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

This device is designed for cementless use.

Device Description

This subject device is a size extension of the cleared "UNITED" UTF Stem - reduced (K123550, K132207). The indications, materials, design of this subject device are identical to the cleared "UNITED" UTF Stem - reduced (K123550, K132207) except for size distribution. "UNITED" UTF Stem - reduced is a modular, wedge-shaped stem with 12/14 neck taper and 130° neck angle, which is indicated for use in primary or revision hip arthroplasty. UTF Stem - reduced is available with standard offset and high offset options to restore hip biomechanics.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically a hip joint prosthesis. It addresses a size extension for an already cleared device. As such, the document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device through a new comprehensive study.

Therefore, much of the information requested in your prompt regarding specific acceptance criteria, detailed study design for proving device performance, sample sizes for test/training sets, expert adjudication methods, and MRMC studies, is not present in this type of regulatory submission. This document highlights that the new device shares the same indications, materials, and design (with minor modifications) as previously cleared devices.

Here's an analysis based on the information available:

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

The document does not provide a table of acceptance criteria with numerical targets and reported performance in the way one might expect for a new device study. Instead, it relies on demonstrating that the new size extension performs "as safe and effective as the predicates" by conducting specific mechanical tests required for orthopedic implants.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance
Stem Fatigue Test	Conducted and demonstrated substantial equivalence to predicates.
Neck Fatigue Test	Conducted and demonstrated substantial equivalence to predicates.
Biocompatibility
Bacterial Endotoxin Test	Conducted and met the endotoxin limit as specified in USP <161>.
Functionality
Range of Motion	Test conducted (implies satisfactory results to achieve equivalence).

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

Sample Size for Test Set: Not explicitly stated as a "test set" in the context of a clinical or image-based AI study. The "test set" here refers to the actual physical devices (UTF Stem, reduced, #0, #00) subjected to mechanical and biocompatibility testing. The exact number of units tested for each mechanical test is not specified in this summary.
Data Provenance: The document does not specify the country of origin for the mechanical testing data. The manufacturer, United Orthopedic Corporation, is based in Hsinchu, Taiwan. The type of testing is non-clinical (laboratory-based mechanical and biocompatibility tests). These are prospective tests performed on the device.

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 is not applicable to the type of device and submission. This is a mechanical/biocompatibility evaluation of a physical orthopedic implant, not an AI or image analysis device that requires expert ground truth labeling.

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

Not applicable. There is no human adjudication process described for the mechanical and biocompatibility tests performed on the physical device. The tests have predefined pass/fail criteria based on engineering standards and regulatory guidelines (e.g., USP <161> for endotoxin limits), not expert 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 is not an AI-assisted device or an imaging diagnostic device.

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

Not applicable. This is not an AI-driven algorithm.

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

The "ground truth" for this device's performance relies on established engineering principles, international standards for mechanical testing of implants, and biological safety standards (e.g., USP <161> for endotoxins). Performance is measured against these objective standards and comparison to the predicate device's known performance, not against expert consensus, pathology, or outcomes data in the way an AI diagnostic device would.

8. The sample size for the training set

Not applicable. This is not an AI device, so there is no training set in that context.

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

Not applicable. There is no training set.

Summary of what the document does communicate:

Purpose of Submission: This 510(k) is for a "size extension" of an already cleared hip stem (UTF Stem, reduced, #0, #00).
Demonstration of Safety and Effectiveness: The primary method is demonstrating substantial equivalence to previously cleared predicate devices (K123550, K132207, K110245).
Key Argument for Equivalence: The subject device shares identical indications for use, materials, and design (except for size distribution and minor design modifications that "do not change the intended use or fundamental scientific technology") with the predicates.
Non-Clinical Performance Data: To support equivalence, the following tests were conducted:
- Stem Fatigue Test
- Neck Fatigue Test
- Range of Motion
- Bacterial Endotoxin Testing (met USP <161> limits)
Clinical Performance Data: "None provided as a basis for substantial equivalence." This is common for minor modifications or size extensions of already cleared devices, as new human clinical trials are typically not required if substantial equivalence can be demonstrated through non-clinical means.

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

June 8, 2017

United Orthopedic Corporation Gimpel Chien Regulatory Affairs Manager No 57, Park Ave 2, Science Park Hsinchu. 300 TW

Re: K163193 Trade/Device Name: UTF Stem, reduced, #0, #00 Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, KWY, LZO Dated: April 14, 2017 Received: April 17, 2017

Dear Gimpel Chien:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K163193

Device Name

UTF Stem, reduced, #0, #00

Indications for Use (Describe)

This device is indicated for use in total hip replacement undergoing primary and revision surgery for the following conditions:

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

This device is designed for cementless use.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K163193 PAGE 1 OF 3

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. 2217
Fax Number	+886-3-577156
Name of Contact Person	Gimpel ChienRegulation and Document Management
Date prepared	November 10, 2016
Name of Device
Trade Name	UTF Stem, reduced, #0, #00
Common Name	Hip Stem
Regulation Name andNumber	The device classification for UTF Stem, reduced, #0, #00 is"Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis." and is contained in theCode of Federal Regulation, under 21CFR 888.3358. Thisfalls under the Orthopedic Panel.
Device Class	Class II
Classification Panel	Orthopaedics
Product Code	LPH, KWY, LZO
Predicate Device	1. “UNITED” UTF Stem, Reduced (K123550)2. “UNITED” UTF Stem-reduced, Additional Sizes(K132207)3. “UNITED” UTF Stem (K110245)

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Device Description:

Indications for Use:

This device is indicated for use in total hip replacement or bipolar hip replacement undergoing primary and revision surgery for the following conditions:

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, 1. ankylosis, protrusion acetabuli, and painful hip dysplasia.
Inflammatory degenerative joint disease such as rheumatoid arthritis. 2.
Correction of functional deformity. 3.
1. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Revision procedures where other treatments or devices have failed. 5.

This device is designed for cementless use.

Comparison to Predicate Device:

The subject device is a size extension to the cleared "UNITED" UTF Stem-Reduced (K123550, K132207). The indications, materials, design, manufacturing process of the subject device are identical to the cleared "UNITED" UTF Stem-Reduced (K123550, K132207). Besides, the indications, materials, manufacturing process of the subject device are identical to the cleared "UNITED" UTF Stem (K110245), except for the reduced distal width and the enlarged thread diameter of the impact hole. However, the design modifications do not change the intended use or fundamental scientific technology. The

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(9) UTF Stem, reduced, #0, #00

subject device is smallest size option of UTF reduced stem and the mechanical properties including neck fatigue and stem fatigue have been conducted to evaluate the safe and performance and test results demonstrated that the subject device is as safe and effective as the predicates.

Performance Data:

● Non-clinical Performance

Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device:

a. Stem Fatigue Test
b. Neck Fatigue Test
c. Range of Motion
d. Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP <161>

Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices.

● Clinical Performance Data/Information

None provided as a basis for substantial equivalence.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.