The Bencox Forte and Bencox Delta ceramic heads is intended for use in total or partial hip arthroplasty in primary or revision surgery for the following conditions: a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed hip arthroplasty

Device Description

The Bencox Biolox Ceramic Head is a component of a Hip Prosthesis System and intended for mechanical fixation to a mating hip stem, with a standard 12/14 taper. It is intended to articulate between both Highly Cross Linked UHMWPE as well as Conventional UHMWPE.

The Bencox Ceramic Head is available as standard type and is manufactured from bio-inert alumina ceramic, Al2O3 as per ASTM F603 / ISO 6474. The ceramic femoral balls heads range in diameter from 28 mm to 40 mm with small, medium & large versions.

Radiation (gamma) sterilization is used for Bencox Forte and Bencox Delta Biolox ceramic heads. Sterilization by Co-60 gamma irradiation has been validated to a sterility assurance level (SAL) of 10-6 by the bioburden method, according to ISO 11137-1 & ISO 11137-2. Following sterilization packaging was validated for a shelf life of 5 years for BENCOX Forte & Delta ceramic femoral heads.

AI/ML Overview

The provided text describes the 510(k) summary for the BENCOX® Forte & BENCOX® Delta femoral heads, which are ceramic components for hip arthroplasty. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria in the context of AI/software device studies.

Therefore, many of the requested elements pertaining to AI/software device evaluation (e.g., sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this submission, as it concerns a physical medical device (femoral heads).

However, I can extract the information on performance testing and acceptance criteria as presented for this physical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Test)	Reported Device Performance
Component Testing on Titanium Test Tapers (per CeramTec AG VA 02 04 4129, ISO 7206-10)	Performed. (Implicitly met standards as substantial equivalence was granted. The document states "All required testing per 'Guidance Document for the Preparation of Premarket Notifications of Ceramic Ball Hip Systems' were performed.")
Influence of Diameter and Neck Length on Burst Strength (Burst test setup as per ISO 7206-10)	Performed. (Implicitly met standards as substantial equivalence was granted.)
Sterilization Validation (per ISO 11137-1 & ISO 11137-2 - Radiation)	Validated to a sterility assurance level (SAL) of 10^-6 by the bioburden method.
Shelf Life Validation for Sterilization Packaging	Validated for a shelf life of 5 years for BENCOX Forte & Delta ceramic femoral heads.
Substantial Equivalence (Indications, Design Principles, Operating Principles, Materials, Packaging)	Demonstrated to predicate devices: MEDACTA International SA; MectaCer BIOLOX forte Femoral Heads (K073337), DePuy Orthopedics, Inc., DePuy Delta Ceramic Femoral Head (K062748), Corentec Co., Ltd., Coren Total Hip System & Bencox Bipolar Cup System (K103431 & K112019). "Any differences ... do not raise new issues of safety or efficacy."

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

Sample Size: Not explicitly stated for each test, but standard test methods (e.g., ISO 7206-10, ISO 11137) would have defined sample sizes for physical product testing.
Data Provenance: Not applicable in the sense of patient data. The tests are laboratory-based mechanical and sterilization validations of the physical device.

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

Not applicable. Ground truth for a physical device like a ceramic femoral head is established through adherence to international standards and validated testing procedures by qualified technicians and engineers in accredited laboratories.

4. Adjudication method for the test set

Not applicable. The "adjudication method" typically refers to expert consensus for ground truth establishment in clinical or imaging studies. For physical device performance, the acceptance is based on meeting the specifications and standards outlined in the test protocols.

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 a physical medical device, not an AI/software device involving human readers.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used

Mechanical Performance: Adherence to international standards (e.g., ISO 7206-10) and established biomechanical testing protocols. The "ground truth" is that the device passes or fails these pre-defined mechanical tests.
Sterilization: Demonstrated Sterility Assurance Level (SAL) of 10^-6, verified by bioburden methods as per ISO 11137.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of physical device submission.

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

Not applicable. There is no concept of a "training set" for this type of physical device submission.

Summary

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K121665 (pg 1/3)

510(K) SUMMARY

EP 25 2012

Corentec Co., Ltd.

BENCOX® Forte & BENCOX® Delta

4th June, 2012

ADMINISTRATIVE INFORMATION

Manufacturer	Corentec Co., Ltd.
	247 Giro-ri, Ipjang-myeon, Seobuk-Gu
	Cheonan-si, Chungchongnam-do, 331-822 South Korea
	Telephone: +82-41-585-7114
	Fax: +82-41-585-7113
Official Contact	J.S. Daniel
	Project Manager - RA/QA
	Corentec Co., Ltd
	11th Chungho Tower, 748-1 Banpo 1 Dong
	Seocho Gu, Seoul, Korea 137-040
	Ph: +82 2 3445 5492
	Fax: +82 2 3445 5497

Email: jsdaniel@corentec.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	Bencox Forte & Bencox Delta
Common Name:	Femoral Head Prosthesis
Classification Regulations:	21 CFR 888.3353
Class	II
Product Codes:	LZO
Classification Panel:	Orthopedic Products Panel
Reviewing Branch:	Orthopedic Devices Branch

INTENDED USE

b. Inflammatory degenerative joint disease, such as rheumatoid arthritis

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c. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques d. Patients with failed previous surgery where pain, deformity, or dysfunction persists e. Revision of previously failed hip arthroplasty

DEVICE DESCRIPTION

SUBSTANTIAL EQUIVALENCE TO MARKETED DEVICES

BENCOX Forte & BENCOX Delta Biolox components are substantially equivalent in indications and design principles to the predicate devices, each of which has been determined by FDA to be substantially equivalent:

MEDACTA International SA; MectaCer BIOLOX forte Femoral Heads cleared . under K073337,
DePuy Orthopedics, Inc., DePuy Delta Ceramic Femoral Head cleared under . K062748,
Corentec Co., Ltd., Coren Total Hip System & Bencox Bipolar Cup System . cleared under K103431 & K112019 (Femoral Heads).

PERFORMANCE TESTING

Performance testing of the Bencox Forte/Delta Femoral Heads was conducted in accordance with the international standards. All required testing per "Guidance Document for the Preparation of Premarket Notifications of Ceramic Ball Hip Systems" were performed.

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Component testing of BIOLOX forte ball head 28-12/14 L on titanium test tapers . per CeramTec AG test procedure VA 02 04 4129, ISO 7206-10.
Influence of diameter and neck length on burst strength of BIOLOX forte and . BIOLOX delta ball heads with taper type 12/14. Burst test setup as per ISO 7206-10.
Sterilization validation as per ISO 11137 1 & 2 Sterilization of health care . products - Radiation.

Any differences in technological characteristic between the subject and predicate devices do not raise new issues of safety or efficacy of the BENCOX Forte & BENCOX Delta Biolox components for its intended use.

Overail, the BENCOX Forte & BENCOX Delta Biolox components have the following similarities to the predicate devices:

has the same intended use, .
uses the same operating principles, .
incorporates the same basic designs, .
incorporates the same or similar materials, and ●
has similar packaging and sterilized using the same materials and processes. .

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

SEP 25 2012

Corentec Co., Ltd. Seoul Office % J.S. Daniel· Project Manager - RA/QA 11th Chungho Tower 748-1 Banpo 1 Dong Seocho Gu, Seoul Republic of Korea 137-040

Re: K121665

Trade/Device Name: BENCOX® Forte & BENCOX® Delta 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 Dated: August 28, 2012 Received: August 30, 2012

Dear Mr. Daniel

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.

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Page 2 - Mr. J.S. Daniel

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: BENCOX Forte & BENCOX Delta

The Bencox Forte and Bencox Delta ceramic heads are intended for use in total or partial hip arthroplasty in primary or revision surgery for the following conditions:

a) Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b) Inflammatory degenerative joint disease, such as rheumatoid arthritis
c) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
d) Patients with failed previous surgery where pain, deformity, or dysfunction persists
e) Revision of previously failed hip arthroplasty.

Prescription Use: X _ (Per 21 CFR 801 Subpart D) AND / OR

Over-The Counter Use: (Per 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)

A. Suls.

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

×121665 510(k) Number

Corentec Co. Ltd

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.