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.

Novation Element press-fit femoral stems with HA coating are intended for press-fit fixation.

Device Description

The proposed Exactech Novation Element Press-Fit Femoral Stem is a modification of the HA Coated MCS Total Hip System cleared through premarket notification #K990197 and 12/14 Acumatch Press-Fit Femoral Stem cleared through premarket notification #K041906.

The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:

the same indications for use
the same basic design features
incorporate the same materials
the same shelf life
are packaged and sterilized using the same materials and processes

The only modifications to the technological characteristics of the predicate devices are:

The trapezoidal cross-sectional geometry of the shaft has been slightly altered.
Horizontal grooves have been added to the shaft.

Standard orthopedic instrumentation (FDA class I) is used for implantation of the Novation Element Press-Fit Femoral Stem. These press-fit femoral components are designed such that an interference condition is created between the implant and host bone.

AI/ML Overview

The provided text describes a Special 510(k) Premarket Notification (K080980) for the Exactech Novation Element Press-Fit Femoral Stem. This type of submission is for modifications to previously cleared devices where the new device is substantially equivalent to existing predicate devices.

Based on the provided information, the concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as typically understood for AI/ML performance metrics (e.g., sensitivity, specificity, AUC) is not applicable here.

Here's why and what the document does provide:

Device Type: This is for a mechanical orthopedic implant (femoral stem for hip replacement), not an AI/ML diagnostic or predictive device.
Regulatory Pathway (Special 510(k)): For physical medical devices, a Special 510(k) focuses on demonstrating substantial equivalence to a predicate device through engineering evaluations, material testing, and design comparisons, rather than clinical performance trials with specific AI-like metrics.

Therefore, many of the requested fields regarding AI/ML performance, ground truth, expert opinions, and training/test sets are irrelevant to this specific document.

I will attempt to answer the relevant questions based on the provided text, and mark those that are not applicable (N/A) for this type of device and submission.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Demonstrated through)	Reported Device Performance (Summary)
Intended Use Equivalence: Same indications for use as predicate devices.	The proposed and predicate devices share the same indications for use.
Basic Design Features Equivalence: Similar basic design features to predicate devices.	The proposed and predicate devices share the same basic design features, with minor alterations (trapezoidal cross-section slightly altered, horizontal grooves added).
Material Equivalence: Incorporation of the same materials as predicate devices.	The proposed and predicate devices incorporate the same materials.
Shelf Life Equivalence: Same shelf life as predicate devices.	The proposed and predicate devices have the same shelf life.
Packaging & Sterilization Equivalence: Same packaging and sterilization methods as predicate devices.	The proposed and predicate devices are packaged and sterilized using the same materials and processes.
Functional Performance: Adequate for anticipated in vivo use.	"Testing and engineering evaluations were conducted verifying that the performance of the new Novation Element Press-Fit Femoral Stem is adequate for anticipated in vivo use." This includes demonstrating an interference fit between the implant and host bone for press-fit fixation.

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

Not Applicable (N/A): This is a mechanical device, and performance is demonstrated through engineering testing and design comparisons, not a clinical "test set" in the context of diagnostic AI/ML. The "testing and engineering evaluations" would involve material strength, fatigue, and geometric analysis, not patient data for a test set.

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

Not Applicable (N/A): Ground truth for a test set is not applicable here as this is not an AI/ML diagnostic device nor a clinical study generating patient-specific ground truth. The evaluation rests on engineering and material science principles.

4. Adjudication method for the test set

Not Applicable (N/A): No test set or human adjudication process is described for this mechanical device.

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 (N/A): This is for a mechanical implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human readers are not relevant.

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

Not Applicable (N/A): This is for a mechanical implant, not software or an algorithm.

7. The type of ground truth used

Not Applicable (N/A): For this device, "ground truth" would be established through engineering specifications, material standards, and biomechanical principles, not clinical outcomes or expert consensus in the typical AI/ML sense. The "substantial equivalence" framework means the predicate devices' long-term performance in implant use serves as a baseline.

8. The sample size for the training set

Not Applicable (N/A): This device does not involve a "training set" as it is not an AI/ML product.

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

Not Applicable (N/A): This device does not involve a "training set" or "ground truth" in this context.

Summary

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Summary of Safety and Effectiveness Special 510(k)

K08098000pg 1/3)

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

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

FDA Establishment Number 1038671

MAY - 6 2008

Contact: Xavier Sarabia Director of Regulatory Affairs

Date: April 1, 2008

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Summary of Safety and Effectiveness Special 510(k) KOBO990 (pg 213)

Trade or proprietary or model name(s):

Novation Element Press-Fit Femoral Stem

Information on devices to which substantial equivalence is claimed:

510(k)Number	Trade or Proprietary or Model Name	Manufacturer
K990197	HA coated MCS Total Hip System	Exactech, Inc.
K041906	12/14 Acumatch Press-Fit Femoral Stem	Exactech, Inc.

DESCRIPTION OF DEVICE MODIFICATIONS

The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:

· the same indications for use
· the same basic design features
· incorporate the same materials
· the same shelf life
· are packaged and sterilized using the same materials and processes

The only modifications to the technological characteristics of the predicate devices are:

. The trapezoidal cross-sectional geometry of the shaft has been slightly altered.
Horizontal grooves have been added to the shaft .

INDICATIONS

Page 2 of 3

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Summary of Safety and Effectiveness Special 510(k)

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.

The Novation Element Press-Fit Femoral Stem is intended for press-fit fixation.

Substantial Equivalence

Testing and engineering evaluations were conducted verifying that the performance of the new Novation Element Press-Fit Femoral Stem is adequate for anticipated in vivo use. In addition to the design similarities listed above, these results demonstrate that the proposed device is substantially equivalent to the identified predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted in a simple, bold black outline.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Exactech® Inc. % Mr. Xavier Sarabia Director of Regulatory Affairs 2320 N.W. 66th Court Gainesville, FL 32653

MAY - 6 2008

Re: K080980

Trade/Device Name: Exactech Novation Element Press-Fit Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained or non porous uncemented prosthesis Regulatory Class: Class II Product Code: MEH Dated: April 1, 2008 Received: April 7, 2008

Dear Mr. Sarabia:

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, Or vo and Cosmetic Act (Act) that do not require approval of a premarket approval application (DMA), 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, l'isting 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 max 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. Xavier Sarabia

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 the reporting 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Millman

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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Exactech®, Inc.

Exactech Novation Element Press-Fit Femoral Stems

Indications for Use

KOBO980 Lag1/17 510(k) Number:

INDICATIONS

Novation Element press-fit femoral stems with HA coating are intended for press-fit fixation.

Prescription Use

Over the Counter Use

Please do not write below this line

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil Rl. Ogle for MKM

(Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Number K080980

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.