Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
Correction of functional deformity.
Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.
The device is intended for cementless use.

Device Description

U-Motion II PS Cup is an extension of cleared "UNITED" U-Motion II Acetabular System (K122185). The indications, major design features, materials, major manufacture processing and methods, size distribution of this subject are identical to the cleared U-Motion II Acetabular System (K122185). This device is manufactured from titanium alloy forging (ASTM F620) which are forged by titanium alloy bars (ASTM F136). The outer surface of U-Motion II PS+ Cup is coated with CP Ti power (ASTM F1580), and the coating layer is thicker than the cleared U-Motion II PS Cup (K122185). U-Motion II PS* Cup includes cluster-holed, no-hole and multi-hole series, and there are nineteen sizes of acetabular shell available, ranging from 44 through 80 mm outer diameter in 2 mm increments.

AI/ML Overview

The provided text is a 510(k) Summary for the "U-Motion II PS+ Cup" acetabular cup, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of a clinical trial or AI model validation.

Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable in this regulatory submission for a orthopedic implant.

Here's an analysis based on the available information:

Description of Acceptance Criteria and Proving Device Meets Them

The "acceptance criteria" in this context are for demonstrating substantial equivalence to a legally marketed predicate device, as required for 510(k) clearance by the FDA. The study proving the device meets these criteria is the comparison presented in the 510(k) summary, specifically focusing on physical and mechanical properties.

The core "acceptance criteria" are that the device shares the same intended use, materials, basic design features, and performs at least as safely and effectively as the predicate device, or any differences do not raise new questions of safety and effectiveness.

The document states:
"The mechanical properties of the modified surface have been evaluated to conform to FDA guidance: 'Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA' and 'Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement.' The analysis results demonstrate that the coating layer thickness increase would not affect the safety and effectiveness."

This indicates that the acceptance criteria for the device involved adherence to specific FDA guidance documents for mechanical property testing of orthopedic implants with modified metallic surfaces. The "study" proving this was the mechanical property evaluation of the modified surface.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for an orthopedic implant extension, specific numerical performance metrics like sensitivity, specificity, accuracy (which would be common for AI/diagnostic devices) are not presented in this summary. Instead, the "performance" is about meeting safety and effectiveness standards through material and mechanical testing.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from Text)	Reported Device Performance
Substantial Equivalence	- Indications for Use are identical to predicate.	Identical. The U-Motion II PS+ Cup has the same indications as the predicate "UNITED" U-Motion II Acetabular System (K122185) (Painful, disabling joint disease, revision, clinical management problems, correction of functional deformity, treatment of nonunion femoral neck and trochanteric fracture).
	- Materials are identical to predicate.	Identical (Titanium alloy forging (ASTM F620), CP Ti power (ASTM F1580)).
	- Geometry and size distribution are identical to predicate.	Identical (e.g., 44-80 mm outer diameter in 2 mm increments, cluster-holed, no-hole, multi-hole series).
	- Sterilization method is identical to predicate.	Identical.
Mechanical Properties	- Conform to FDA guidance: "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA" and "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement."	"The analysis results demonstrate that the coating layer thickness increase would not affect the safety and effectiveness." This implies successful demonstration of mechanical properties comparable to or exceeding the predicate and meeting standard requirements despite the increased coating thickness. Specific numerical values for mechanical properties are not provided in this summary.
Safety and Effectiveness	- Any differences (e.g., thicker coating) do not raise new questions of safety and effectiveness.	"The analysis results demonstrate that the coating layer thickness increase would not affect the safety and effectiveness."

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 used for the test set: Not applicable in this context. The "test set" here refers to physical components undergoing mechanical testing, not patient data or images. The specific number of physical samples tested is not disclosed in the summary.
Data provenance: Not explicitly stated for the mechanical testing. This would typically be generated by the manufacturer's R&D or an accredited testing lab.

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)

Number of experts: Not applicable. Ground truth in this context refers to the results of mechanical and material property tests (e.g., tensile strength, fatigue resistance), which are objectively measured, not subject to expert consensus in the same way as diagnostic image interpretation.
Qualifications of experts: N/A.

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

Adjudication method: Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for physical product testing.

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

MRMC study: No, this is not an AI/diagnostic device. This is a medical implant (acetabular cup).

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

Standalone performance: Not applicable. This is not an AI algorithm.

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

Type of ground truth: The "ground truth" for this device revolves around objective engineering and material science measurements, such as:
- Material composition analysis (e.g., ASTM F620, ASTM F136, ASTM F1580 standards).
- Dimensional accuracy checks.
- Mechanical strength tests (e.g., fatigue, static strength), as per the specified FDA guidance documents.
- Verification of coating thickness and adhesion.

8. The sample size for the training set

Sample size for the training set: Not applicable. This is not an AI/machine learning device.

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

How ground truth was established: Not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/1 description: The image shows the text "U-Motion II PS+ Cup". The text is written in a simple, sans-serif font. The word "U-Motion" is followed by "II PS+ Cup". There is a logo to the left of the text.

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 02, 2013	SEP 0 3 2013
Contact Person	Fang-Yuan Ho
	Regulation and Document Management Manager
Proprietary Name:	U-Motion II PS+ Cup
Common Name:	Acetabular Cup
Device Classification	Hip joint metal/ceramic/polymer semi-constrained cemented
Name and Reference:	or nonporous uncemented prosthesis under 21CFR 888.3353
	This falls under the Orthopedics panel.
Device Class	Class II
Panel Code	Orthopaedics Device
Device Product Code:	LZO, LWJ, KWY, MEH
Predicate Device:	"UNITED" U-Motion II Acetabular System (K122185)

Device Description:

UOC-FDA-030

Page: 7-1/2

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ਤੇ U-Motion II PS+ Cup

acetabular shell available, ranging from 44 through 80 mm outer diameter in 2 mm increments.

Indications:

The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
1. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
1. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
1. Correction of functional deformity.
1. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.

The device is intended for cementless use.

Basis for Substantial Equivalence:

The indications, materials, geometry, size distribution and sterilization method of U-Motion II PS Cup are identical to the predicate device "UNITED" U-Motion II Acetabular Cup (K122185).

Performance Data:

The mechanical properties of the modified surface have been evaluated to conform to FDA guidance: "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis; Guidance for Industry and FDA" and "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement." The analysis results demonstrate that the coating fayer thickness increase would not affect the safety and effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 symbol that resembles a human figure embracing or supporting another form, possibly representing health and well-being.

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

September 3, 2013

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

Re: K132455 Trade/Device Name: U-Motion II PS* 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, LWJ, KWY, MEH Dated: August 2, 2013 Received: August 6, 2013

Dear Fang-Yuan 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 Part 801); medical device reporting (reporting of medical

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Page 2 - Fang-Yuan Ho

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" (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/dcfault.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 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/ResourcesforYou/Industry/default.htm.

Sincercly yours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

K132455 510 (k) Number (if known): _

Device Name: __ U-Motion II PS+ Cup __

Indications for Use:

The device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
1. Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
1. Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
1. Correction of functional deformity.
1. Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.

The device is intended for cementless use.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Elizabeth L. Frank -S

Page 1 of 1

Division of Orthopedic Devices

UOC-FDA-030

. Page: 6-1 / 1

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.