The GMK HINGE® knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation require the implantation of a constrained prosthesis.

The GMK HINGE® knee system is indicated in the following cases:

Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, . rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability
Considerable loss of function of the knee joint .
High-grade joint destruction requiring additional stabilization with stems and . reconstruction of bone defects with metal augmentation
Failure of a primary prosthesis (e.g. infection, loosening) .
Former revision arthroplasty .
Post traumatic loss of joint configuration .
Avascular necrosis of femoral condyle .

Tibial augmentations are to be screwed to the tibial baseplate with both of the two provided fixing screws.

When a GMK HINGE® implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.

Device Description

The GMK Hinge System is a hinged-knee system for total knee replacement. The GMK Hinge femoral component is designed to preserve bone stock. The hinge-post system is comprised of the hinge post and the hinge post extension and has been developed in order to reduce the impingement with the patellar tendon and provide mechanical resistance. There is a UHMWPE bushing between the femoral component and the hinge post in order to avoid contact between metal parts. The tibial component has an asymmetric design to provide coverage of the bone after tibia resection. The surface is mirror polished and the holes for the tibial augmentations are on the bottom. The UHMWPE tibial insert is fixed to the tibial component through a screw and is designed to provide high rotational control and a high varus/valgus constraint. The femoral and tibial augments allow the surgeon to selectively fill bone deficiencies and to aid in restoring the ioint line. The fixation between the augmentations and the femoral component or tibial trav is assured by a screw fixation. The GMK Hinge provides two solutions for the patella prosthesis: an inset patella and a resurfacing patella. The GMK Hinge System would be used most often in patients with poor bone quality or marked bone loss, and in these circumstances, extension stems are helpful to obtain a stable construct. An extension stem in combination with the right offset connector provides intramedullary femoral and tibial fit and fill.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Medacta International SA GMK Hinge, a total knee prosthesis. It details the device's design, indications for use, comparison to predicate devices, and performance testing. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth, expert adjudication, or sample sizes related to AI/algorithm performance.

The document is a regulatory submission for a medical device (knee prosthesis), not an AI/ML-driven device, so the requested information about AI model performance is not applicable or present in this context. The "performance testing" section refers to mechanical testing of the physical implant against established medical device standards.

Therefore, most of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as "acceptance criteria" in terms of performance metrics. The text states the GMK Hinge "was tested according to the following standards: ISO 21534, ISO 7207-1, ASTM F1800, ASTM F2083-11, ASTM F1223-08." The acceptance criteria would be successful adherence to these standards, but the specific metrics are not detailed.
Reported Device Performance: The document states, "The comparison to predicate devices and the mechanical testing performed demonstrate that the GMK Hinge does not introduce any issues in regards to safety and effectiveness." No specific quantitative performance data is provided beyond this general statement of compliance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This refers to the testing of a physical device, not an algorithm. The "test set" would be the prototypes or representative samples of the knee prosthesis subjected to mechanical tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. Ground truth in this context would implicitly be successful mechanical performance as defined by the standards. No "experts" are mentioned for establishing this but rather accredited testing laboratories or engineers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is compliance with established mechanical testing standards (ISO and ASTM).

8. The sample size for the training set

Not applicable/Not provided. This is a physical device, not an AI model.

9. How the ground truth for the training set was established

Not applicable/Not provided.

Summary of available information from the text:

Device: GMK Hinge (Total Knee Prosthesis)
Applicant: Medacta International SA
Regulatory Status: 510(k) cleared as a Class II device (KRO product code).
Predicate Devices: K003504 (RT-Plus), K013385 (NexGen Rotating Hinge Knee), K002552 (Modular Rotating Hinge Knee), K101815 (Enduro RHK), K896048 (S-ROM/NOILES).
Performance Testing Standards: ISO 21534, ISO 7207-1, ASTM F1800, ASTM F2083-11, ASTM F1223-08.
Conclusion of Performance Testing: "The comparison to predicate devices and the mechanical testing performed demonstrate that the GMK Hinge does not introduce any issues in regards to safety and effectiveness."
Ground Truth (Implication): Compliance with the specified ISO and ASTM mechanical testing standards for knee prostheses.

Given the input document is for a physical medical device (a knee prosthesis) and not an AI/ML-driven device, most of the questions related to AI model performance, ground truth establishment, expert adjudication, and sample sizes for training/test sets are inapplicable.

Here's the information that can be extracted from the document, though it doesn't align with the AI/ML-focused questions:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with ISO 21534	Met standards
Compliance with ISO 7207-1	Met standards
Compliance with ASTM F1800	Met standards
Compliance with ASTM F2083-11	Met standards
Compliance with ASTM F1223-08	Met standards
Note: The document states that the mechanical testing performed demonstrates the GMK Hinge "does not introduce any issues in regards to safety and effectiveness" and is "substantially equivalent" to predicate devices based on these tests. Specific performance values are not provided in this summary.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for the mechanical tests. (This refers to physical prototypes of the device, not data for an algorithm.)
Data Provenance: Not applicable in the context of an AI/ML device. The "data" here would be the results from mechanical testing of the physical knee prosthesis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for this device is compliance with established engineering and material standards for knee prostheses. This would typically be assessed by accredited testing laboratories and engineers, not clinical experts establishing a "ground truth" diagnosis.

4. Adjudication method for the test set:

Not applicable. The assessment is against objective mechanical standards, not subjective interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI/ML device, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is not an AI/ML device.

7. The type of ground truth used:

Compliance with established international and American national mechanical testing standards for knee prostheses (ISO 21534, ISO 7207-1, ASTM F1800, ASTM F2083-11, ASTM F1223-08).

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model.

9. How the ground truth for the training set was established:

Not applicable. This is a physical device, not an AI model.

Conclusion: The provided text is a 510(k) summary for a traditional medical device (a knee prosthesis). It details the device's design, indications, materials, and compliance with mechanical testing standards to demonstrate substantial equivalence to predicate devices. It does not pertain to an AI/ML-driven device, and therefore, most of the requested information regarding AI model evaluation is not present.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two black triangles on the left, followed by the word "Medacta" in black lowercase letters. Below the word "Medacta" is a horizontal line, and below that is the word "International" in a smaller font, followed by a small cross symbol.

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

AUG 1 5 2013

Contact Person: Mr. Adam Gross Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com
Date Prepared: February 5, 2013

DEVICE INFORMATION

Trade/Proprietary Name: GMK Hinge Common Name: Total Knee Prosthesis Classification Name: Prosthesis Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

21 CFR 888.3510 Class II Device Product Code: KRO

Section 5 - Page 2 of 4

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

510(k)	Product	510(k) Holder	ClearanceDate
K003504	RT-Plus	Plus Orthopedics	5/11/2001
K013385	NexGen Rotating Hinge Knee	Zimmer	1/9/2002
K002552	Modular Rotating Hinge Knee	Stryker/Howmedica	11/13/2000
K101815	Enduro RHK	Aesculap	12/20/2010
K896048	S-ROM/NOILES	Depuy	03/14/1990

"Predicate Devices:

Product Description

Indications for Use

The GMK HINGE® knee system is indicated in the following cases:

Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, . rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability
Considerable loss of function of the knee joint .
High-grade joint destruction requiring additional stabilization with stems and . reconstruction of bone defects with metal augmentation
Failure of a primary prosthesis (e.g. infection, loosening) .
Former revision arthroplasty .

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

· Post traumatic loss of joint configuration
Avascular necrosis of femoral condyle

Tibial augmentations are to be screwed to the tibial baseplate with both of the two provided fixing screws.

When a GMK HINGE® implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.

Comparison to Predicate Devices

The indications for use, design features, and materials of the subject device are substantially equivalent to those of the predicate devices.

The design features of both the GMK Hinge and the predicates are a constrained, rotating knee prosthesis that have similar sizes and are intended to be used for cemented use only.

The GMK Hinge and the predicates use the same materials: CoCrMo (ISO 5832-4) UHMWPE (ISO 5834-2 Type 1) Ti6Al4V (ISO 5832-3) CoCrMo (ISO 5832-12) M30NW (ISO 5832-9)

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

Performance Testing

The GMK Hinge was compared to the worst case of the predicate devices. GMK Hinge was tested according to the following standards:

. ISO 21534
ISO 7207-1 .
ASTM F1800 .
ASTM F2083-11 .
ASTM F1223-08 .

The comparison to predicate devices and the mechanical testing performed demonstrate that the GMK Hinge does not introduce any issues in regards to safety and effectiveness.

Conclusion:

Based on the above information, the GMK Hinge can be considered as substantially equivalent to its predicate devices.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure embracing a globe, symbolizing the department's mission to protect and promote the health and well-being of the nation.

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

August 15, 2013

Medacta International SA % Medacta United States of America Mr. Adam Gross Director of Regulatory and Quality 4725 Calle Quetzal, Unit B Camarillo, California 93012

Re: K130299

Trade/Device Name: GMK Hinge Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: June 20, 2013 Received: June 21, 2013

Dear Mr. Gross:

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

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

Page 2 - Mr. Adam Gross

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Erin Keith

For

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

Enclosure

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

Indications for Use

K130299 510(k) Number (if known):

Device Name: GMK Hinge

Indications for Use:

The GMK HINGE® knee system is indicated in the following cases:

Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, . rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability
Considerable loss of function of the knee joint .
High-arade joint destruction requiring additional stabilization with stems and . reconstruction of bone defects with metal augmentation
Failure of a primary prosthesis (e.g. infection, loosening) .
Former revision arthroplasty .
Post traumatic loss of joint configuration .
Avascular necrosis of femoral condyle .

Tibial augmentations are to be screwed to the tibial baseplate with both of the two provided fixing screws.

When a GMK HINGE® implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.

Prescription Use X (21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey L. Hanley, Ph.D.
Division of Orthopedic Devices

GMK Hinge 510(k) February 5, 2013

Section 4 - Page 2 of 2

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.