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 System is indicated for cemented use only.

Device Description

The proposed Optetrak Logic CRC Tibial Insert devices represent modifications to existing Optetrak Logic CR Knee System components cleared per 510(k) K111400 and 510(k) K121307. Both proposed and predicate devices are made from the same materials using the same processes and are compatible with the same Optetrak Logic tibial trays and femoral components.. Compared to predicate Logic CR inserts; the proposed Logic CRC inserts are designed to provide additional stability in the absence of a fully functioning PCL.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets it, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance (vs. predicate Logic CR inserts)
Anterior Constraint	Increased 54%
Posterior Constraint	Increased 14%
Overall Anterior-Posterior Constraint	Increased 34%
Medial-Lateral Constraint	Increased 6%
Rotational Constraint	Increased 33%
Substantial Equivalence	Demonstrated to be substantially equivalent to cleared predicate devices.

Note: The document only provides comparative performance against predicate devices, indicating the changes introduced by the new design. It doesn't define explicit pass/fail thresholds for each constraint measure as "acceptance criteria" but rather presents the observed increases as the performance that justifies equivalence. The ultimate acceptance criterion is the determination of "substantial equivalence" to the predicate.

Study Details

2. Sample Size and Data Provenance

Sample Size for Test Set: n=5 (This likely refers to the number of devices tested in the engineering study).
Data Provenance: Not explicitly stated beyond "engineering studies" and "cadaver lab testing." The engineering studies are likely laboratory tests conducted by the manufacturer. Cadaver lab testing would involve human cadavers.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

Number of Experts: Not explicitly stated, but referred to as "surgeon experts" (plural).
Qualifications of Experts: "Surgeon experts." Specific years of experience or specialty (e.g., orthopedic surgeon) are not provided.

4. Adjudication Method (Test Set)

Adjudication Method: Not specified. The document only states that "Devices were also evaluated by surgeon experts during cadaver lab testing." How their evaluations were combined or reconciled is not detailed.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. The document describes engineering studies and cadaver lab testing, not a comparative effectiveness study involving human readers (e.g., surgeons interpreting images with and without AI).

6. Standalone (Algorithm Only) Performance

Was a standalone study done? Not applicable. This device is a physical knee implant, not an algorithm or AI system. The "performance" relates to the mechanical properties of the device itself.

7. Type of Ground Truth Used

Type of Ground Truth:
- Engineering Study: Based on objective measurements according to ASTM F1223-08 to characterize constraint. The "ground truth" here is the measured mechanical output of the device under specific test conditions.
- Cadaver Lab Testing: Expert evaluation by surgeons. This would be based on clinical judgment and experience with the device in a simulated anatomical environment.

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The design was likely developed through iterative engineering and simulation, not "training" in the AI sense.

9. How Ground Truth for Training Set was Established

How Ground Truth was Established: Not applicable, as there is no "training set" in the context of this physical device. The design was likely refined based on engineering principles, biomechanical understanding, and potentially feedback from prior designs or clinical experience.

Summary

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Exactech® Optetrak Logic® CRC Tibial Insert Special 510(k) - 510(k) Summary of Safety and Effectiveness

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, FL 32653
Phone: (352) 327-4762 Fax: (352) 378-2617

FDA Establishment Number 1038671

Contact: Patrick Hughes Regulatory Affairs Specialist
Date: October 29, 2012

Trade or Proprietary or Model Name(s):

Exactech® Optetrak Logic® CRC Tibial Insert

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 or Model Name	Manufacturer
K111400	Optetrak Logic CR Knee System	Exactech, Inc
K121307	Optetrak Logic CR Knee System Sizes 0 and 6	Exactech, Inc

JAN 1 0 2013

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Exactech® Optetrak Logic® CRC Tibial Insert Special 510(k) - 510(k) Summary of Safety and Effectiveness

Indications for Use:

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

Device Description:

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

� Both made from ultra high molecular weight polyethylene per ASTM F648
. Both have the same indications for use
. Both have similar design features
. Both have the same shelf life
. Both are compatible with the same Logic devices
Both are packaged and sterilized using the same materials and processes .

Summary of Testing

Testing based on the methods detailed in ASTM F1223-08 was performed to characterize the amount of constraint introduced by the proposed dimensional changes (n=5). Compared to predicate Logic CR inserts, the results showed average Logic CRC anterior constraint increased 54%, average posterior constraint increased 14%, and average overall anterior-posterior constraint increased 34%. Average Logic CRC medial-lateral constraint increased 6% versus the predicate Logic CR devices, and average Logic CRC rotational constraint increased 33% over Logic CR. Devices were also evaluated by surgeon experts during cadaver lab testing.

Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Optetrak Logic CRC Tibial Insert devices are substantially equivalent to cleared predicate Optetrak Logic cruciate-retaining tibial insert devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure embracing another person, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: January 10, 2013

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

Re: K123342

Trade/Device Name: Exactech® Optetrak Logic® CRC Tibial Insert 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: December 10, 2012 Received: December 11, 2012

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 (reporting of medical

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Page 2 - Mr. Patrick Hughes

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/ucm]15809.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/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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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Exactech® Optetrak Logic® CRC Tibial Insert Special 510(k) - Indications for Use

K123342 510(k) Number:

Device Name: Exactech® Optetrak Logic® CRC Tibial Insert

INDICATIONS

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

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

2013.01.10 13:19:20

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

and/or

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices -- 05'00'

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.