Rheumatoid arthritis
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis
Failed osteotomies, unicompartmental replacement, or total knee replacement
Moderate varus, valgus, or flexion deformities
This device is indicated for cemented use only.

Device Description

OptiGen™ Total Knee System consists of femoral components(PS, CR), tibial components, tibial bearings(PS, CR), patellar components and accessories(locking bars, tibial cement plug). Components are available in a variety of designs and size ranges intended for primary application with bone cement. Implant components are made from materials meeting the requirements of various widely recognized standards including ISO, ASTM.

AI/ML Overview

I am unable to provide a description of the acceptance criteria and the study that proves the device meets them, based on the provided text. The document refers to the OptiGen™ Total Knee System and describes its materials, intended use, and claims substantial equivalence to predicate devices based on "bench testing." However, the text does not explicitly state the acceptance criteria for these tests, nor does it detail the specific numerical results or how these results "prove" that the device meets them.

The document only states that the testing "met all acceptance criteria and verifies that performance of the OptiGen™ Total Knee System is substantially equivalent to the predicate devices." It does not provide the specifics of these criteria or the test outcomes.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: The acceptance criteria and specific performance results are not provided.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document only mentions "non clinical setting (bench testing)." There's no information on sample size or data provenance.
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): This type of information is not relevant or included in the provided text for a bench testing study of a knee implant.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable and not mentioned for bench testing.
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, as this is a bench testing study for a physical device, not an AI-based diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For bench testing of a physical device, the "ground truth" would be the engineering specifications and performance metrics of established predicate devices, which are not detailed here.
The sample size for the training set: Not applicable, as this is bench testing, not an AI model.
How the ground truth for the training set was established: Not applicable.

Summary

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K102367
pg 1 of 3

DEC - 8 2010

Manufacturer:	U & I Corporation529-1, Yonghyun-dong, UijungbuKyunggi-Do, Korea 480-050Gyeong-Je Kwon, Regulatory Affairs Specialist
Sponsor:	U & I Corporation529-1, Yonghyun-dong, UijungbuKyunggi-Do, Korea 480-050
Sponsor Contact:	Gyeong-Je Kwon, Regulatory Affairs Specialist
Date Prepared:	August 19, 2010
Trade Name:	OptiGenTM Total Knee System
Common Name:	Total Knee System
Classification Name:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, per 21 CFR 888.3560
Product Code:	JWH
Predicate Devices:	Genesis II Total Knee System - K951987Maxim Knee System - K915132, K922285, K993159P.F.C Sigma Knee System - K884796, K892394, K935262NexGen CR-Flex, LPS-Flex System - K933785, K023211U2 Total Knee System - K021657MG II Porous Total Knee System - K892800

Description of Device:

510(k) Summary

OptiGen™ Total Knee System

Image /page/0/Picture/8 description: The image shows the logo for U & I Corporation. The logo is in black and white. The letters U and I are large and bolded, with the ampersand (&) in between them. The word "CORPORATION" is to the right of the letters, in a smaller, bolded font.

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K102367
pg 2 of 3

Materials

Femoral components Tibial Components Tibial Bearings Patellar Components Tibial Cement Plug Locking Bars

CoCrMo Alloy (ASTM F75) Titanium Alloy (ASTM F136) UHMWPE (ASTM F648) UHMWPE (ASTM F648) UHMWPE (ASTM F648) Titanium Alloy (ASTM F136)

Intended Use:

The OptiGen™ Total Knee System is indicated for patients with severe knee pain and disability due to:

Rheumatoid arthritis ●
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis ●
Failed osteotomies, unicompartmental replacement, or total knee ● replacement
Moderate varus, valgus, or flexion deformities .

This device is indicated for cemented use only.

Substantial Equivalence:

The OptiGen™ Total Knee System is substantially equivalent to Genesis II Total Knee System(K951987), Maxim Knee System(K915132, K922285, K993159), P.F.C Sigma Knee System(K884796, K892394, K935262), NexGen CR-Flex, LPS-Flex System(K933785, K023211), U2(K021657), MG II(K892800) in design, performance, function and intended use.

1. Comparison technological characteristics
  The Predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities:
The similar indications for use
Similar design features .
Incorporate the same or similar materials .
The equivalent mechanical performance ●

Image /page/1/Picture/19 description: The image shows the logo for U&I Corporation. The logo features a stylized "U&I" in bold, black font. To the right of the letters is the word "CORPORATION" in a smaller, sans-serif font, also in black.

OptiGen™ Total Knee System

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K102367
pg 30ff3

Performance Testing

The OptiGen™ Total Knee System was tested in a non clinical setting (bench testing) to assess that no new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the OptiGen™ Total Knee System is substantially equivalent to the predicate devices.

The following tests were performed: (1) Static test

A/P shear test ●
M/L shear test .
Tensile pull-off test .
Locking bar removal test .
A/P draw test .
M/L draw test .
I/E roration test ●
Patellofemoral subluxation test .
Tibial tray test .
Post shear test .
Femorotibial contact test
Patellofemoral contact test
(2) Dynamic test
- Tibial tray test .
- Post shear test .

3. Conclusion

The data and information provided in this submission support the conclusion that the OptiGen™ Total Knee System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.

U&J CORPORATION

OptiGen™ Total Knee System

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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 stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

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

U&I Corporation % Mr. Gyeong-Je Kwon Assistant Manager, Regulatory Affairs 529-1, Yonghyun-dong, Uijungbu Kyunggi-Do, Korea 480-050

DEC - 8 2010

Re: K102367

Trade/Device Name: OptiGen™ Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: November 19, 2010 Received: November 22, 2010

Dear Mr. Kwon:

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,

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Gyeong-Je Kwon

forth in the quality systems (QS) 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 go to http://www.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark H. Milliken

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

Enclosure

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K102367

Indications for Use Statement

DEC - 8 2010

510(k) Number (if known): __ K102367

Device Name: OptiGen™ Total Knee System

Indications for Use:

The OptiGen™ Total Knee System is indicated for patients with severe knee pain and disability due to:

Rheumatoid arthritis ●
Post-traumatic arthritis, osteoarthritis, or degenerative arthritis .
Failed osteotomies, unicompartmental replacement, or total knee . replacement
Moderate varus, valgus, or flexion deformities ●

This device is indicated for cemented use only.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Mettesson
Division Sign-Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102367

U&i CORPORATION

OptiGen™ Knee System

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.