All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.

Device Description

This Special 510(k) application supports the substantial equivalency of the Ziramic™ Zirconia (Zyranox®) 12/14 Femoral Heads relative to Exactech's predicate 12/14 Alumina (BIOLOX® forte) Ceramic Femoral Heads (#K032964). The design modifications include a change in the ceramic material composition from alumina to zirconia, and the addition of +7mm and +10 mm skirted heads for the 28mm, 32 mm and 36 mm outer diameter sizes. The proposed Ceramic Femoral Heads are composed of Morgan Advanced Ceramic's Zyranox® zirconia material and have a European 12/14 taper design.

AI/ML Overview

The provided text is related to a 510(k) submission for a medical device, specifically Ziramic™ Zirconia 12/14 Femoral Heads. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on new acceptance criteria and a study to prove meeting them in the way one might for a novel diagnostic or AI-driven device.

Therefore, the information regarding acceptance criteria and studies demonstrating device performance, as typically requested for AI/diagnostic devices, is not present in the provided document. This document focuses on the material change from alumina to zirconia ceramic and the addition of specific skirted head sizes, and claims substantial equivalence based on testing and engineering evaluations.

Here's how to interpret the request in the context of the provided document:

A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document in the format requested. The document mentions "successful results" from "Testing and engineering evaluations" but does not detail the specific acceptance criteria for these evaluations or their quantitative performance. The "device performance" here refers to the material properties of Zyranox® zirconia, which are described in FDA Master File MAF-343, but not explicitly in this summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or not provided. The "tests" mentioned are likely mechanical and material property tests on the femoral heads themselves, not clinical trials with human subjects or data sets in the typical sense for AI/diagnostic devices.
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): Not applicable. "Ground truth" in this context would relate to the material science and mechanical properties, not expert clinical assessment of a test set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 component of a hip replacement system, not an AI diagnostic tool involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device would be established through material science testing, biomechanical testing, and engineering evaluations to ensure the zirconia material meets performance standards for orthopedic implants. The document states "The material properties of Zyranox® are described in FDA Master File MAF-343," indicating that the properties were characterized and documented.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that uses training sets.
How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The document describes a Special 510(k) submission for the Exactech® Ziramic™ Zirconia 12/14 Femoral Heads. The study proving the device meets acceptance criteria is implied through "Testing and engineering evaluations." The regulatory pathway taken (510(k)) aims to demonstrate substantial equivalence to a predicate device (Exactech 12/14 Alumina Ceramic Femoral Head #K032964), rather than proving new efficacy or safety claims against specific quantitative acceptance criteria in a clinical trial format.

The primary change for this submission is a change in material composition from alumina to zirconia and the addition of new skirted head sizes. The "material properties of Zyranox®" (the zirconia material) are referenced in an FDA Master File (MAF-343). The conclusion states that "Based on successful results we conclude that the proposed devices are substantially equivalent..."

Without access to the actual "Testing and engineering evaluations" and the FDA Master File MAF-343, the specific acceptance criteria and detailed performance data cannot be extracted from this summary document. This document is a regulatory summary, not a detailed technical report or clinical study publication.

Summary

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K050398 p1/3

NOV 1 8 2005

Exactech® Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) -Summary of Safety and Effectiveness

Sponsor: Exactech® Inc. 2320 N.W. 66th Court Gainesville, Florida 32653

(352) - 377 - 1140 Phone: Fax: (352) - 378 - 2617

FDA Establishment Number 1038671

Maritza Elias Contact: Regulatory Representative

Date: November 15, 2005

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|K05C398r r^{2/3}

Exactech® Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) -Summary of Safety and Effectiveness

Trade / Proprietary Name:	Exactech
Model Name:	Ziramic™ Zirconia 12/14 Femoral Head
Classification Name:	Prosthesis, Hip, Semi-Constrained,Metal/Ceramic/Polymer, Cementedor Non-Porous, Uncemented
Product Code:	LZO, LPH
C.F.R. Section:	21 CFR 888.3353, 21 CFR 888.3358
Device Class:	II
Classification Panel:	Orthopedic

Legally Marketed Devices for Substantial Equivalence Comparison:

Exactech 12/14 Alumina Ceramic Femoral Head #K032964

Device Description:

INDICATIONS

rev. 11/15/05

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Koso398p%

Exactech® Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) -Summary of Safety and Effectiveness

CONTRAINDICATIONS

Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.

The Zirconia Ceramic Head is contraindicated for use with any other acetabular cup liner than an ultra high molecular weight polyethylene (UHMWPE) liner or a metal backed UHMWPE liner.

Exactech 12/14 Zirconia Ceramic Femoral Heads

The proposed Ceramic Femoral Heads are composed of Morgan Advanced Ceramic's Zyranox® zirconia material and have a European 12/14 taper design. The material properties of Zyranox® are described in FDA Master File MAF-343.

Conclusion:

Testing and engineering evaluations were conducted to verify that the performance of the new 12/14 zirconia ceramic femoral heads would be adequate for anticipated in vivo loading when mated with Exactech titanium alloy 12/14 Femoral Stems. Based on successful results we conclude that the proposed 12/14 Ziramic™ Zirconia 12/14 Femoral Heads devices are substantially equivalent Exactech's predicate 12/14 Alumina Femoral Heads (#K032964).

rev. 11/15/05

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an emblem that resembles an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2005

Maritza Elias Regulatory Representative Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K050398

Trade/Device Name: Exactech Ziramic™ Zirconia 12/14 Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, LPH Dated: October 28, 2005 Received: November 1, 2005

Dear Ms. Elias:

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- Maritza Elias

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 Office 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 Manufacturers, International 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/industry/support/index.html.

Sincerely yours,
Mark McMillan

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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Exactech®, Inc. Ziramic™ Zirconia 12/14 Femoral Heads Special 510(k) - Indication for Use

510(k) Number: ---- KC50398

INDICATIONS

CONTRAINDICATIONS

Exactech Hip Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, · in neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age, or activity level would cause the surgeon to expect early failure of the system.

The Zirconia Ceramic Head is contraindicated for use with any other acetabular cup liner than an ultra high molecular weight polyethylene (UHMWPE) liner or a metal backed UHMWPE liner.

Prescription Use

Or Over the Counter Use

Please do not write below this line - use another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

(Division Sign-Off) (Division Sign-Off)
Division of General, Restorative, Division rological Devices

510(k) Number

Section 3 Page 1 of 1

rev. 10/25/05

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.