The Exactech Optetrak® Unicondylar Knee System is intended for partial replacement of the medial or lateral articulating surface of the knee joint. The system is indicated for primary surgery in skeletally mature patients with one or more of the following clinical conditions:

. Non-inflammatory osteoarthritis, osteonecrosis and/or traumatic arthritis
트 Functional deformity
Tibial condyle or plateau fractures that are not manageable by other techniques
I Traumatic bone and/or cartilage lesions
All components are intended for cemented use only.

Device Description

The Exactech Optetrak® Unicondylar Knee system is comprised of six sizes of symmetric femoral components and six sizes of asymmetric (right and left side-specific) all-poly tibial components. These components articulate together and are used to replace a portion of the human knee joint that has been debilitated by injury or disease. Specifically, these components are used to replace the damaged biological articular geometry on the medial or lateral aspects of both right and left knees.

AI/ML Overview

This 510(k) summary describes a traditional medical device (knee prosthesis), not an AI/ML-driven device. As such, the requested information pertaining to AI/ML device studies (such as sample size for test sets and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) is not present in this document.

However, I can extract information related to the performance testing that was conducted for this device.

A table of acceptance criteria and reported device performance:

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Material Composition	Biocompatible and industry-standard materials for joint implants	Femoral component: Cobalt-chromium alloy (ASTM F-75)Tibial component: Ultra High Molecular Weight Polyethylene - UHMWPE (ASTM-F648)
Geometric Design	Sagittal and coronal plane curvature to reduce contact stresses and facilitate articulation kinematics, consistent with predicate devices.	Exactech Unicondylar femoral component has both sagittal and coronal plane curvature.Exactech Optetrak Unicondylar tibial component has both sagittal and coronal plane curvature, consistent with DePuy Preservation predicate device.
Functional Performance	Adequate for anticipated in vivo kinematic and loading conditions; compatible with intended use.	Functional testing and engineering analysis conducted demonstrated that the implant performance would be adequate for anticipated in vivo kinematic and loading conditions, and are compatible with the intended use.
Substantial Equivalence	Similar to existing market devices in materials, dimensions, and performance characteristics.	Determined to be substantially equivalent to similar devices (Zimmer MG, Link Endo-Modell, DePuy Preservation) in materials of construction, dimensions, and performance characteristics.

Here's an analysis of the study information based on the provided text, highlighting what is missing or not applicable due to the nature of the device:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document describes "Functional testing and engineering analysis" for a knee prosthesis. This type of testing typically involves mechanical bench testing, such as fatigue, wear, and strength tests, rather than clinical data from a "test set" as understood for AI/ML performance evaluation.
- Therefore, information on sample size (in terms of patient data) and data provenance (country, retrospective/prospective) is not applicable or provided in this context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For a traditional medical device like a knee implant, "ground truth" is typically established through engineering standards, mechanical testing protocols, and clinical outcomes evidence from predicate devices. There isn't a "ground truth" derived from expert consensus on images or clinical assessments in the same way as for an AI/ML diagnostic device.
- Therefore, this information is not applicable or provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- As described and explained above, this concept related to expert review and consensus on clinical data is not applicable to the type of performance testing reported for this device.
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:
- This is a traditional medical device (knee implant), not an AI/ML-driven device. Therefore, an MRMC study and analysis of AI assistance effect size is not applicable and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is a physical medical device, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" for performance is primarily based on:
  - Engineering and Material Standards: Compliance with ASTM standards (e.g., ASTM F-75 for cobalt-chromium alloy, ASTM-F648 for UHMWPE).
  - Functional Testing: Mechanical tests
  - Performance of Predicate Devices: The established clinical history and performance of legally marketed predicate devices (Zimmer MG, Link Endo-Modell, DePuy Preservation) serve as a benchmark for substantial equivalence. The "intended use" and "performance characteristics" of the new device are compared to these.
The sample size for the training set:
- This is a traditional medical device, not an AI/ML device that requires a "training set" of data. Therefore, this information is not applicable.
How the ground truth for the training set was established:
- As there is no "training set" for this type of device, this information is not applicable.

Summary

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510(k) Summary Pursuant to 21 CFR 807.92

1.	Submitted By:	Exactech, Inc.2320 N.W. 66th CourtGainesville, FL 32653
2.	Contact:	Dr. Gary MillerExecutive Vice President of Research andDevelopmentExactech, Inc.2320 N.W. 66th CourtGainesville, FL 32653Phone: (352) 377-1140Fax: (352) 378-2617
3.	Product:	Exactech Optetrak® Unicondylar Knee21 CFR Section 888.3530

21 CFR Section 888.3530 Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented Metal/Polymer

Class II

Product Code HR Y

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Description:

Intended Use:

. Non-inflammatory osteoarthritis, osteonecrosis and/or traumatic arthritis
트 Functional deformity
Tibial condyle or plateau fractures that are not manageable by other techniques
I Traumatic bone and/or cartilage lesions

All components are intended for cemented use only.

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Technological Characteristics and Substantial Equivalence:

Like the Zimmer MG (K942263) and Link Endo-Modell (K944186) femoral components, the Exactech Optetrak Unicondylar femoral component is built from cobaltchromium alloy (ASTM F-75). The DePuy Preservation (K010810) femoral component is also made from cobaltchromium. The Exactech Unicondylar femoral component has both sagittal and coronal plane curvature, which is consistent with the predicate component femoral geometries.

Like all three predicate components, the Exactech Optetrak Unicondylar tibial component is built from Ultra High Molecular Weight Polyethylene - UHMWPE (ASTM-F648). The Exactech Optetrak Unicondylar tibial component has both sagittal and coronal plane curvature, which is consistent with the DePuy Preservation predicate device. This curvature is intended to reduce contact stresses and facilitate anatomic-like articulation kinematics, however, it does not impose excessive constraint on the femoral component.

Performance Testing:

Functional testing and engineering analysis was conducted to verify that the implant performance would be adequate for anticipated in vivo kinematic and loading conditions.

The testing and analysis data collected for the Exactech Optetrak Unicondylar Knee components demonstrated that they are compatible with the intended use and substantially equivalent to the referenced predicate devices.

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Conclusions:

The Exactech Optetrak® Unicondylar Knee is substantially equivalent to similar devices existing in the market in materials of construction, dimensions, and performance characteristics. It has been determined to be an effective design and when used according to instructions for use, is a useful and valuable device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

OCT 1 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Simpson Senior Regulatory Representative Exactech, Inc. 2320 NW 66th Court Gainesville, Florida 32653

Re: K040889 Trade/Device Name: Exactech Optetrak® Unicondylar Knee Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: September 10, 2004 Received: September 13, 2004

Dear Ms. Simpson:

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 - Ms. Lisa Simpson

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/dsma/dsmamain.html

Sincerely yours,
Mark A. Melkerson

Celia M. Witten, Ph.D., M.D. 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 Statement

510(k) Number:	K04 0889
----------------	----------

Exactech Optetrak® Unicondylar Knee Device Name:

Intended Use: The Exactech Optetrak® Unicondylar Knee System is intended for partial replacement of the medial or lateral articulating surface of the knee joint. The system is indicated for primary surgery in skeletally mature patients with one or more of the following clinical conditions:

동 Non-inflammatory osteoarthritis, osteonecrosis and/or traumatic arthritis
디 Functional deformity
피 Tibial condyle or plateau fractures that are not manageable by other techniques
ਬ Traumatic bone and/or cartilage lesions

All components are intended for cemented use only.

X Prescription Use (Per CFR 801.109)

Over-the-counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mmh n Mellem

(Division of General, Restorative, and Neurological Devices

510(k) Number K040889

Regulation Number and Section

§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.