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.

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

Device Description

The proposed Optetrak Logic. Total Knee System half-size finned and trapezoidal tibial trays are modifications to the existing Optetrak Total Knee System Cruciate Retained Titanium Back Tibial. Components (K932776) and Optetrak Total Knee Trapezoidal Cemented Tibial Components (933610), respectively. The proposed Optetrak Logic Total Knee System tibial inserts and femoral components are modifications to the existing Optetrak Total Knee System Hi-Fiex Knee Components (K033883).

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 .
similar design features .
. incorporate the same materials
the same shelf life .
. are packaged and sterilized using the same materials and processes.

AI/ML Overview

This document describes a 510(k) submission for the Exactech® Optetrak® Logic™ Total Knee System. 510(k) submissions, particularly for orthopedic implants like knee systems, typically rely on equivalence to predicate devices and engineering studies rather than clinical trials with human subjects to prove performance and safety. As such, the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies often does not apply in the context of a Special 510(k) for device modifications like this one.

Based on the provided text, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated in the provided text. For a device like this, acceptance criteria would typically involve demonstrating mechanical and material equivalence to the predicate devices through engineering studies (e.g., fatigue testing, wear testing, mechanical strength, dimensional conformity to design specifications). The reported device performance would be that it meets these criteria, thereby establishing substantial equivalence.

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

Not applicable in the context of this 510(k) Preamble. This submission is for modifications to an existing knee system and relies on engineering studies, not clinical trials with "test sets" of patients.

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

Not applicable. Ground truth as typically understood for diagnostic or AI-based devices (e.g., consensus of radiologists on images) is not relevant for this type of implantable device submission. The "ground truth" here would be the established performance characteristics and safety profile of the predicate devices, and the engineering principles demonstrating the modified device performs equivalently.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of patient data that would require medical expert adjudication in this type of submission.

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 implant, not an AI diagnostic or assistance tool, so MRMC studies are not relevant.

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

Not applicable. This device is a physical knee implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices through their prior clearances and long-term clinical use. The new device demonstrates "substantial equivalence" to these predicates. The types of evidence used to demonstrate this include:

Similar indications for use.
Similar design features.
Incorporation of the same materials.
Same shelf life.
Same packaging and sterilization processes.
Results of engineering studies. These studies would confirm that the modifications do not adversely affect the mechanical performance, wear characteristics, or other critical safety and performance attributes compared to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. There is no "training set" for this device.

Summary of the Study and Acceptance Criteria from the Provided Text:

The provided document is a 510(k) Summary of Safety and Effectiveness for a Special 510(k). This indicates that the device being submitted (Exactech® Optetrak® Logic™ Total Knee System) involves modifications to existing, already cleared predicate devices.

The core of the submission relies on demonstrating Substantial Equivalence to the predicate devices. The study proving this is explicitly mentioned as:

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

The "acceptance criteria" are therefore implicitly that the results of these engineering studies confirm the modified device maintains the same safety and effectiveness profile as the predicate devices, despite the modifications. The specific details of these engineering studies (e.g., fatigue tests, wear tests, material property analyses) and their numerical acceptance thresholds are not provided in this summary document but would be reviewed by the FDA as part of the full submission.

The document highlights the basis for substantial equivalence:

The same indications for use.
Similar design features.
Incorporate the same materials.
The same shelf life.
Are packaged and sterilized using the same materials and processes.

This document serves as a high-level summary, and the detailed engineering study reports would contain the specific acceptance criteria and detailed performance data.

Summary

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K093360 *1/2

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

Sponsor:	Exactech® Inc.2320 N.W. 66th CourtGainesville, FL 32653	JAN 1 1 2010
	Phone: (352) 377-1140Fax: (352) 378-2617
	FDA Establishment Number 1038671
Contact:	Patrick HughesRegulatory Affairs Specialist
Date:	January 6. 2010

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

Common Name:

Cemented Total Knee Prosthesis

Classification Name:

Knee joint patellofemorotibial polymer semi-constrained cemented cemented prosthesis

Information on devices to which Substantial equivalence is claimed:

510(k) Number	Trade or Proprietary or Model Name	Manufacturer
K933610	Optetrak Total Knee Trapezoidal CementedTibial Components	Exactech, Inc.
K932776	Optetrak Total Knee System CruciateRetained Titanium Back Tibial Components	Exactech, Inc.
K033883	Optetrak Total Knee System Hi-Flex KneeComponents	Exactech, Inc.
K933494	Optetrak Posterior Stabilized CementedTotal Knee	Exactech, Inc.
K032606	Optetrak Asymmetric Femoral Component	Exactech, Inc.

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K093360 #2/2

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

Indications for Use:

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 .
similar design features .
. incorporate the same materials
the same shelf life .
. are packaged and sterilized using the same materials and processes.

Substantial Equivalence Conclusion:

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

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Image /page/2/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 outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Exactech Inc. % Mr. Patrick Hughes 2320 N.W. 66th Court Gainesville, Florida 32653

JAN 1 1 2010

Re: K093360 Trade/Device Name: Exactech® Optetrak® Logic™ Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: December 09, 2009 Received: December 14, 4009

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.

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 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.

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Page 2 - Mr. Patrick Hughes

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.

Sincerely yours,

Barbara Buckner
for

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™ Total Knee System Special 510(k) - Indications for Use

510(k) Number: K093360

Device Name: Exactech® Optetrak® Logic™ Total 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, 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 Total Knee System is indicated for cemented use only.

Prescription Use(Part 21 CFR 801 Subpart D)	and/or	Over-The-Counter Use(21 CFR 807 Subpart C)
X

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Omuta for mxm

(Division Sign4 Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093360

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.