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

· Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, ankylosis, protrusio acetabuli, 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; and .
· Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Description

The U1 Hip System is designated as a total hip joint replacement. It is a modular type of product system. The followings are the major design features.

Femoral Stem: The component has seven sizes of options, tri- wedge design, straight stem, 1340 neck-stem angle, a Morse type taper to receive modular heads, porous coated surface on proximal portion and satin finished on distal. There are w/ and w/o calcar collar designs. This device is produced from cast Co-Cr-Mo alloy (ASTM F75).

Femoral Head; The head diameter is 26mm. There are four adjustments of options. Std. +3, +6, +9, respectively. It is fabricated from wrought Co-Cr-Mo alloy bars (ASTM F1537) by machining.

Acetabular Component: This device has ten sizes of options, hemispherical design, porous coated surface on metallic shell, clustered bone screw holes, spherical screw holes for variable screw locking angle, PMMA cement plug, easy snap-in and take out mechanism, 16 options for angle adjustment, minimum 4.33mm thickness of UHMWPE liner. The metallic shell is produced from cast Co-Cr-Mo alloy (ASTM F75). The plastic liner is machined from extruded UHMWPE bars (ISO 5834/1)

Bone Screw: This device is a 6.5 mm cancellous bone screw. It has six lengths of options (15 mm ~ 40 mm), and has a shallow screw head.

AI/ML Overview

The provided document describes the predicate device information contained in a 510(k) Pre-market Notification for the U1 Hip System. It is not an AI/ML device, therefore, the information requested about acceptance criteria, study details, and AI/ML specific evaluations (like human reader improvement with AI, standalone performance, training sets, etc.) is not applicable to this document.

However, I can extract the closest relevant information from the document regarding the device's performance justification:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Acceptance Level (Implied/Predicate-based)	Reported Device Performance
U1 Hip System vs. Predicate (DePuy AML® Hip Prosthesis)	Essential Equivalence	Achieves essential equivalence in design concepts for femoral components (established by FEA).
Porous Coating Static Tensile and Shear Strength	> 20 MPa	More than 20 MPa
Porous Coating Volume Porosity	Between 30% and 70%	Between 30% and 70%
Porous Coating Average Pore Size	Between 100 and 1000 microns	Between 100 and 1000 microns
Porous Coating Thickness	Between 500 and 1,500 microns	Between 500 and 1,500 microns

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

Sample Size: Not applicable. This device is not an AI/ML device that uses a "test set" in the conventional sense of data samples. The evaluation was based on engineering analysis and material properties.
Data Provenance: Not applicable.

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

Not applicable. This is not an AI/ML device.

4. Adjudication method for the test set

Not applicable. This is not an AI/ML device.

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/ML device.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" in this context is the safety and effectiveness profile of the predicate device (DePuy AML® Hip Prosthesis), as well as established biomechanical and material science principles and standards (e.g., ASTM F75 for Co-Cr-Mo alloy, ISO 5834/1 for UHMWPE). The U1 Hip System aims to demonstrate substantial equivalence to this predicate.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Study That Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets acceptance criteria, in this context, is primarily articulated through Finite Element Analysis (FEA) and material property testing:

FEA Study:
- The U1 stem was analyzed using finite element analysis.
- Finding: The FEA results indicated that the U1 stem's performance (relative motion, load transfer) was "somewhat less sensitive to changes in friction condition than they are for the more extensively coated AML" (the predicate device).
- Conclusion: This analysis established the "essential equivalence of the design concepts for the U1 and AML femoral components." This implies that the U1 design is considered to perform similarly and acceptably to the established predicate.
Material Property Testing of Porous Coating:
- Tests: Static tensile and shear strength, volume porosity, average pore size, and porous coating thickness were tested.
- Findings: The reported values (more than 20MPa for strength, 30-70% for volume porosity, 100-1000 microns for average pore size, and 500-1500 microns for thickness) meet or exceed the implied acceptance criteria for such coatings, which are typically based on established medical device standards and the performance of successful predicate devices. The document explicitly states these findings.

Overall Justification:

The substantial equivalence was based on features comparable to the predicate device, including the Co-Cr-Mo alloy substrate, straight stem type, beaded porous coated surface on the proximal portion of the stem and acetabular cup, and Morse taper locked with heads. The FEA and material testing provided the engineering and scientific basis to support this comparability and substantial equivalence.

Summary

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X994078

DEC = 4 2000

ਹੈ U1 HIP SYSTEM

Summary

510(k) Summary of Safety and Effectiveness

Company:	United Orthopedic Corporation
Address:	No 57, Park Ave. 2, Science Park, Hsinchu, 300, Taiwan
Phone Number:	886-3-5773351
Fax Number:	886-3-5777156
Date Prepared:	November 16, 1999.
Device Name:	U1 Hip System
Common Name:	Hip joint prostheses or replacement

Hip joint, Semi-Constrained, Metal/Polymer, Porous Classification Name: Uncemented Prosthesis per 21CFR 888.3358. DePuy AML® Hip Prosthesis Predicate Device:

Device Description:

The U1 Hip System is designated as a total hip joint replacement. It is a modular type of product system. The followings are the major design features.

Femoral Head; The head diameter is 26mm. There are four adjustments of options. Std. +3, +6, +9, respectively. It is fabricated from wrought Co-Cr-Mo alloy bars (ASTM F1537) by machining.

Bone Screw: This device is a 6.5 mm cancellous bone screw. It has six lengths of options (15 mm ~ 40 mm), and has a shallow screw head.

Intended Use:

The U1 hip system is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, 1.

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9 U1 HIP SYSTEM

ankylosis, protrusio acetabuli, 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; and
1. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Basis for Substantial Equivalence:

Features comparable to predicate devices, DePuy AML® Hip prosthesis, include Co-Cr-Mo alloy substrate, straight type stem, beaded porous coated surface on the proximal portion of stem and acetabular cup, and Morse taper locked with heads.

Test Results:

The Ul stem was analyzed using finite element analysis. The results for the U1 stem (relative motion, load transfer, etc.) are somewhat less sensitive to changes in friction condition than they are for the more extensively coated AML. The analysis establishes the essential equivalence of the design concepts for the U1 and AML femoral components.

The static tensile and shear strength of the beaded porous coating are more than 20MPa. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1000 microns and a porous coating thickness between 500 and 1,500 microns.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4. 2000

Mr. Mellen Liu Regulatory Affairs Coordinator United Orthopedic Corporation 57, Park Avenue 2, Science Park Hsinchu 300, Taiwan, R.O.C.

Re: K994078/S1 Trade Name: U1 Hip System Regulatory Class: II Product Code: LPH Dated: September 8, 2000 Received: September 11, 2000

Dear Mr. Liu:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have and we have determined the device is substantially equivalent (for the indications for use above and we have actering as marketed in interstate commerce prior to May 28, 1976, the stated in the enorours) to teater with the enterest that have been reclassified in enacificin and of the Federal Food, Drug, and Cosmetic Act (Act). 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, controls pro horons or use, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket ripps of ally ware found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspotions, the Food and Diam may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 - Mr. Mellen Liu

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific arrivitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for m. Pro aluguestions on the promotion and advertising of your device, (201) 594-4639. Traditionally, and (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). "Other general information on your responsibilities under the Act may be obtained from the Division of Small monmation on your responsive at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Narls N Milburn

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

、 4 . . . . 1000

Enclosure

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510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________

Device Name: _U1 Hip System

Indications for Use:

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

· Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, ankylosis, protrusio acetabuli, 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; and .
· Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation

Prescription Use __ (per 21 CFR 801.109) OR

Over-The Counter Use

for Mich N. Milliken
(Division Sign-Off)

Division of General Restorative Devices
510(k) Number K994078

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.