The Optetrak Logic 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.

In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.

Device Description

Proposed Optetrak Logic CR Knee System femoral components are modifications to existing femoral components cleared per Optetrak Cruciate Retaining Cemented Total Knee System 510(k) #K932690 and Optetrak Logic Total Knee System 510(k) #K093360.

Proposed Optetrak Logic CR Knee System tibial inserts are modifications to existing tibial inserts cleared per Optetrak Cruciate Retaining Cemented Total Knee System 510(k) #K932690 and Optetrak CR Slope 510(k) #K082022.

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 design features .
. the same materials
the same shelf life .
. packaging and sterilization using the same materials and processes
compatible with the same corresponding Optetrak tibial trays ●

The Optetrak Logic CR Knee System is not being submitted as the result of a recall or any corrective action related to the Optetrak product lines.

AI/ML Overview

The provided document describes the Exactech® Optetrak® Logic® CR Knee System, a cemented total knee prosthesis. The submission is a Special 510(k) and focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable format with pass/fail thresholds. Instead, the performance evaluations are centered around demonstrating substantial equivalence to existing predicate devices. The "performance data" table describes the activities performed to support this claim.

Evaluation Area	Activities Performed	Reported Device Performance/Conclusion
Logic CR insert/femoral component compatibility	Engineering drawing comparison to mating components and equivalent predicates	"Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CR Knee System devices are substantially equivalent to cited cleared predicate devices." (Implied: compatible with mating components)
Logic CR insert/tibial tray compatibility	Engineering drawing comparison to mating components and equivalent predicates	"Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CR Knee System devices are substantially equivalent to cited cleared predicate devices." (Implied: compatible with mating components)
Tibial insert scope addition mechanical properties	Engineering evaluation using Finite Element Analysis to compare contact stresses with predicates	"Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CR Knee System devices are substantially equivalent to cited cleared predicate devices." (Implied: comparable mechanical properties)
Femoral component scope addition equivalency	Engineering drawing comparison to mating components and equivalent predicates	"Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CR Knee System devices are substantially equivalent to cited cleared predicate devices." (Implied: equivalent design)
Femoral component design modification	Engineering evaluation using Finite Element Analysis to compare contact stresses with predicates	"Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Logic CR Knee System devices are substantially equivalent to cited cleared predicate devices." (Implied: comparable mechanical properties)

The overall acceptance criterion is based on demonstrating substantial equivalence to the predicate devices. The reported "performance" is that the results of the engineering studies demonstrate substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

The document describes engineering evaluations (drawing comparisons and Finite Element Analysis), not a test set in the traditional sense of human subjects or clinical data. Therefore, there is no sample size for a test set, nor is there information on data provenance (country of origin, retrospective/prospective) as these evaluations are based on design specifications and simulation, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

No experts were used to establish ground truth in the context of a test set, as the evaluations were engineering-based rather than involving diagnostic interpretation or clinical outcomes. The "experts" in this context would be the engineers performing the drawing comparisons and finite element analysis, but their qualifications and numbers are not specified.

4. Adjudication Method for the Test Set

Not applicable. There was no test set requiring adjudication in the medical or clinical sense. The comparisons and analyses are engineering-based.

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 device is a knee prosthesis, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI-related improvement metrics are irrelevant to this submission.

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

Not applicable. This device is a physical medical implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" in this context is the design specifications and performance characteristics of the predicate devices. The new device's design, compatibility, and mechanical properties were compared against these established predicates to demonstrate equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Exactech® Optetrak® Logic® CR Knee System Special 510(k) - 510(k) Summary of Safety and Effectiveness

JUL 2 8 2011

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

e, FL 32655

(352) 377-1140

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

FDA Establishment Number 1038671

Contact: Patrick Hughes Regulatory Affairs Specialist
May 17, 2011 Date:

Trade or Proprietary or Model Name(s): Exactech® Optetrak® Logic® CR Knee System

Common Name: Cemented Total Knee Prosthesis

Classification Name:

21 CFR 888.3560 - Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis.

Product Code: JWH - prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

FDA Classification: Class II

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or Proprietary or Model Name	Manufacturer
K932690	Optetrak Cruciate Retaining Cemented Total Knee System	Exactech, Inc.
K093360	Optetrak Logic Total Knee System	Exactech, Inc.
K082022	Optetrak CR Slope	Exactech, Inc.

: ', '

KIILOD

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Exactech® Optetrak® Logic® CR Knee System Special 510(k) - 510(k) Summary of Safety and Effectiveness

Indications for Use:

In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.

Device Description:

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 design features .
. the same materials
the same shelf life .
. packaging and sterilization using the same materials and processes
compatible with the same corresponding Optetrak tibial trays ●

The Optetrak Logic CR Knee System is not being submitted as the result of a recall or any corrective action related to the Optetrak product lines.

Performance Data

Table 1 shows performance data provided, cited, or referenced in this submission to support a conclusion of substantial equivalence:

Evaluation	Activities Performed
Logic CR insert/femoral componentcompatibility	Engineering drawing comparison to mating components and equivalentpredicates
Logic CR insert/tibial traycompatibility	Engineering drawing comparison to mating components and equivalentpredicates
Tibial insert scope additionmechanical properties	Engineering evaluation using Finite Element Analysis to compare contactstresses with predicates
Femoral component scope additionequivalency	Engineering drawing comparison to mating components and equivalentpredicates
Femoral component designmodification	Engineering evaluation using Finite Element Analysis to compare contactstresses with predicates

Table 1: Optetrak Logic CR Performance Data

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Exactech® Optetrak® Logic® CR Knee System Special 510(k) - 510(k) Summary of Safety and Effectiveness

Substantial Equivalence Conclusion:

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

KI|1400 Page 3 of 3

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an abstract human figure with three flowing lines, positioned to the right. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

Exactech, Inc. % Mr. Patrick Hughes Re1g4ulatory Affairs Specialist 2320 NW 66" Court Gainesville, Florida 32653

JUL 28 2011

Re: K111400

Trade/Device Name: Exactech® Optetrak® Logic® CR Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JWH Dated: July 18, 2011 Received: July 20, 2011

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

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Page 2 - Mr. Patrick Hughes

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/ReportalProblem/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.

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

Sincerely yours,

Mark M. Milkerson

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® Optetrak® Logic® CR Knee System Special 510(k) - Indications for Use

510(k) Number:	K111400
----------------	---------

Device Name: Exactech® Optetrak® Logic® CR Knee System

INDICATIONS

The OPTETRAK Logic 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 revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

In the USA, the OPTETRAK Logic Total Knee System is indicated for cemented use only.

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

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)

tor m. melkerson

(Division Sign Off) (Division Sign Off)
Division of Surgical, Orthopedic, Orthopedic, Devices Division ODSurgious, and Restorative Devices

510(k) Number R111400

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.