This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement. This device may be used for the following conditions:

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli and painful hip dysplasia.
Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
1. Correction of function deformity.
1. Revision procedures where other treatments or devices have failed.
Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Description

U2 Bipolar Implant is intraoperatively assembled to any appropriately size UNITED femoral stem with compatible head size. This device is offered in 38-56 mm outer diameters and with 22mm, 26mm and 28mm inner diameter. It is comprised of an outer shell (ASTM F75-12/ ISO 5832-4:2014 casting Co-Cr-Mo allov, raw materials ASTM F1537-11/ISO 5832-12:2007) into a permanently assembled bearing insert (ASTM F648-14/ISO 5834-1:2005 and ISO 5834-2:2011). The minimum thickness of the polyethylene at the load bearing area is 5 mm. The assembled prosthesis provides for primary articulation at the femoral head/inner polyethylene bearing interface and secondary articulation at the outer shell/acetabulum interface. The internal aspect of the shell is designed to lock the polyethylene liner. The outer metal surface of the bipolar hip prosthesis is highly polished for articulation with the patient's acetabulum.

Femoral head for size 22mm is designed for use with U2 Bipolar Implant. It is made of Co-Cr-Mo alloy (ASTM F1537-11). The material and process method of 22 mm femoral head are identical to the previous cleared "United" femoral head (K994078).

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the "U2 Bipolar Implant and 22mm Femoral Head." This particular type of document from the FDA is a regulatory submission for medical devices that are substantially equivalent to legally marketed predicate devices, and it generally does not include detailed clinical study reports or acceptance criteria/performance results in the same format as a novel device approval.

Based on the content, here's an analysis of what can and cannot be answered regarding acceptance criteria and device study:

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

The document does not provide a table of acceptance criteria with corresponding device performance values. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo acceptance criteria and then proving the device meets them through clinical or extensive non-clinical studies for novel products.

The "Performance Data" section lists non-clinical tests performed:

a. Locking Mechanism of U2 Bipolar Implant
b. Range of Motion of U2 Bipolar Implant
c. Disassembly Force for Femoral Head and Stem

However, specific acceptance criteria for these tests (e.g., minimum disassembly force in Newtons, minimum range of motion in degrees) and the numerical results of these tests are not provided in this document extract. The document simply states that these tests were "conducted to evaluate the safety and effectiveness of the subjected device."

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

This information is not provided. The document mentions non-clinical performance tests but does not detail the sample sizes used for these mechanical tests or the provenance of any data beyond indicating "Taiwan" as the submitter's location.

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)

This information is not applicable/provided. Since the document refers to non-clinical (mechanical) tests and no clinical data, there is no mention of experts establishing a ground truth as would be relevant for diagnostic imaging or similar devices.

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

This information is not applicable/provided. Adjudication methods are typically associated with human-read clinical studies, which are not detailed here.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices, which is not the nature of this hip implant.

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

This information is not applicable/provided. This device is a passive hip implant, not an algorithm.

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

For the non-clinical tests, the "ground truth" would be the engineering specifications and performance expectations derived from predicate devices and relevant ISO/ASTM standards. However, the specific "type of ground truth" (e.g., a specific standard section referencing a required force or range) is not explicitly stated in this document. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission, as no clinical studies are presented.

8. The sample size for the training set

This information is not applicable/provided. This device is a mechanical implant, not an AI/algorithm-based device that would require training data.

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

This information is not applicable/provided for the same reason as point 8.

Summary of what is known from the document regarding acceptance criteria and study:

Device Type: U2 Bipolar Implant and 22mm Femoral Head (hip joint femoral prosthesis).
Submission Type: 510(k) Premarket Notification based on substantial equivalence to predicate devices.
Study Focus: Primarily non-clinical performance tests.
Non-clinical Tests Conducted:
- Locking Mechanism of U2 Bipolar Implant
- Range of Motion of U2 Bipolar Implant
- Disassembly Force for Femoral Head and Stem
Clinical Performance Data: "None provided as a basis for substantial equivalence."
Acceptance Criteria & Performance Values: Not explicitly detailed in the document. The statement "the performance evaluation for stopper ring of subject device was also conducted" implies successful evaluation without providing specific results or criteria.
Sample Sizes / Provenance / Ground Truth for Experts: Not provided or not applicable given the nature of the device and submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.

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

April 7, 2016

United Orthopedic Corporation Ms. Karen Ho Regulatory Affairs Manager Number 57, Park Avenue 2, Science Park Hsinchu 300 TAIWAN

Re: K152439 Trade/Device Name: U2 Bipolar Implant and 22mm Femoral Head Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWY Dated: March 8, 2016 Received: March 11, 2016

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 (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (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 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 yours,

Mark N. Melkerson -S

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

K152439 510 (k) Number (if known):

Device Name: U2 Bipolar Implant and 22mm Femoral Head

Indications for Use:

This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement. This device may be used for the following conditions:

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli and painful hip dysplasia.
Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
1. Correction of function deformity.
1. Revision procedures where other treatments or devices have failed.
న. Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Prescription Use _ x x _ Over-The-Counter Use ___ AND/OR (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)

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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	Karen Ho
	Regulation and Document Management
Date prepared	August 21, 2015
Name of Device
Trade Name	U2 Bipolar Implant and 22 mm Femoral Head
Common Name	Bipolar Implant and Femoral Head
Classification Name and	The device classification for U2 Bipolar Implant and 22 mm
Regulation	Femoral Head is "Hip Joint femoral (Hemi-Hip)
	Metal/Polymer Cemented or Uncemented Prosthesis " and is
	contained in the Code of Federal Regulation, under 21CFR
	888.3390. This falls under the Orthopedic Panel.
Device Class	Class II
Classification Panel	Orthopaedics
Product Code	KWY
Predicate Device	1. "United" U2 Bipolar Implant (K101670)
	2. "United" U1 Hip System-Bipolar (K050269)
	3. "United" U1 Hip System--Femoral Head (K994078)
	4. "Stryker" UHR Universal Head Bipolar System (K800207)
	5. "Zimmer" VerSys Hip System--Femoral Head (K964769)
	6. "Exactech" AcuMatch L-Series Bipolar Endoprosthesis (K013211)
	7. "Aesculap" Aesculap BiPolar Acetabular Cup (K060707)

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Device Description:

U2 Bipolar Implant

Femoral Head, 22mm

Intended Use:

This device is intended for use in combination with UNITED Femoral System for cemented or cementless hip replacement. This device may be used for the following conditions:

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli and painful hip dysplasia.
Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
1. Correction of function deformity.
Revision procedures where other treatments or devices have failed. 4.

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(G) U2 Bipolar Implant and 22mm Femoral Head

ડ. Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Comparison to Predicate Device:

The subject device--U2 Bipolar Implant is identical to the cleared "United" U2 Bipolar Implant (K101670) except size distribution and the design of stopper ring. However, the size distribution is substantially equivalent to "Exactech" AcuMatch L-Series Bipolar Endoprosthesis (K013211), and the performance evaluation for stopper ring of subject device was also conducted. The differences between subject and predicate devices would not pose issues about safety and effectiveness.

Performance Data:

Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device:
a. Locking Mechanism of U2 Bipolar Implant
b. Range of Motion of U2 Bipolar Implant
c. Disassembly Force for Femoral Head and Stem

● Clinical Performance Data/Information

None provided as a basis for substantial equivalence.

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.