Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia.
Inflammatory degenerative joint disease such as rheumatoid arthritis.
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
Revision procedures where other treatments or devices have failed.
Patients suffering from disability due to previous fusion.
Patients with acute femoral neck fractures.

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

Device Description

UCP (United Cement Polished) stem is a triple tapered, polished, collarless stem. It is available for three series: Standards offset, High offset and Long stem to accommodate various surgical requirements. UCP Stem is intended to be fixed only with the use of PMMA bone cement and should be used with centralizer and cement restrictor. UCP stem, centralizer and cement restrictor are made of Co-Cr-Mo alloy (ASTM F799-11), PMMA and UHMWPE (ASTM F648-14/ISO5834), respectively. UCP Stem is intended to use for primary or revision hip arthroplasty. For total hip arthroplasty, UCP Stem can be used with UNITED acetabular liner, cup and femoral head. For bipolar hip replacement, UCP Stem can be used with UNITED bipolar prosthesis.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for a medical device called the "UCP Stem," which is a hip joint prosthesis. The document describes the device, its indications for use, and a comparison to predicate devices, along with performance data.

However, the document does not contain information regarding acceptance criteria or a study proving the device meets specific acceptance criteria in the way envisioned by the request. Instead, the performance data section focuses on non-clinical mechanical tests to demonstrate safety and effectiveness for a hip stem, in comparison to predicate devices for substantial equivalence. There is no mention of a study involving human subjects or expert assessment of performance data in relation to specific acceptance criteria.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's a breakdown of what can be extracted or inferred, and what cannot:

1. Table of acceptance criteria and reported device performance:

The document does not specify quantitative acceptance criteria with corresponding performance metrics for the device. It states that "the test results comply with the recommendations according to the FDA guidance 'Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Protheses'." This implies a qualitative acceptance of meeting guidance recommendations rather than predefined numerical thresholds.

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance
Stem Fatigue Test	Complies with recommendations per FDA guidance "Non-clinical Information for Femoral Stem Protheses"
Neck Fatigue Test	Complies with recommendations per FDA guidance "Non-clinical Information for Femoral Stem Protheses"
Range of Motion	Complies with recommendations per FDA guidance "Non-clinical Information for Femoral Stem Protheses"
Mechanical Testing for Ceramic Femoral Head while Collocating with UCP Stem	Complies with recommendations per FDA guidance "Non-clinical Information for Femoral Stem Protheses"
Clinical Performance	None provided as a basis for substantial equivalence.

The document does not specify the quantitative outcomes of these tests, only that they "comply with the recommendations."

2. Sample size used for the test set and the data provenance:

Sample size for non-clinical tests: Not specified in the document.
Data provenance: Non-clinical (laboratory tests) conducted by United Orthopedic Corporation. Country of origin for the testing itself is not explicitly stated, but the company is based in Taiwan. The data is non-clinical performance data, not retrospective or prospective human clinical data.

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

This is not applicable as the document describes non-clinical mechanical tests, not clinical studies requiring expert ground truth for interpretation of outcomes.

4. Adjudication method for the test set:

Not applicable, as there is no mention of a test set requiring adjudication in the context of human interpretation or clinical endpoints.

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. The UCP Stem is a physical medical device (hip prosthesis), not an AI diagnostic or assistance tool. Therefore, an MRMC study and AI-related effect size are outside the scope of this device.

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

Not applicable. The UCP Stem is a physical medical device, not an algorithm.

7. The type of ground truth used:

For the non-clinical mechanical tests, the "ground truth" would be the engineering specifications, material properties, and performance benchmarks outlined in relevant ASTM/ISO standards and FDA guidance documents (e.g., ASTM F799-11, ASTM F648-14/ISO5834, and FDA Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Protheses).

8. The sample size for the training set:

Not applicable. This is for a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set mentioned.

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 faces in profile, overlapping each other, representing the department's focus on people and health.

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

March 14, 2016

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

Re: K152530 Trade/Device Name: UCP Stem 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, LWJ, KWY Dated: January 29, 2016 Received: February 1, 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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Indications for Use

510(k) Number (if known) K152530

Device Name UCP Stem

Indications for Use (Describe)

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia.
Inflammatory degenerative joint disease such as rheumatoid arthritis.
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
Revision procedures where other treatments or devices have failed.
Patients suffering from disability due to previous fusion.
Patients with acute femoral neck fractures.

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 HoRegulation and Document Management
Date prepared	March 3, 2016
Name of Device
Trade Name	UCP Stem
Common Name	Hip Stem
Regulation Name andNumber	The device classification for UCP Stem is:21 CFR 888.3353: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis;21 CFR 888.3350: Hip joint metal/polymer semi-constrained cemented prosthesis;21 CFR 888.3360: Hip joint femoral (hemi hip) metallic cemented or uncemented prosthesis;21 CFR 888.3390: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis. This falls under the Orthopedic Panel.
Device Class	Class II
Classification	Orthopedics
Product Code	LZO, JDI, LWJ, KWY
Predicate Device	1. “DePuy” DePuy C-Stem AMT (K082239)2. “Zimmer” CPT® 12/14 Hip Prostheses (K030265)

Device Description:

UCP (United Cement Polished) stem is a triple tapered, polished, collarless stem. It is available for three series: Standards offset, High offset and Long stem to accommodate

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19 UCP Stem

various surgical requirements. UCP Stem is intended to be fixed only with the use of PMMA bone cement and should be used with centralizer and cement restrictor. UCP stem, centralizer and cement restrictor are made of Co-Cr-Mo alloy (ASTM F799-11), PMMA and UHMWPE (ASTM F648-14/ISO5834), respectively. UCP Stem is intended to use for primary or revision hip arthroplasty. For total hip arthroplasty, UCP Stem can be used with UNITED acetabular liner, cup and femoral head. For bipolar hip replacement, UCP Stem can be used with UNITED bipolar prosthesis.

Indications for Use:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia.
1. Inflammatory degenerative joint disease such as rheumatoid arthritis.
1. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.
1. Revision procedures where other treatments or devices have failed.
Patients suffering from disability due to previous fusion. న్.
1. Patients with acute femoral neck fractures.

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

Comparison to Predicate Device:

From view of the material, design rationale, intended use and sterilization method, UCP Stem is substantial equivalent to the predicate devices. The difference between the subject and the predicate devices is size distribution. However, the stem length of UCP Stem is within the size range of the predicate devices. The difference of size distribution does not affect the intended use of the device or alter the fundamental scientific technology of the device. As a result, UCP Stem is substantially equivalent to the predicate devices.

Performance Data:

Non-clinical Performance

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UCP Stem

Tests as follows were conducted to evaluate the safety and effectiveness of the subjected device, and the test results comply with the recommendations according to the FDA guidance "Guidance for Industry and FDA Staff: Non-clinical Information for Femoral Stem Protheses".

The following mechanical tests of the UCP Stem were performed:

a. Stem Fatigue Test
b. Neck Fatigue Test
c. Range of Motion
d. Mechanical Testing for Ceramic Femoral Head while Collocating with UCP Stem

● 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.