitor. Utilizing the approach NextAR™ TKA Platform PSI based (K193559) the placement of the implants is performed by cutting the bones using MyKnee® NextAR™ Cutting Blocks and, optionally, utilizing the approach NextAR™ TKA Platform PSI free (K202152), the placement of the implants is performed by cutting the bones using navigated reusable surgical instrumentation where the registration of the CT scan of the patient's anatomy is performed by executing the NextAR registration algorithm. Now, NextAR™ TKA MyKnee PPS fuses from both PSI and PSI free method. NextAR PPS helps the surgeon to place the metal fixation for the sensor and the pins to place the standard or micrometric cutting guides to reproduce the preoperative planning.

Same reusable surgical instrumentation (provided non-sterile) 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.

The MyKnee® NextAR™ Pin Positioners, manufactured from medical grade nylon, are single use patient-specific blocks which are designed from patient CT images. They are intended to position the pins for placement of the standard instruments and for the infrared technology. The blocks are provided sterile via gamma irradiation or non-sterile.

The surgeon can choose the desired approach, PSI-based (clearance - K193559), PSI-free (clearance - K202152), or PPS now under submission.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information for the NextAR™ TKA Platform My Knee PPS device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
- Device accuracy for orientation and positioning of bone resections. - Software validation. - In vitro validation. - Biocompatibility (per ISO 10993-1:2009). - Sterilization validation. - Shelf-life testing. - Electrical safety (per IEC 60601-1:2005, COR1:2006, COR2:2007, Amd1:2012). - Electromagnetic compatibility (per IEC 60601-1-2:2014). - Mechanical and optical properties performance.	- Device Accuracy: The device has similar characteristics to its predicate devices, which also include orientation and positioning of bone resections. The "in vitro validation" likely addressed this, confirming its performance is comparable. - Software Validation: Performed. - In Vitro Validation: Performed. - Biocompatibility: Accepted during predicate submissions (K193559 and K202152) and deemed unchanged. - Sterilization Validation: Accepted during predicate submissions and deemed unchanged. - Shelf-Life Testing: Accepted during predicate submissions and deemed unchanged. - Electrical Safety: Accepted during predicate submissions and deemed unchanged. - Electromagnetic Compatibility: Accepted during predicate submissions and deemed unchanged. - Mechanical and Optical Properties Performance: Accepted during predicate submissions and deemed unchanged.

Acceptance Criteria

Reported Device Performance

- Device accuracy for orientation and positioning of bone resections. - Software validation. - In vitro validation. - Biocompatibility (per ISO 10993-1:2009). - Sterilization validation. - Shelf-life testing. - Electrical safety (per IEC 60601-1:2005, COR1:2006, COR2:2007, Amd1:2012). - Electromagnetic compatibility (per IEC 60601-1-2:2014). - Mechanical and optical properties performance.

- Device Accuracy: The device has similar characteristics to its predicate devices, which also include orientation and positioning of bone resections. The "in vitro validation" likely addressed this, confirming its performance is comparable. - Software Validation: Performed. - In Vitro Validation: Performed. - Biocompatibility: Accepted during predicate submissions (K193559 and K202152) and deemed unchanged. - Sterilization Validation: Accepted during predicate submissions and deemed unchanged. - Shelf-Life Testing: Accepted during predicate submissions and deemed unchanged. - Electrical Safety: Accepted during predicate submissions and deemed unchanged. - Electromagnetic Compatibility: Accepted during predicate submissions and deemed unchanged. - Mechanical and Optical Properties Performance: Accepted during predicate submissions and deemed unchanged.

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

The document does not specify the exact sample size used for the test set (e.g., number of patients, number of anatomical models). It only mentions that "in vitro validation" was performed.

Data provenance is not explicitly stated in terms of country of origin. The studies are described as "in vitro validation," suggesting lab-based testing rather than studies involving human patients. Therefore, it's likely retrospective or prospective testing on inanimate objects/models, not patient data in the typical sense.

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

This information is not provided in the document. The studies listed are primarily technical validations (software, in vitro, safety, etc.), which may not inherently require expert human review to establish ground truth in the same way clinical diagnostic studies might.

4. Adjudication Method for the Test Set:

This information is not provided in the document. It's improbable that an adjudication method (like 2+1 or 3+1) was used, as the listed studies are technical validation tests rather than diagnostic performance studies requiring human interpretation of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned or described in the provided text. The device is a surgical navigation platform, not a diagnostic imaging AI tool in the typical sense of MRMC studies.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, a standalone performance study (algorithm only) was implicitly done through the "software validation" and "in vitro validation" studies. These types of studies typically evaluate the technical performance of the device/algorithm itself, independently of a human operator, to ensure its accuracy and functionality.

7. The Type of Ground Truth Used:

The document doesn't explicitly state the "type of ground truth" in a singular specific manner. However, for the technical validations:

Software Validation: Ground truth would be defined by the expected behavior and calculations of the software as per its design specifications.
In Vitro Validation: Ground truth would be established by precise measurements taken from physical models or phantoms using highly accurate reference instruments, against which the device's measurements/guidance are compared.
Device Accuracy (Orientation and Positioning): For this aspect, the ground truth would be extremely precise, independently verified knowledge of the true orientation and position of relevant anatomical structures or measuring points, against which the NextAR™ system's reported values are compared. This is usually achieved with high-precision metrology equipment in a lab setting.

8. The Sample Size for the Training Set:

The document does not provide any information on the sample size for a training set. This device is a navigation system that uses pre-operative CT data for planning. While it might involve algorithms that were developed using training data (e.g., for image segmentation or registration), the provided 510(k) summary does not disclose details about such training sets.

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

As no training set information is provided, how its ground truth was established is also not described in the document.

Summary

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March 10, 2022

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

Re: K213751

Trade/Device Name: NextAR™ TKA Platform Mv Knee PPS Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO. JWH, PBF Dated: December 17, 2021 Received: December 20, 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) K213751

Device Name NextARTM TKA Platform My Knee PPS

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: November 29, 2021 Date Revised: February 23, 2022

Device II.

Device Proprietary Name:	NextARTM TKA Platform My Knee PPS
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
	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 TKA Platform, K202152 .
NextARTM TKA Platform, K193559 ●

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Additional predicate device:

MyKnee® NextAR™ Cutting Blocks, K193559, Medacta International SA ●
. MyKnee® Pin Positioners, K170106, Medacta International SA

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) an option; ●
MyKnee NextAR Pin Positioners (PPS) - an option; and
Reusable surgical instruments for total knee replacement procedures. ●

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

NextAR™ TKA Platform PSI free is available on the US market via the clearance - K202152.

Same reusable surgical instrumentation (provided non-sterile) guided by the tracking sensors can be used also for recut. Although the position of the implants can be validated to assess the correct

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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™ Pin Positioners, manufactured from medical grade nylon, are single use
patient-specific blocks which are designed from patient CT images. They are intended to position
the pins for placement of the standard instruments and for the infrared technology. The blocks are
provided sterile via gamma irradiation or non-sterile.

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

K202152), or PPS now under submission.

ications for Use
RTM Knee Platform is intended to

e are inform pornoting and general singles in manufact is unplant the CMA on the West Market Ma
Hearter bound display, the summents of the Mark Mark Mark Marka Marka Walla
Martin to view and sec

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

ee® NextAR™ cutting guides include a camera/target holder and a PSI MyK
. for tibia and femur. The MyKnee® cutting guides must be used as anaton

க்கல் குறிக்கும் பயன்படுகின்றன. இந்த குறிக்கும் காண்டிகள் வாழ்க்குறி
கள் புகழ்கள் காண்டும் காண்டிகள் வாக்கிய காண்டிகளை மாவட்டத்தில்
கள் பகுதியாக வாக்கிய மாவட்டத்தில் காண்டிக

The use of MyKnee® NextART™ cutting guides or MyKnee® PPS NextART™ blocks are applicable
only for the “PSI-based” approach. MyKnee® NextART™ cutting guides or MyKnee® PPS
NextART™ blocks are for single use only.

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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 NextARTM Knee stereotaxic instruments, when registered with the MyKnee® NextAR™ Knee 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.

Comparison of Technological Characteristics VI.

The NextAR™ TKA MyKnee PPS and the predicate NextAR™ TKA Platform PSI Free share the following characteristics:

principle of operation; ●
user interface; ●
power source;
surgical workflow;
main system components; with 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; and
pre-operative patient anatomy data acquisition.

The NextARTM TKA Platform PPS and the predicate NextAR™ TKA Platform PSI free are technologically different with respect to:

registration of sensor position through updated algorithm, intra-operatively. ●
use of MyKnee NextAR Pin Positioners. ●

The MyKnee® NextAR™ Pin Positioner and the predicate devices (MyKnee® NextAR™ Cutting Blocks and MyKnee® Pin Positioners) share the following characteristics:

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

Only for the Tibial MyKnee® NextAR™ Pin Positioners and the predicate device MyKnee NextAR Cutting Blocks there is a technologically difference with respect to the number of contact point positions only for the Tibial pin positioner that are shared with the predicate device MyKnee® Pin Positioners.

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Discussion

There are minor differences between the subject and predicate devices; these differences are concerning the registration of the position of sensors with respect to the bones through the use of an updated algorithm and the use of MyKnee NextAR Pin Positioner.

They do not raise different questions of safety or effectiveness when compared to the predicate devices. Both navigation systems utilize stereotaxic technologies within the same surgical workflow. Minor differences are addressed by performing in vitro validation/rational.

VII. Performance Data

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

software validation;
in vitro validation

The following studies were accepted during the submission of the predicate NextAR™ TKA Platform PSI based K193559 and PSI free K202152 and they are unchanged.

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. ●

VIII. Conclusion

The information provided above supports that the NextAR™ TKA MyKnee PPS 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 MyKnee PPS 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).