The U2 Total Knee system 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 cannot be satisfactorily balanced and stabilized at the time of surgery.

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

Device Description

U2 Porous Coated Femoral Component-CR Type is manufactured from Co-Cr-Mo alloy confirming to ASTM F75. The inner surface is porous coated with Co-Cr-Mo beads (ASTM F75) to provide a porous surface for enhanced fixation. It is available in seven proportional sizes (#1~ #7, AP/ML ranging from 52mm to 76mm/ 80mm) and is provided in left and right configurations. The femoral component is the same as that of cleared U2 Total Knee System (K051640), except adding size #7.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "U2 Femoral Component, CR, Porous Coated." This is a premarket notification to demonstrate that the device is substantially equivalent to a predicate device, and it primarily focuses on non-clinical performance data.

Therefore, the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, expert qualifications, ground truth establishment methods, and MRMC studies is not applicable or not provided in this type of submission. These details are typically associated with studies evaluating the performance of AI/CADe devices, which this document is not.

The device in question is a physical orthopedic implant, not a software or AI-based diagnostic tool. The performance data presented refers to mechanical and design-based tests.

Here's a breakdown of why each point of your request cannot be fully answered based on the provided document:

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

Acceptance Criteria: Not explicitly stated as pass/fail thresholds against specific numerical values. The document states that "Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results demonstrated that this device is safe and effective." This implies all tests met their inherent safety and effectiveness requirements, but specific performance metrics and their acceptance benchmarks are not detailed.
Reported Device Performance: The document lists the types of non-clinical tests performed, but does not provide the results or specific performance metrics from these tests. It only states that the tests "demonstrated that this device is safe and effective."

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical thresholds	Specific numerical results are not provided in this summary. The tests were reported as demonstrating safety and effectiveness.

2. Sample sizes used for the test set and the data provenance

Sample Size: Not applicable. The tests performed are non-clinical (e.g., mechanical tests on the implant itself), not involving human or clinical data.
Data Provenance: Not applicable.

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

Number of experts and qualifications: Not applicable. There is no "ground truth" to be established by experts as this is not a diagnostic device involving interpretation of data.

4. Adjudication method for the test set

Adjudication method: Not applicable.

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

MRMC study: No, this device is an orthopedic implant, not an AI or diagnostic tool. Thus, no MRMC study was performed.

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

Standalone performance: No, this is not an algorithm or AI device.

7. The type of ground truth used

Type of ground truth: Not applicable. For devices like this, safety and effectiveness are confirmed through established engineering and materials testing standards (e.g., ASTM F75 for Co-Cr-Mo alloy).

8. The sample size for the training set

Training set sample size: Not applicable. This is not an AI/machine learning device that requires a training set.

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

Ground truth establishment for training set: Not applicable.

Summary of Relevant Information from the Document:

Device Type: U2 Femoral Component, CR, Porous Coated - a femoral component for total knee replacement, made from Co-Cr-Mo alloy and porous coated.
Purpose of Submission: Demonstrate substantial equivalence to predicate devices (K051640 and K030612) by showing similar materials, design, manufacturing, and intended use, and adding a new size (#7).
Performance Data: Non-clinical tests were conducted according to the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA."
Specific Tests Performed (Non-clinical):
- Range of Motion
- Contact Area and Contact Pressure on Femorotibial Joint
- Contact Area and Contact Pressure on Femoropatellar Joint
- Subluxation of Femorotibial Joint
- Fatigue Compression Test of Femoral Component
Clinical Performance Data: "None provided as a basis for substantial equivalence." This further confirms that no studies involving human subjects or clinical outcomes were part of this specific 510(k) submission.

This 510(k) focuses on mechanical and physical properties of an implant, rather than the diagnostic accuracy or performance of a digital health or AI-driven device.

Summary

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JUN 1 3 2014

0 U2 Femoral Component, CR, Porous Coated

510(k) Summary

510(k) Summary of Safety and Effectiveness

Submitter Information
Name	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
Name of Contact Person	Fang-Yuan Ho
	Regulation and Document Management
Date prepared	January 10, 2014
Name of Device
Trade Name	U2 Femoral Component, CR, Porous Coated
Common Name	Femoral Component
Classification Name and	Knee joint patellofemorotibial metal/polymer
Regulation	porous-coated uncemented prosthesis under 21CFR §888.3565
Device Class	Class II
Classification Panel	Orthopaedics
Product Code	MBH
Predicate Device	1. “United” U2 Total Knee System (K051640)2. “Smith & Nephew” Genesis II Total Knee System (K030612)

Device Description:

Page: 7-1/3

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U2 Femoral Component, CR, Porous Coated

cleared U2 Total Knee System (K051640), except adding size #7.

Intended Use:

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

Comparison to Predicate Device:

U2 Porous Coated Femoral Component-CR Type has the same materials, design, manufacturing and sterilization method as the femoral component of "United" U2 Total Knee System (K051640), except adding size #7. Besides, the basic design, size distribution, intended use of the subjected device and the method of fixation are similar with the femoral component of "Smith & Nephew" Genesis II Total Knee System (K030612).

Performance Data:

· Non-clinical Performance

This 510(k) submission was prepared in accordance with the Agency's. " Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and

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( U2 Femoral Component, CR, Porous Coated

510(k) Summary

Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA". Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results demonstrated that this device is safe and effective.

Range of Motion a.
· b. Contact Area and Contact Pressure on Femorotibial Joint
Contact Area and Contact Pressure on Femoropatellar Joint C.
d. Subluxation of Femoroltibial Joint
Fatigue Compression Test of Femoral Component e.
Clinical Performance Data/Information

None provided as a basis for substantial equivalence.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a human figure with outstretched arms, composed of three curved lines.

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

June 13, 2014

United Orthopedic Corporation Fang-Yuan Ho Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu 300 Taiwan

K140075 Re:

Trade/Device Name: U2 Femoral Component, CR, Porous Coated Regulation Number: 21 CFR 888.3565 Regulation Name: Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: MBH Dated: March 24, 2014 Received: March 25, 2014

Dear Fang-Yuan 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. 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 device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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 vours.

Lori A. Wiggins

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

Enclosure

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Indication for Use

510 (k) Number (if known): K140075

Device Name: U2 Femoral Component, CR, Porous Coated

Indications for Use:

For cemented femoral components, patellar components, tibial baseplate components and tibial inserts components: This device is a single use implant and intended for cemented use only.

For porous coated femoral component: This device is a single use implant and intended for cementless use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (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 Orthopedie Devices

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Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.