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 can be satisfactorily balanced and stabilized at the time of surgery. This device system is intended for cemented use only in the U.S.A.

Device Description

The Ultracongruent Insert is designed for the replacement of the bearing and/or articulating surfaces of the proximal tibia composed of an articulating bearing surface fixed in a metal tibial baseplate, and is used for patients with PCL incomplete, absent, nonfunctional or required release. It is used with the cruciate retained (CR) type Femoral Component. The anterior lip of Ultracruent Insert is more prominent when comparing with the U2 CR Insert (K051640, K103733), which increases the articulating surface area and expands the circumference to accommodate and stabilize the femur during knee flexion. The Ultracongruent Insert is available in seven proportional sizes (#1~ #7) and five thicknesses (thicknesses of insert + tibial baseplate: 9mm, 11mm, 15mm, and 18mm). The minimum thickness of Ultracongruent Insert is 6 mm on the bearing surface. It is manufactured from irradiated UHMWPE which conform to ASTM F2565, while the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834.

AI/ML Overview

The provided text describes a 510(k) summary for the "Ultracongruent Insert," a medical device. This document is a premarket notification for a new device claiming substantial equivalence to existing predicate devices. It does not contain information about a study that establishes acceptance criteria for performance metrics in the way you've outlined for AI/diagnostic devices (e.g., sensitivity, specificity, accuracy, expert consensus, MRMC studies).

Instead, this document details mechanical and material tests conducted to demonstrate the safety and effectiveness of the orthopedic implant. The "acceptance criteria" for such a device are typically related to meeting specific engineering standards and showing performance comparable to existing, legally marketed devices.

Here's an attempt to structure the information based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Study for the Ultracongruent Insert

This document describes a 510(k) premarket notification for a medical device called the "Ultracongruent Insert," a component of a total knee system. The "studies" conducted for this type of device are primarily engineering and material tests, not clinical or diagnostic performance studies involving human readers or AI.

1. Table of Acceptance Criteria and the Reported Device Performance

Performance Test	Acceptance Criteria (Implied)	Reported Device Performance
Constraint Test	Performance comparable to legally marketed predicate devices.	Conducted (implied acceptable outcome for 510(k) clearance).
Contact Area & Pressure	Performance comparable to legally marketed predicate devices.	Conducted (implied acceptable outcome for 510(k) clearance).
Range of Motion	Performance comparable to legally marketed predicate devices.	Conducted (implied acceptable outcome for 510(k) clearance).
Interlocking Strength Test	Performance comparable to legally marketed predicate devices.	Conducted (implied acceptable outcome for 510(k) clearance).
Materials	Conformity to ASTM F2565 (irradiated UHMWPE), ASTM F648, ISO 5834 (UHMWPE raw material).	UHMWPE conforms to ASTM F2565; raw material conforms to ASTM F648 and ISO 5834.

Note: For a 510(k) submission, "acceptance criteria" for these engineering tests are often that the device performs equivalently to the predicate device(s) or meets established industry standards for mechanical strength, wear, and biomechanical function. The document states that "the test results demonstrated that this device is safe and effective," implying these criteria were met.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state the sample sizes for the mechanical tests. For engineered medical devices, sample sizes are typically determined by engineering standards (e.g., minimum number of samples for fatigue testing, static strength testing).

Sample Size: Not specified in the provided text.
Data Provenance: The tests were "conducted to evaluate the safety and effectiveness of the subjected device." The location of these tests (e.g., in-house, third-party lab) and country of origin of the data are not specified, but the applicant company is located in Taiwan. These are retrospective tests conducted on device prototypes/samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This device is an orthopedic implant, not a diagnostic device requiring expert interpretation or ground truth establishment in a clinical sense. The "ground truth" for these tests relates to engineering specifications and performance benchmarks from predicate devices or industry standards.

4. Adjudication Method for the Test Set

Not applicable, as this is not a study involving human interpretation or clinical adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This document describes an orthopedic implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This concept is applicable to AI algorithms. This document describes a physical medical implant.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

Engineering Standards: Conformity to ASTM and ISO material standards.
Predicate Device Performance: Demonstrating comparable mechanical and material performance to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI algorithm or a diagnostic model for this type of device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. No training set or associated ground truth establishment process is relevant for this device.

Summary

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MAR 1 3 2014

( Ultracongruent Insert

510(k) Summary

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:	August 16, 2013
Contact Person	Fang-Yuan Ho
	Regulation and Document Management
Proprietary Name:	Ultracongruent Insert
Common Name:	Semi-constrained total knee prostheses
Device Classification	Knee joint patellofemorotibial polymer/metal/polymer
Name and Reference:	semi-constrained cemented prosthesis per 21CFR 888.3560.
	This 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. "United" U2 XPE Total Knee System (K103733)
	3. "Ortho Development" Balanced Knee System (K090705)
	4. "Biomet" Vanguard™ Complete Knee System (K050222)

Device Description:

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(9) Ultracongruent Insert

510(k) Summary

circumference to accommodate and stabilize the femur during knee flexion. The Ultracongruent Insert is available in seven proportional sizes (#1~ #7) and five thicknesses (thicknesses of insert + tibial baseplate: 9mm, 11mm, 15mm, and 18mm). The minimum thickness of Ultracongruent Insert is 6 mm on the bearing surface. It is manufactured from irradiated UHMWPE which conform to ASTM F2565, while the UHMWPE raw material is in accordance with ASTM F648 and ISO 5834.

Indications:

Basis for Substantial Equivalence:

The Ultracongruent Insert has the same indications, size distribution, materials and the same manufacturing and sterilization method as the XPE tibial insert of the "United" U2 Total Knee System. Besides, the basic design, prominent anterior lip height and intended use of the subjected device are similar with the tibial insert of "Ortho Development" Balanced Knee System® (K090705) and "Biomet" Vanguard"" Complete Knee System (K050222).

Performance Data:

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.

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( Ultracongruent Insert

510(k) Summary

Constraint Test a.
Contact Area and Contact Pressure b.
Range of Motion c.
d. Interlocking Strength Test

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 13, 2014

United Orthopedic Corporation Ms. Fang-Yuan Ho Regulatory Affairs Manager No. 57, Park Avenue 2, Science Park Hsinchu, 300 TAIWAN

Re: K132752

Trade/Device Name: Ultracongruent Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: January 28, 2014 Received: January 29, 2014

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. 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

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Page 2 - Ms. Fang-Yuan Ho

(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 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 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" (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/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometries/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 vours.

Ronald P. Jean -S 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

K132752 510 (k) Number (if known): _

Device Name: Ultracongruent Insert

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/5/Picture/7 description: The image shows the words "Casey L. Hanley, Ph.D." in bold black font. There is a black line underneath the name. Below the line, the words "Division of Orthopedic Devices" are written in bold black font.

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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.