Revision of previous unsuccessful acetabular replacement.
Class III segmental and/or cavitary acetabular defects which make it difficult to achieve satisfactory results while using standard total hip replacement acetabular components and procedures.

For Full XPE Cup

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

This device is a single use implant and intended for cemented use only.

Device Description

"United" Locking Cage
The "United" Locking Cage is designed to achieve stable and lasting fixation of the severely deficient acetabulum. The "United" Locking Cage includes locking cage and several accessory components including: ischial flange, hook, cancellous locking screw and auto break-off locking nut. They are all manufactured from Ti6A14V which confirms to ASTM F136-13.

"United" Full XPE Cup
The "United" Full XPE Cup is designed for cemented use and assembled with a PMMA Spacer and an X-ray marking wire. The Full XPE Cup is manufactured from highly cross-linked UHMWPE which conforms to ASTM F2565-06. The UHMWPE raw material is in accordance with ASTM F648-14 and ISO 5834-1:2005. The PMMA Spacer and X-ray marking wire are made of PMMA (Medical Grade) and Co-20Cr-15W-10Ni alloy (ASTM F90-14), respectively. The X-ray marking wire is designed for X-ray image identification purpose. The "United" Full XPE Cup is available in a range of sizes to fit varying anatomical requirements.

The "United" Locking Cage can be used with correspondent sizes of "United" Full XPE Cup with bone cement. The "United" Full XPE Cup is also compatible with "United" Metal Femoral Head (K994078, K022520, K111546 and K122504) and "United" Ceramic Femoral Head (K103497) in correspondent sizes. The "United" Femoral Heads can be used with various types of "United" hip stems (K003237, K062978, K111546, K123550, K132207, K151316 and K152530).

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device (Locking Cage, Full XPE Cup). It details the device description, indications for use, and a comparison to predicate devices, along with performance data. However, this document does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner requested by your prompt.

The performance data section (page 6) states:

● Non-clinical Performance
Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device:

a. Structural compression stiffness of locking cage

b. ROM for Full XPE Cup

c. Bending fatigue testing of flanges

d. Locking strength of locking cage and cemented cup

e. Endurance testing

f. 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.

This indicates that the manufacturer performed non-clinical (benchtop) tests to demonstrate substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for a novel AI/software performance as implied by your prompt's questions (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance).

The "acceptance criteria" here implicitly refer to the device performing as safely and effectively as the predicate devices based on these engineering tests, but no specific numerical criteria (e.g., sensitivity, specificity, or specific threshold values for fatigue testing) are provided or explicitly referred to as "acceptance criteria" in this document.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: No explicit numerical acceptance criteria or detailed performance metrics are listed in this document in the format appropriate to an AI/software device. The document only lists the types of non-clinical tests performed.
Sample sized used for the test set and the data provenance: Not applicable, as this is a mechanical device, not an AI/software device with test sets of data. The "tests" are engineering evaluations (e.g., fatigue, compression).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical properties is established by physical measurement and engineering standards, not expert adjudication of images or data.
Adjudication method: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is for AI-assisted human reading, not a mechanical implant.
Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used: For mechanical tests, the "ground truth" is the physical property being measured (e.g., stiffness, strength), and the measurement itself is the truth, often against an industry standard.
The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document pertains to a mechanical orthopedic implant, not an AI or software as a medical device (SaMD). The regulatory approval is based on "substantial equivalence" to existing predicate devices through non-clinical (benchtop) engineering tests, not clinical studies or AI performance evaluations against expert-adjudicated ground truth.

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" written around it. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine.

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

August 25, 2017

United Orthopedic Corporation Ms. Gimpel Chien Regulation and Document Management No 57, Park Ave 2, Science Park Hsinchu 300 Taiwan

Re: K163441 Trade/Device Name: Locking Cage, Full XPE Cup Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, JDI Dated: July 31, 2017 Received: August 2, 2017

Dear Ms. 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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Indications for Use

510(k) Number (if known) K163441

Device Name Locking Cage, Full XPE Cup

Indications for Use (Describe)

For Locking Cage

Revision of previous unsuccessful acetabular replacement.
Class III segmental and/or cavitary acetabular defects which make it difficult to achieve satisfactory results while using standard total hip replacement acetabular components and procedures.

For Full XPE Cup

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, and painful hip dysplasia;
Inflammatory degenerative joint disease such as rheumatoid arthritis;
Correction of function deformity;
Revision procedures where other treatments or devices have failed;
Treatment of nonunion and femoral neck fractures of the proximal femur with head

involvement that is unmanageable using other techniques.

This device is a single use implant and intended for cemented use only.

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

☒ Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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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. 2217
Fax Number	+886-3-577156
Name of Contact Person	Gimpel ChienRegulation and Document Management
Date prepared	August 18, 2017
Name of Device
Trade Name	Locking Cage, Full XPE Cup
Common Name	Acetabular component
Regulation Name andNumber	The device classification for Locking Cage, Full XPE Cupare “prosthesis, hip, semi-constrained, metal/ceramic/polymer,cemented or non-porous, uncemented” and “prosthesis, hip,semi-constrained, metal/polymer, cemented” which arecontained in the Code of Federal Regulation, under 21CFR888.3353 and 21 CFR 888.3350, respectively. This fallsunder the Orthopedic Panel.
Device Class	Class II
Classification Panel	Orthopaedics
Product Code	LZO, JDI
Predicate Device	1. “Stryker Howmedica Osteonics” GAP-II RestorationAcetabular Shells (K980774)2. “Smith & Nephew” Cemented all polyethylene Acetabularcomponent (K991026)3. “United” U-Motion II Acetabular Component (K122185)

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Locking Cage, Full XPE Cup

1. "Howmedica" Trident® Crossfire® Polyethylene Liners (K021911)

Device Description:

"United" Locking Cage

The "United" Locking Cage is designed to achieve stable and lasting fixation of the severely deficient acetabulum. The "United" Locking Cage includes locking cage and several accessory components including: ischial flange, hook, cancellous locking screw and auto break-off locking nut. They are all manufactured from Ti6A14V which confirms to ASTM F136-13.

"United" Full XPE Cup

The "United" Full XPE Cup is designed for cemented use and assembled with a PMMA Spacer and an X-ray marking wire. The Full XPE Cup is manufactured from highly cross-linked UHMWPE which conforms to ASTM F2565-06. The UHMWPE raw material is in accordance with ASTM F648-14 and ISO 5834-1:2005. The PMMA Spacer and X-ray marking wire are made of PMMA (Medical Grade) and Co-20Cr-15W-10Ni alloy (ASTM F90-14), respectively. The X-ray marking wire is designed for X-ray image identification purpose. The "United" Full XPE Cup is available in a range of sizes to fit varying anatomical requirements.

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Locking Cage, Full XPE Cup

Indications for Use:

For Locking Cage

Revision of previous unsuccessful acetabular replacement. 1.

Class III segmental and/or cavitary acetabular defects which make it difficult to 2. achieve satisfactory results while using standard total hip replacement acetabular components and procedures.

For Full XPE Cup

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

This device is a single use implant and intended for cemented use only.

Comparison to Predicate Device:

"United" Locking Cage

The "United" Locking Cage is substantially equivalent to "Stryker Howmedica Osteonics" GAP-II Restoration Acetabular Shells (K980774) in indications, design rationale, dimension characteristic and sterilization method.

"United" Full XPE Cup

The Full XPE Cup is substantially equivalent to "Smith & Nephew" REFLECTION cross-linked UHMWPE Acetabular Components (K991026) in indications, material, design rationale, dimension characteristic and sterilization method.

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Performance Data:

● Non-clinical Performance

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

a. Structural compression stiffness of locking cage
b. ROM for Full XPE Cup
c. Bending fatigue testing of flanges
d. Locking strength of locking cage and cemented cup
e. Endurance testing
f. 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

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.