This device is indicated in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery.

This device is intended for cemented use only.

Device Description

This device is an additional size extension to the previously cleared "UNITED" U2 Total Knee System (K051640). The materials; design, safety and effectiveness of this subject is identical to the previously cleared femoral components - PS type of "UNITED" U2 Total Knee System (available in sizes #1~#6 ranging from 52mm/ 56mm AP-ML to 72mm/ 76mm A/P-M/L), except for its larger size (76mm/80mm A/P-M/L). This device machined from cast Co-Cr-Mo alloy conforming to ASTM F75 are available in left and right configurations. Fixation of the femoral component to the femur is achieved using bone cement. This device is intended to be used with the previously cleared U2 PS tibial insert (K051640), U2 XPE tibial inserts - PS type (K112463), U2 tibial baseplate (K051640), U2 Patella components (K051640, K082469) and U2 XPE Patella components (K112463) in anv size. The size extending of femoral component does not affect the intended use of the device or alter the fundamental scientific technology of the device.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device, the U2 Femoral Component, PS, #7, which is an additional size extension to an existing knee prosthesis.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance data presented are qualitative statements indicating that tests were completed and demonstrated safety and effectiveness.

Performance Metric	Acceptance Criteria (Not explicitly stated numerically)	Reported Device Performance
Range of motion	Implied: Equivalent to predicate device K051640	Analysis completed; demonstrated device is safe and effective
Fatigue Test	Implied: Equivalent to predicate device K051640	Test completed; demonstrated device is safe and effective
Subluxation of femorotibial joint	Implied: Equivalent to predicate device K051640	Evaluation completed; demonstrated device is safe and effective
Contact area (femoropatellar/femorotibial)	Implied: Equivalent to predicate device K051640	Analysis completed; demonstrated device is safe and effective
Contact pressure (femoropatellar/femorotibial)	Implied: Equivalent to predicate device K051640	Analysis completed; demonstrated device is safe and effective
Femoral component fatigue fracture	Implied: Equivalent to predicate device K051640	Evaluation completed; demonstrated device is safe and effective

The study that "proves the device meets the acceptance criteria" is described as the completion of these performance tests as "part of the design assurance process." The conclusion derived is that the device is "substantially equivalent to the predicate device."

Additional Requested Information:

Since this document is a 510(k) summary for a medical device (a knee prosthesis component), the requested information typically relates to AI/software performance studies. This document does not describe an AI or software-based device, but rather a physical implant. Therefore, many of the questions regarding AI-specific study details (such as sample size for test/training sets, experts for ground truth, MRMC studies) are not applicable in this context.

However, I will address what can be inferred from the provided text in relation to these points:

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

Not applicable for AI/software. For the physical device, mechanical and material tests were performed. The "test set" would refer to the number of components tested for each performance metric (e.g., how many components underwent fatigue testing). This detail is not provided in the summary.
Data provenance: The testing was part of the "design assurance process" presumably conducted by the manufacturer, United Orthopedic Corporation, based in Hsinchu, Taiwan.

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

Not applicable for AI/software. For a physical implant, ground truth is established through engineering and biomechanical principles and standardized testing methods (e.g., ASTM F75 for Co-Cr-Mo alloy). Expert consensus in the traditional sense of clinical imaging interpretation is not relevant here.

4. Adjudication method for the test set:

Not applicable for AI/software. For mechanical testing, adjudication would involve interpreting test results against engineering specifications or established standards, rather than clinical consensus.

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 device is a physical knee implant, not an AI or software diagnostic tool. No human reader study with or without AI assistance would be relevant for demonstrating its performance.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used:

For mechanical and material properties, the ground truth is based on engineering standards, biomechanical principles, and performance characteristics established for predicate devices. For example, the Co-Cr-Mo alloy conforms to ASTM F75.

8. The sample size for the training set:

Not applicable. This device is a physical knee implant, not an AI/ML algorithm requiring a training set.

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

Not applicable. (See point 8)

Summary

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MAY - 4 2012

(GU2 Femoral Component, PS, #7: Special 510 (K)

510(k) Summary

K12 0507 (1)3

510(k) Summary of Safety and Effectiveness

Submitted by:	United Orthopedic Corporation
Address:	No 57, Park Ave 2, Science Park, Hsinchu 300, Taiwan
Phone Number:	+886-3-5773351 ext. 2212
Fax Number:	+886-3-577156
Date of Summary:	February 17, 2012
Contact Person	Fang-Yuan HoRegulation and Document Management
Proprietary Name:	U2 Femoral Component, PS, #7
Common Name:	Knee Prosthesis
Device Classification	Knee joint patellofemorotibial polymer/metal/polymer
Name and Reference:	semi-constrained cemented prosthesis under 21CFR 888.3560This falls under the Orthopedics panel.
Device Class	Class II
Panel Code	Orthopaedics Device
Device Product Code:	JWH
Predicate Device:	1. "UNITED" U2 Total Knee System (K051640)2. "Wright Medical Technology" Advance® Total Knee System (K972626)

" Smith & Nephew" Genesis II Knee System (K951987)

Device Description:

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

(U2 Femoral Component, PS, #7: Special 510 (K)

510(k) Summary

56mm AP-ML to 72mm/ 76mm A/P-M/L), except for its larger size (76mm/80mm A/P-M/L). This device machined from cast Co-Cr-Mo alloy conforming to ASTM F75 are available in left and right configurations. Fixation of the femoral component to the femur is achieved using bone cement. This device is intended to be used with the previously cleared U2 PS tibial insert (K051640), U2 XPE tibial inserts - PS type (K112463), U2 tibial baseplate (K051640), U2 Patella components (K051640, K082469) and U2 XPE Patella components (K112463) in anv size. The size extending of femoral component does not affect the intended use of the device or alter the fundamental scientific technology of the device.

Intended Use

This device is intended for cemented use only.

Basis for Substantial Equivalence:

The safety and effectiveness of the subject device are substantially equivalent to the previously cleared U2 Total Knee System (K051640), except for an extension in the size distribution. The modifications do not change the intended use or fundamental In addition, the subject device is also substantial equivalence to scientific technology.

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ம் U2 Femoral Component, PS, #7: Special 510 (K) 510(k) Summary

the PS femoral components of "Wright Medical Technology" Advance® Total Knee System (K972626) and "Smith & Nephew" Genesis II Knee System (K951987).

Performance Data:

Range of motion analysis, fatigue test, subluxation of femorotibial joint evaluation, contact area and contact pressure analysis on femoropatellar and femorotibial joints and femoral component fatigue fracture evaluation, completed as part of the design assurance process, demonstrated that this device is safe and effective and is substantially equivalent to the predicate device.

K120507 (3/3

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

United Orthopedic Corporation % Ms. Fang-Yuan Ho No. 57. Park Avenue 2. Science Park Hsinchu, Taiwan 300

MAY - 4 2012

Re: K120507

Trade/Device Name: U2 Femoral Component, PS, #7 Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained · cemented prothesis Regulatory Class: Class II

Product Code: JWH Dated: April 6, 2012 Received: April 9, 2012

Dear Ms. Ho:

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

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

Page 2 – Ms. Fang-Yuan Ho

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.fda.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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

cerely yours,

For

rk N. Melkerson

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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Indication for Use

K120507 510 (k) Number (if known):_

Device Name: U2 Femoral Component, PS, #7

Indications for Use:

This device is intended for cemented use only

Prescription Use _________x (Part 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)

Adises

K120507

Page 一 of

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

510(k) Number

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.