The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Comprehensive Knee Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.

The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present.

The OPTETRAK Logic CC Total Knee System is indicated for cemented use only.

Device Description

This submission proposes dimensional modifications to features common to all Optetrak Logic tibial inserts, Optetrak Logic trapezoidal tibial trays, and Optetrak Logic Combo tibial trays. These modifications are designed to enhance intraoperative assembly.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Exactech Optetrak Logic Enhanced Assembly," a knee joint prosthesis. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study to prove acceptance criteria for an AI device.

Therefore, most of the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment for an AI device cannot be extracted from this document, as it describes a physical medical implant, not an AI system.

However, I can provide the limited information that is present within the document:

1. Table of Acceptance Criteria and Reported Device Performance:

This document describes mechanical testing performed on the device:

Acceptance Criteria / Test Conducted	Reported Device Performance (Summary)
Micromotion testing	Results demonstrate substantial equivalence to cited cleared predicate devices.
Shear testing	Results demonstrate substantial equivalence to cited cleared predicate devices.

Note: The document states "Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic and Optetrak Logic CC devices are substantially equivalent to cited cleared predicate Optetrak Logic devices." It does not provide specific numerical acceptance criteria or detailed performance metrics against those criteria within this summary. It refers to these studies as being "referenced" within the full 510(k) submission.

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to mechanical engineering studies of a physical device, not a test set of data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI devices involving expert review is not relevant here. The "ground truth" in this context would likely be engineering specifications and mechanical performance standards, established by engineers.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is not a human-in-the-loop diagnostic study for an AI 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. This document is for a physical medical implant, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical tests, the ground truth would typically be established by engineering standards, material properties, and comparative performance against predicate devices which themselves have established safety and effectiveness.

8. The sample size for the training set: Not applicable. This is not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary

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

September 3, 2015

Exactech, Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653

Re: K152170

Trade/Device Name: Exactech Optetrak Logic Enhanced Assembly Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: July 31, 2015 Received: August 4, 2015

Dear Mr. Hughes,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson -S

Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152170

Device Name Exactech Optetrak Logic Enhanced Assembly

Indications for Use (Describe)

Optetrak Logic Total Knee System:

Optetrak Logic CC Total Knee System:

The OPTETRAK Logic CC Total Knee System is indicated for cemented use only.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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Exactech® Optetrak Logic® Enhanced Assembly Special 510(k) - 510(k) Summary of Safety and Effectiveness

Sponsor:	Exactech, Inc.2320 N.W. 66th CourtGainesville, FL 32653
Phone:	(352) 377-1140
Fax:	(352) 378-2617
	FDA Establishment Number 1038671
Contact:	Patrick HughesSenior Regulatory Affairs Specialist
Date:	July 31, 2015

Trade or Proprietary or Model Name(s):

Exactech® Optetrak Logic® Total Knee System & Exactech® Optetrak Logic® CC Total Knee System

Common Name:

Cemented Total Knee Prosthesis

Classification Name:

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or Proprietary Model Name	Manufacturer
K093360	Optetrak Logic PS
K111400	Optetrak Logic CR, Sizes 1-5
K121307	Optetrak Logic CR, Sizes 0 & 6
K110547	Optetrak Logic PSC	Exactech, Inc
K123342	Optetrak Logic CRC
K132161	Optetrak Logic 17mm & 19mm Tibial Inserts
K150890	Optetrak Logic CC
K101981	Optetrak Logic Combo Trays

Indications for Use:

The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Comprehensive Knee Systems are indicated for cemented use only,

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Exactech® Optetrak Logic® Enhanced Assembly Special 510(k) - 510(k) Summary of Safety and Effectiveness

except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.

The Optetrak Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

The Optetrak Logic CC Total Knee System is indicated for cemented use only.

Device Description:

Testing Description:

This submission includes references to the following mechanical testing:

. Micromotion testing
Shear testing

Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic and Optetrak Logic CC devices are substantially equivalent to cited cleared predicate Optetrak Logic devices.

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.