(192 days)
This device is used 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 osteoarthritis, 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.
The U2 Acetabular Components are designed for uncemented application and single use only.
The U2 Acetabular Component is designated to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U2 Acetabular Component has 14 sizes, hemispherical design and without or with clustered bone screw holes for variable screw locking angle. The metallic shell is manufactured from forged Titanium alloy (ASTM F620) and its outer surface has two types of coating. Ti plasma spray and IIA/Ti plasma spray. The acetabular liner is machined from extruded UHMWPE bars (ISO 5834/1) and its minimum thickness is 4 18 mm to reduce contact stress. If supplemental bone screw fixation is deemed necessary, Titanium Cancellous Bone Screws (ASTM F136) can be inserted through the screw holes without interfering with the seating of the acetabular liner.
This 510(k) summary for the U2 Acetabular Component describes a medical device, not an AI/ML medical device. Therefore, a study demonstrating the device meets acceptance criteria using the specified AI/ML-centric framework (test set, ground truth, experts, MRMC studies, standalone performance, etc.) is not applicable here.
The document primarily focuses on demonstrating substantial equivalence to predicate devices through design, material composition, HA coating, and a locking mechanism, supported by mechanical test data.
However, I can extract information related to "acceptance criteria" and the "study" conducted from the provided text, reinterpreting them in the context of a traditional medical device submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (from Mechanical Test Data) |
|---|---|
| Static Tensile Strength (of HA/Ti plasma spray) | Indicated substantial equivalence to predicate devices. |
| Static Shear Strength (of HA/Ti plasma spray) | Indicated substantial equivalence to predicate devices. |
| Push-out Test Data (for liner-cup locking mechanism) | Indicated substantial equivalence to predicate devices. |
| Lever-out Test Data (for liner-cup locking mechanism) | Indicated substantial equivalence to predicate devices. |
| Torque-out Test Data (for liner-cup locking mechanism) | Indicated substantial equivalence to predicate devices. |
Explanation of "Acceptance Criteria" and "Reported Device Performance":
For this type of device, the "acceptance criteria" are implicitly defined by the performance characteristics of the legally marketed predicate devices. The "reported device performance" demonstrates that the new device's mechanical properties (static tensile, static shear, push-out, lever-out, and torque-out for the liner-cup locking mechanism) are comparable to, and thus "substantially equivalent" to, these predicate devices. The goal is to show it performs at least as well as, or within acceptable limits of, the established predicate devices.
2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML algorithm evaluated on a data set of images or clinical data. The "test set" would refer to physical prototypes or samples of the device undergoing mechanical testing. The document does not specify the number of samples used for these mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in this context is not established by human experts reviewing data, but rather by standardized mechanical testing methods (e.g., ASTM standards for material properties and device performance). The "data provenance" (country of origin, retrospective/prospective) is also not relevant in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Mechanical test results are objective measurements, not subjective evaluations requiring adjudication.
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 (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance claims of the U2 Acetabular Component is derived from mechanical testing results, adhering to established engineering standards for orthopedic implants (e.g., ASTM F620 for Titanium alloy, ISO 5834/1 for UHMWPE bars) and comparative performance against legally marketed predicate devices.
8. The sample size for the training set: Not applicable. This is not an AI/ML device with a "training set."
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
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9 U2 Acetabular Component
Summary
510(k) Summary of Safety and Effectiveness
| Submitted By: | United Orthopedic CorporationNo. 57, Park Ave. 2, Science Park, Hsinchu, 300, TaiwanTel: 886-3-5773351Fax: 886-3-5777156 |
|---|---|
| Date | January 14th, 2005 |
| Contact person | Gene Huang / Regulatory Affairs |
| Device Name: | U2 Acetabular Component |
| Common Name: | Acetabular Component |
| Classification Name andReference: | 21CFR 888.3360 Hip Joint femoral (hemi-hip) metalliccemented or uncemented prosthesis. |
| Predicate Device: | UNITED U1 Hip Prosthesis (K994078)Howmedica Osteonics Trident® Hemispherical acetabularshells (AD and AD-HA) (K013676)Howmedica Osteonics Trident® Porous Titanium AcetabularComponent (K010170) |
Device Description:
The U2 Acetabular Component is designated to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U2 Acetabular Component has 14 sizes, hemispherical design and without or with clustered bone screw holes for variable screw locking angle. The metallic shell is manufactured from forged Titanium alloy (ASTM F620) and its outer surface has two types of coating. Ti plasma spray and IIA/Ti plasma spray. The acetabular liner is machined from extruded UHMWPE bars (ISO 5834/1) and its minimum thickness is 4 18 mm to reduce contact stress. If supplemental bone screw fixation is deemed necessary, Titanium Cancellous Bone Screws (ASTM F136) can be inserted through the screw holes without interfering with the seating of the acetabular liner.
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9 U2 Acetabular Component
Intended Use:
The U2 Acetabular Component is used 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 osteoarthritis, avascular necrosis, 1. ankylosis, protrusio acetabuli, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis, 2.
- Correction of function deformity, 3.
- Revision procedures where other treatments or devices have failed; and 4.
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur เก with head involvement that is unmanageable using other techniques.
The U2 Acetabular Component is designed for uncemented application and is single use only.
Mechanical test data:
The static tensile and shear strengths of HA/Ti plasma spray and the push-out, lever-out and torque-out test data for the liner-cup locking mechanism indicated that U2 Acetabular Component is substantial equivalent to the predicate devices.
Substantial Equivalence Information:
The design concept, material composition, HA coating and locking mechanism of U2 Acetabular Component are similar with currently marketed predicate devices. The U2 Acetabular Component is substantial equivalent to the predicate devices, UNITED UI Hip system (K994078) and Howmedica Osteonics Trident® Hemispherical acetabular shells (AD and AD-HA) (K013676).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a stylized graphic of a human figure. The graphic is composed of three curved lines that form the silhouette of a person's head and shoulders. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Public Health Service
AUG 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Gene Huang Manager Regulatory Affairs United Orthopedic Corporation _ . No. 57, Park Avenue 2, Science Park Hsinchu China (Taiwan) 300
Re: K050262
Trade/Device Name: U2 Acetabular Component Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: II
Product Code: LWJ, MEH Dated: July 12, 2005 Received: July 15, 2005
Dear Mr. Huang:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
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Page 2 - Mr. Gene Huang
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you've organization of substantial equivalence of your device to a legally prematics notification "The a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general micronal and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark Williamson
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (if known): ___K050262
Device Name: _U2 Acetabular Component r
ﺔ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
Indications for Use:
This device is used 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 osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia:
- · Inflammatory degencrative 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.
The U2 Acetabular Components are designed for uncemented application and single use only.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANDTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
*ivision Sign-Off)
Division of General, Restorative
nd Neurological Devices
Number K050262
Page 1 of 1
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.