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.

Cemented femoral stems and cemented acetabular cups are intended for cemented . fixation only.
Press-fit femoral stems and acetabular cups are intended for press-fit fixation. .
Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

Device Description

The proposed Exactech Novation Element Press-Fit Femoral Stems are a modification of the Exactech Novation Element Press-Fit Femoral Stems cleared through premarket notification #K080980.

The predicate and proposed devices have the same intended use and the same basic fundamental scientific technology.

The modified devices share the following similarities with predicate devices:

The same design features (e.g. stem geometry, femoral head taper design, stem . insertion feature)
The same materials (titanium alloy, hydroxyapatite coating) .
The same shelf life (5 years), and ●
Are packaged and sterilized using the same materials and processes (gamma . radiation sterilization to a sterility assurance level of 10°).

This submission proposes expanding the scope of Novation Element femoral stems by adding new components with modified neck geometry and adding alternative coating suppliers.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Exactech® Novation® Element Press-Fit Femoral Stem), which is a premarket notification to the FDA. This type of document is used to demonstrate substantial equivalence to a predicate device, not to present a study proving the device meets acceptance criteria in the way a diagnostic or AI-driven device might.

Therefore, the requested information categories (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this kind of submission. The "acceptance criteria" here refer to the regulatory criteria for demonstrating substantial equivalence, not performance metrics from a clinical or diagnostic study.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Regulatory)	Reported Device Performance/Evidence
Mechanical Strength/Fatigue (Worst Case)	Mechanical testing confirmed that the proposed device, under worst-case conditions, has fatigue strength equivalent to other comparable legally marketed femoral stems (i.e., the predicate device and other similar devices).
Geometric Features Correspondence to Anatomy	An engineering evaluation determined that the geometric features of the proposed device correspond to the anatomical features of the femur.
Hydroxyapatite (HA) Coating Characterization	A comparison of the HA coating characterization information of predicate and proposed devices was conducted as outlined in the FDA guidance document "510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants." The implication is that the coatings are comparable/acceptable.
Maintenance of Predicate Device Similarities (Basis for SE)	The modified devices share the same design features (stem geometry, femoral head taper design, stem insertion), same materials (titanium alloy, hydroxyapatite coating), same shelf life (5 years), and are packaged and sterilized using the same materials and processes (gamma radiation sterilization to a sterility assurance level of 10⁻⁶).

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

Not Applicable (N/A). This is a 510(k) submission for a physical orthopedic implant. The "testing" refers to engineering and material characterization, not patient data sets. The "test set" in the context of device performance in humans or with AI algorithms does not apply.

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

N/A. Ground truth from experts is relevant for diagnostic performance evaluation, not for demonstrating substantial equivalence of a physical implant's mechanical properties or design.

4. Adjudication method for the test set:

N/A. Adjudication methods are used in studies involving human interpretation or data analysis, not for the engineering tests described here.

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:

N/A. This device is a passive orthopedic implant, not an AI-driven or diagnostic tool. MRMC studies are irrelevant.

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

N/A. This refers to AI algorithm performance evaluation, which is not applicable to an orthopedic implant.

7. The type of ground truth used:

N/A (in the typical sense of "ground truth" for diagnostic studies). The "truth" in this context is established through engineering principles, material science standards, and comparison to the predicate device's known characteristics. For example, "fatigue strength equivalent to other legally marketed femoral stems" is a comparative engineering truth, not a clinical ground truth.

8. The sample size for the training set:

N/A. No training set is used as this is not a machine learning or AI device.

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

N/A. No training set or associated ground truth.

Summary

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KI13320 (pa 112)

Exactech® Novation® Element Press-Fit Femoral Stem Special 510(k) - 510(k) Summary of Safety and Effectiveness

MAR 1 6 2012

Exactech® Inc. Sponsor: 2320 N.W. 66tt Court Gainesville, FL 32653

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

FDA Establishment Number 1038671

Vladislava Zaitseva Contact: Regulatory Affairs Specialist

December 21, 2011 Date:

Trade or Proprietary or Model Name(s):

Exactech® Novation® Element Press-Fit Femoral Stem

Common Name:

Press-Fit Femoral Stem component

Classification Name:

Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, . Calicum-Phosphate (21 CFR Section 888.3353, Class II, Product Code MEH)

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or Proprietary or Model Name	Manufacturer
K080980	Novation Element Press-Fit Femoral Stem	Exactech, Inc

Indications for Use:

Cemented femoral stems and cemented acetabular cups are intended for cemented . fixation only.
Press-fit femoral stems and acetabular cups are intended for press-fit fixation. .
Femoral heads and endoprostheses are intended for use in cemented and press-fit � applications.

{1}------------------------------------------------

Exactech® Novation® Element Press-Fit Femoral Stem Special 510(k) - 510(k) Summary of Safety and Effectiveness

Device Description:

The proposed Exactech Novation Element Press-Fit Femoral Stems are a modification of the Exactech Novation Element Press-Fit Femoral Stems cleared through premarket notification #K080980.

The predicate and proposed devices have the same intended use and the same basic fundamental scientific technology.

The modified devices share the following similarities with predicate devices:

The same design features (e.g. stem geometry, femoral head taper design, stem . insertion feature)
The same materials (titanium alloy, hydroxyapatite coating) .
The same shelf life (5 years), and ●
Are packaged and sterilized using the same materials and processes (gamma . radiation sterilization to a sterility assurance level of 10°).

This submission proposes expanding the scope of Novation Element femoral stems by adding new components with modified neck geometry and adding alternative coating suppliers.

Substantial Equivalence Conclusion:

The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed device to the predicate Novation Element Press-Fit Femoral Stems:

An engineering evaluation to determine that the geometric features of the . proposed device correspond to the anatomical features of the femur.
Mechanical testing to confirm that the proposed device, under worst case . conditions, has fatigue strength equivalent to other comparable legally marketed femoral stems.
A comparison of the HA coating characterization information of predicate and . proposed devices as outlined in the FDA guidance document "510(K) Information Needed for Hydroxyapatite Coated Orthopedic Implants".

In addition to the design similarities listed above, the results demonstrate that the proposed device is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird-like figure, with three curved lines representing its wings or body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

MAR 1 6 2012

Exactech, Inc. % Ms. Vladislava Zaitseva Regulatory Affairs Specialist 2320 N.W. 66th Court Gainesville, FL 32653

Re: K113320

R 113320
Trade/Device Name: Exactech® Novation® Element Press-Fit Femoral Stem 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: MEH Dated: January 24, 2012 Received: January 25, 2012

Dear Ms. Zaitseva:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your becasil >10(t) presidentially equivalent (for the indications felerenced above and nave ustimansal predicate devices marketed in interstate for use stated in the encrosure) to regard annual date of the Medical Device Amendments, or to commerce prior to May 26, 1976, the excordance with the provisions of the Federal Food, Drug, devices that have been reclassined in assess as a proval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approva and Cosment Act (Act) that to not require approvince in esseral controls provisions of the Act. The You may, inerelore, market the device, becjoct to me gentration, listing of
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the rict meridae road prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Frease note: CDICT Good not be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Sec above) into time major regulations affecting your device can be may be subject to additional confrois: Existing may so again and to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addi found in the Code of I cacal Regarations), cour device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substitution with other requirements of the Act
that FDA has made a determination that your device complies with of concies . You that FDA has made a decermination that Joint stered by other Federal agencies. You must or any Federal statutes and regulations administration of registration and listing (21
comply with all the Act's requirements, including, but not managering of medical comply with all the Act 3 requirements, and medical device reporting (teporting of medical
CFR Part 807); labeling (21 CFR Part 801); medical struing programs; as CFR Part 807); labeling (21 CFR 803); medical as not september +++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

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Page - 2 - Ms. Vladislava Zaitseva

forth in the quality systems (OS) 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,

Ke Pete Thim

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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Exactech® Novation® Element Press-Fit Femoral Stem Special 510(k) - Indications for Use

KI13320 (pg VI) 510(k) Number:

Device Name: Exactech® Novation® Element Press-Fit Femoral Stem

INDICATIONS

Cemented femoral stems and cemented acetabular cups are intended for cemented . fixation only.
. Press-fit femoral stems and acetabular cups are intended for press-fit fixation.
Femoral heads and endoprostheses are intended for use in cemented and press-fit . applications.

Prescription Use and/or X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

De Usal

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

510(k) Number K113320

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.