The MectaCer BIOLOX® forte Femoral Heads are intended for mechanical fixation to a mating hip stem and indicated for treatment of patients who are candidates for total or partial hip arthroplasty in primary or revision surgery.

The patient should be skeletally mature.

The patient's condition should be due to one or more of the following:

Severely painful and/or disabled joint as a result of osteoarthritis, post-. traumatic arthritis, rheumatoid arthritis, or psoriatic arthritis.
Congenital hip dysplasia .
. Ankylosing spondylitis
Avascular necrosis of the femoral head .
Acute traumatic fracture of the femoral head or neck .
Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.

Device Description

The MectaCer BIOLOX® forte Femoral Heads are ceramic ball heads intended for mechanical fixation to a mating hip stem and indicated for the treatment of patients who are candidates for total or partial hip arthroplasty to provide increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery.

The MectaCer BIOLOX® forte Femoral Heads consist of High Purity Aluminium Oxyde Ceramic, Al2 O3 per standard ISO 6474:1994, Implants for surgery --Ceramics materials based on high purity alumina, Type A. The MectaCer BIOLOX® forte Femoral Heads are available in various sizes from 28, 32 and up to 36 mm diameters.

AI/ML Overview

Here's an analysis of the provided text regarding the MectaCer BIOLOX® forte Femoral Heads, focusing on acceptance criteria and supporting studies:

This submission (K073337) is a 510(k) Premarket Notification, which demonstrates substantial equivalence to legally marketed predicate devices, rather than a clinical trial proving device efficacy against specific acceptance criteria for performance. Therefore, the information provided primarily refers to bench testing and adherence to international standards for the device's material and mechanical properties, not a study evaluating clinical performance (e.g., patient outcomes, diagnostic accuracy).

The document does not describe a study in the traditional sense of evaluating an algorithm or AI's performance against specific clinical acceptance criteria for diagnosis or treatment. Instead, it details the engineering and material performance of a hip implant component.

Here's a breakdown of the requested information based on the provided text, with notes where information is not applicable to this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are standards for the material and mechanical performance of the femoral head, not diagnostic or clinical accuracy. The "reported device performance" is that the device conforms to these standards.

Acceptance Criteria (Standard)	Reported Device Performance
ISO 6474:1994 (Implants for surgery -- Ceramic materials based on high purity alumina)	MectaCer BIOLOX® forte Femoral Heads consist of High Purity Aluminium Oxyde Ceramic, Al2 O3 per standard ISO 6474:1994, Implants for surgery --Ceramics materials based on high purity alumina, Type A.
ISO 7206-10, 2003 (Implants for surgery Partial and total hip-joint prosthesis - Part 10: Determination of resistance to static load of modular femoral heads)	Performance testing was conducted in accordance with this standard.
ASTM F-2009-00 (Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses)	Performance testing was conducted in accordance with this standard.
AAMI/ANSI/ISO 11137 (Sterilization of health care products – Radiation)	Performance testing was conducted in accordance with this standard.
FDA's "Guidance Documents for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems", January 10, 1995	Performance testing was conducted in accordance with this guidance document.
Conclusion from Manufacturer	"Actual device performance as tested conforms to applicable standards and FDA guidance."
Substantial Equivalence to Predicate Devices	The device is "substantially equivalent to Plus Ceramic Ball Heads 28, 32 & 36, and Exactach® 12/14 Alumina Femoral Heads with respect to indications for use and technological characteristics."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "sample size" in the context of clinical data or patient cases. The testing described is bench testing of the physical device. Therefore, the "sample size" would refer to the number of femoral head units subjected to mechanical and material tests. This number is not provided in the summary.
Data Provenance: The data provenance is from laboratory testing/bench testing conducted by the manufacturer, MEDACTA International SA, located in Switzerland. It is not retrospective or prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable. This is a physical device (hip implant component) and the "ground truth" is established by adherence to engineering and material standards, not by expert consensus on clinical findings or images. The "ground truth" for the material composition and mechanical properties is based on the specifications within the cited ISO and ASTM standards.

4. Adjudication Method for the Test Set

Not Applicable. As the testing is for physical properties against defined standards, there is no need for expert adjudication in the same way as with diagnostic image interpretation. The "adjudication" is met by demonstrating conformity to the specified technical parameters of the standards.

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 device is a passive hip implant component, not an AI or diagnostic tool. Therefore, no MRMC study involving human readers and AI assistance was conducted or would be relevant.

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

Not Applicable. This device is a passive hip implant component, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" is based on established international standards for ceramic materials (ISO 6474), mechanical testing of hip prostheses (ISO 7206-10), and taper connections (ASTM F-2009-00), as well as sterilization (AAMI/ANSI/ISO 11137). These standards define the expected physical and material properties that the device must meet.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI or machine learning device.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set, this question is not relevant.

Summary

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K073337 (fg 1 of 3)

Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of a stylized black graphic to the left of the word "Medacta" in black lowercase letters. Below "Medacta" is the word "International" in a smaller font, also in black. To the right of "International" is a small graphic of a plus sign.

510(k) Summary

FEB 13 2008

Manufacturer: MEDACTA International SA Strada Regina CH6874 Castel San Pietro Switzerland Phone (+41) 91 696 60 60 (+41) 91 696 60 66 FAX

Contact Person: Ms. Natalie J. Kennel Consultant NJK & Associates, Inc. 13721 Via Tres Vista San Diego, CA 92129 USA Phone: (858) 705-0350 Fax: (858) 764-9739 email: NKennel@nikconsulting.com
Date Prepared: February 4, 2008

DEVICE INFORMATION

Trade/Proprietary Name: MectaCer BIOLOX® forte Femoral Heads Common/Classification Name: Hip Joint, metal/ceramic/polymer, semiconstrained, cemented or non-porous uncemented prosthesis

21 CFR 888.3353 Class II Device Product Code: LZO

Predicate Devices:

The MectaCer BIOLOX® forte Femoral Heads are substantially equivalent to Plus Ceramic Ball Heads 28, 32 & 36, which were cleared under K070928 and Exactach® 12/14 Alumina Femoral Heads, which were cleared under K032964.

Product Description:

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K073337 (pg 2 of 3)

increased patient mobility and reduced pain by replacing the damaged hip joint, in primary or revision surgery.

Indications for Use:

The patient's condition should be due to one or more of the following:

. Severely painful and/or disabled joint as a result of osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or psoriatic arthritis.
Congenital hip dysplasia .
Ankylosing spondylitis .
Avascular necrosis of the femoral head .
. Acute traumatic fracture of the femoral head or neck
Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.

Performance Testing

No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the MectaCer BIOLOX® forte Femoral Heads was conducted in accordance with the following international standards and FDA quidance documents.

. ISO 6474:1994, Implants for surgery -- Ceramic materials based on high purity alumina
ISO 7206-10, 2003, Implants for surgery Partial and total hip-joint . prosthesis - Part 10: Determination of resistance to static load of modular femoral heads.
ASTM F-2009-00, Test Method for Determining the Axial Disassembly . Force of Taper Connections of Modular Prostheses
. AAMI/ANSI/ISO 11137 Sterilization of health care products – Radiation
FDA's "Guidance Documents for the Preparation of Premarket . Notifications for Ceramic Ball Hip Systems", January 10, 1995.

Conclusion:

The data and information provided in this submission support the conclusion that the MectaCer BIOLOX® forte Femoral Heads are substantially equivalent to its

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K073337 (pg 3 of 3)

predicate devices, Plus Ceramic Ball Heads 28, 32 & 36, and Exactech® 12/14 Alumina Femoral Heads with respect to indications for use and technological characteristics. Actual device performance as tested conforms to applicable standards and FDA guidance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

FEB 13 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDACTA International SA % Ms. Natalie J. Kennel NJK & Associates, Incorporated 13721 Via Tres Vista San Diego, California 92129

Re: K073337

Trade/Device Name: MectaCer BIOLOX® forte Femoral Heads 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: November 27, 2007 Received: November 29, 2007

Dear Ms. Kennel:

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

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Page 2 - Ms. Natalie J. Kennel

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. This letter will allow you to begin marketing your device as described in your Section 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mulhausen

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

Enclosure

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Indications for Use

510(k) Number (if known): K073337

Device Name: MectaCer BIOLOX® forte Femoral Heads

Indications for Use:

The patient should be skeletally mature.

The patient's condition should be due to one or more of the following:

Severely painful and/or disabled joint as a result of osteoarthritis, post-. traumatic arthritis, rheumatoid arthritis, or psoriatic arthritis.
Congenital hip dysplasia .
. Ankylosing spondylitis
Avascular necrosis of the femoral head .
Acute traumatic fracture of the femoral head or neck .
Failure of previous hip surgery: joint reconstruction, internal fixation, . arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement where sufficient bone stock is present.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Briems

Division of Greeral, Restorative, Page _ of and Neurological Devices

510(k) Number K073337

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.