The GMK(R) UNI knee prosthesis is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

Device Description

The GMK® UNI is a unicompartmental knee prosthesis. The GMK® UNI is comprised of individually packaged femur and tibial components designed for cemented use in partial knee arthroplasty if there is evidence of sufficient sound bone to seat and support the components. The femoral component is made of cobalt-chromium-molybdenum (Co-Cr-Mo per ISO 5832-4), and the tibial component consists of an ultra-high molecular weight polyethylene (UHMWPE per ISO 5834-2 Type 1) insert, and a metal-backed tray component (Co-Cr-Mo per ISO 5832-4). The GMK® UNI system implants are offered sterile (via gamma irradiation or ethylene oxide), are intended for single use only, and may not be re-sterilized.

The Anatomic Femoral Component (cemented) is anatomically shaped and designed with two (2) fixation pegs. Available in six (6) sizes (0 - 5), the femoral component is offered in both Right Medial/Left Lateral (RM-LL) and Left Medial/Right Lateral (LM-RL) options for each size.

The Fixed Tibial Insert has a fixed design and is available in five (5) sizes (1 – 5). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm).

The Fixed Plus Tibial Tray (cemented) has a fixed bearing design with one fixation keel and peg to ensure primary stability, and an UHMWPE plug. Available in five (5) sizes (1 – 5), the Fixed Plus Tibial Trays are offered in both Right Medial/Left Lateral (RM-LL) and Left Medial/Right Lateral (LM-RL) options for each size.

AI/ML Overview

This document primarily concerns the 510(k) premarket notification for a medical device, the GMK® UNI knee prosthesis. The core purpose of this document is to demonstrate "substantial equivalence" to legally marketed predicate devices, not to present a study proving the device meets acceptance criteria based on rigorous clinical performance benchmarks for an AI/ML device.

Therefore, I cannot extract the information you requested regarding acceptance criteria and study details in the context of an AI/ML device. The provided text describes the regulatory approval process for a medical implant (knee prosthesis) and focuses on its design, materials, and mechanical performance testing, which is very different from the evaluation of an AI/ML diagnostic tool.

The "Performance Testing" section lists:

Fatigue under dynamic physiological loads according to ASTM F1800
Excessive wear according to ASTM F2083
Sterilization validation in accordance with ANSI/AAMI/ISO 11137-1:2006, . ANSI/AAMI/ISO 11137-2:2006 and ISO 11135-1:2007
Accelerated and real time aging
Packaging validation

These are engineering and manufacturing quality tests for a physical implant, not performance metrics for an AI system. There is no mention of "human in the loop," "ground truth establishment," "expert consensus," "sample size for training/test sets," or "MRMC studies" because these concepts are not relevant to the approval of a joint prosthesis.

In summary, the provided document does not contain the type of AI/ML device performance study details you are asking for.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 14, 2017

Medacta International SA Stefano Baj Regulatory Affairs Manager Strada Regina 6874 Castel San Pietro (CH) Switzerland

Re: K161741 Trade/Device Name: GMK UNI Regulation Number: 21 CFR 888.3520 Regulation Name: Knee Joint Femorotibial Metal/Polymer Non-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: HSX Dated: March 13, 2017 Received: March 14, 2017

Dear Stefano Baj:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K161741

Device Name GMK(R) UNI

Indications for Use (Describe)

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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3 510(k) Summary

Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66
Stefano Baj Contact Person: Regulatory Affairs Manager Phone: +41 91 696 60 60 Fax: +41 91 696 60 66 Email: baj@medacta.ch
Date Prepared: June 17, 2016

DEVICE INFORMATION

Trade/Proprietary Name:	GMK® UNI
Common or Usual Name:	Unicompartmental Knee prosthesis
Classification Name:	Knee joint femorotibial metal/polymer/ non-constrained cementedprosthesis
Product Code:	HSX
Regulation Number:	21 CFR 888.3520
Device Class:	II

PREDICATE DEVICE INFORMATION

Primary predicates:

510(k)	Product	510(k) Holder
K073175	Journey	Smith & Nephew

Additional predicates:

510(k)	Product	510(k) Holder
K102069	Journey	Smith & Nephew
K033363	UNI	Zimmer

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DEVICE DESCRIPTION

The Fixed Tibial Insert has a fixed design and is available in five (5) sizes (1 – 5). Each size is offered in six (6) levels of thickness (8, 9, 10, 11, 12, 14 mm).

INDICATIONS FOR USE

The GMK® UNI knee prosthesis is designed for cemented use in partial knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. Partial replacement of the articulating surfaces of the knee is indicated when only one side of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

Discussion:

The Indications for Use Statement is similar to the predicate device. The only difference is that the subject device calls out the requirements for "evidence of sufficient sound bone to seat and support the components", and the predicate device cites specific example of degenerative joint disease ("osteoarthritis, traumatic arthritis, or avascular necrosis"). These differences do not create new intended uses for the subject device; the subject and predicate devices are all prostheses intended for use in knee arthroplasty.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

The design features, and materials of the subject devices are substantially equivalent to those of the predicate devices. The tables below compare characteristics of the subject and predicate devices.

Feature	GMK UNI - AnatomicFemoral Component(cemented)	Smith & NephewJourney(K073175)	Zimmer UNI(K033363)
Sizes	6 sizes (Size 0 - 5)	7 sizes (Size 1 -7)	7 sizes (Size A - G)
Configuration	RM-LL and LM-RL	Same	Same
Material	CoCrMo - ISO 5832-4	Same(with an oxinium oxidizedzirconium coating)	Same
Cemented?	Cemented	Same	Same
DeviceUsage	Single Use	Same	Same
Sterility	Provided sterile via GammaRadiation	Same	Same
Shelf Life	5 Years	Same	> 5 Years
Stabilizationpegs	Anatomic Femoralcomponent is cementedwith two (2) pegs.	Same	Same

Feature	GMK UNI - Fixed Tibial Insert	Zimmer UNI(K033363)
Sizes	5 sizes (from 1 to 5)	6 sizes (from 1 to 6)
Thickness	Each size is offered in 6 levels of thickness(8, 9, 10, 11, 12, 14 mm)	Same
Material	UHMWPE (ISO 5834 -2) Type 1	Same
DeviceUsage	Single Use	Same
Sterility	Provided sterile via Ethylene Oxide	Same
Shelf Life	5 years	> 5 years

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Feature	GMK UNI - Fixed PlusTibial Tray (cemented)	Smith & Nephew Journey(K102069)	Zimmer UNI(K033363)
Sizes	5 sizes (from 1 to 5)	6 sizes	6 sizes (from 1 to 6)
Configurations	RM-LL and LM-RL	Same	Same
Material	CoCrMo (ISO 5832-4)Plug: UHMWPE (ISO5834 -2) Type 1	Same	Ti-6Al-4V with PMMAprecoat
Cemented?	Cemented	Same	Same
Device Usage	Single Use	Same	Same
Sterility	Provided sterile viaGamma Radiation	Unknown	Same
Shelf Life	5 years	Unknown	> 5 years
Stabilization	Stabilized with peg andkeel	Same	Same
FixedBearing?	Fixed bearing	Same	Same

The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the subject devices is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

PERFORMANCE TESTING

The following studies were performed to support substantial equivalence:

Fatigue under dynamic physiological loads according to ASTM F1800 ●
Excessive wear according to ASTM F2083 ●
Sterilization validation in accordance with ANSI/AAMI/ISO 11137-1:2006, . ANSI/AAMI/ISO 11137-2:2006 and ISO 11135-1:2007
· Accelerated and real time aging
Packaging validation

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AWWWBased on the above information, the GMK® UNI can be considered substantially equivalent AWWW the identified predicate devices.

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.