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

The proposed Optetrak Logic PSC Tibial Insert devices represent modifications to existing Optetrak Logic Total Knee System components (K093360). 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. The proposed Logic PSC devices combine the articulating geometry and locking features of predicate Optetrak Logic posterior stabilized inserts with a central spine that is slightly thicker in the medial/lateral dimensions, intended to provide surgeons with an option for treating patients with minor ligament laxity by introducing 2°-3° more varus/valgus constraint than the predicate.

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

. the same indications for use
. similar design features
. the same shelf life
are packaged and sterilized using the same materials and processes. .

AI/ML Overview

The provided content describes a medical device submission (Exactech® Optetrak® Logic™ PSC Tibial Insert Special 510(k)) and its path to clearance, not a study specifically designed to assess and report on acceptance criteria and device performance in the manner of AI/software or diagnostic devices.

Therefore, many of the requested points, such as sample sizes for test sets and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established for training, are not applicable to this submission as it focuses on demonstrating substantial equivalence for a physical medical implant through engineering and cadaveric assessments rather than clinical performance metrics in the way a diagnostic AI would be evaluated.

However, I can extract the information that is present and explain the type of study conducted within the context of demonstrating substantial equivalence for a medical device (knee implant insert) based on design modifications.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" here are implicitly related to the design and performance characteristics that ensure the modified device is substantially equivalent to the predicate device and safe/effective for its intended use. There are no explicit quantitative acceptance criteria defined as you might find for a diagnostic test. Instead, the "performance" is a demonstration of how the modified device maintains or improves upon the predicate's characteristics.

Evaluation Area	Activities Performed & "Acceptance Criteria" (Implicit)	Reported Device Performance
Logic PSC tibial spine shear strength	Implicit: Demonstrating shear strength is maintained or enhanced compared to predicate. Activities: Review of predicate designs for clinical performance and resistance to shear forces; Engineering drawing comparison of Logic PSC spine dimensions to predicate designs with successful clinical performance.	The summary concludes that "Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Optetrak Logic PSC Tibial Insert devices are substantially equivalent to cleared predicate Optetrak Logic posterior stabilized tibial insert devices." This implies the shear strength was found to be acceptable relative to the predicate.
Logic PSC/mating femoral component compatibility	Implicit: Ensuring proper fit and articulation. Activities: Cadaver laboratory assessment; Review of predicate designs for clinical performance; Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components.	Substantially equivalent to predicate, implying successful compatibility.
Logic PSC varus/valgus constraint	Implicit: Achieve desired 2°-3° more varus/valgus constraint while maintaining safety. Activities: Cadaver laboratory assessment; Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components.	Substantially equivalent to predicate, confirming the intended increased constraint is achieved and is acceptable.
Logic PSC internal/external constraint	Implicit: Maintaining appropriate internal/external constraint. Activities: Cadaver laboratory assessment; Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components.	Substantially equivalent to predicate, indicating acceptable internal/external constraint.
Logic PSC tibial spine/mating femoral component clearance	Implicit: Ensuring no impingement or adverse interaction. Activities: Review of predicate designs for clinical performance; Engineering drawing comparison of Logic PSC spine dimensions to predicate designs with successful clinical performance.	Substantially equivalent to predicate, implying adequate clearance.

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

Sample Size: Not explicitly stated as a number of "cases" or "patients."
- For cadaver evaluations, the sample size would be the number of cadaveric knees used, which is not disclosed in this summary.
- For engineering drawing comparisons, it would involve the design specifications of the proposed device and relevant predicate devices.
Data Provenance: The data comes from internal "engineering studies," "cadaver laboratory assessment," and a "review of predicate designs for clinical performance." This suggests a combination of prospective experimental testing (cadaver lab) and retrospective analysis (review of predicate clinical performance and engineering drawings). The country of origin of the data is not specified beyond being generated by Exactech® Inc. in Gainesville, Florida, USA.

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

This type of detail is not applicable or provided for this submission. The "ground truth" here is established by engineering principles, biomechanical testing (cadaver lab), and comparison to a legally marketed predicate device's design and known clinical history. There were no "experts" in the sense of clinicians establishing diagnostic ground truth on a set of patient data as might be found in an AI/diagnostic device study.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" in the sense of clinical cases requiring expert adjudication. The assessments were primarily engineering and biomechanical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where multiple human readers evaluate cases with and without AI assistance. This submission is for a physical medical implant.

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

Not applicable. There is no algorithm or AI component in this medical device submission.

7. The Type of Ground Truth Used

The "ground truth" is established through:
- Engineering specifications and measurements: Comparing dimensions and design features to ensure specific characteristics (e.g., spine thickness, clearances) and to assess compatibility.
- Biomechanical testing: Cadaver laboratory assessments to directly evaluate functionality such as varus/valgus constraint and compatibility.
- Predicate device's established safety and effectiveness: The underlying "ground truth" for demonstrating substantial equivalence is the prior legal marketing and presumably safe performance of the predicate device (Optetrak Logic Total Knee System K093360). The new device is shown to be similar in design and performance.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI device. The design (analogous to a "trained" entity) is based on existing engineering knowledge, predicate device designs, and biomechanical principles.

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

Not applicable. As there's no training set, there's no ground truth process for it. The "ground truth" for the design process would be established through established biomechanical principles, materials science, and the clinical outcomes/performance of previously cleared devices.

Summary

{0}------------------------------------------------

KI10547

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

APR 1 4 2011

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: April 8, 2011

Trade or Proprietary or Model Name(s):

Exactech® Optetrak® Logic™ PSC Tibial Insert

Common Name:

Cemented Total Knee Prosthesis

Classification Name:

21 CFR 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Class II.

Product Code: JWH - 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
	K093360	Optetrak Logic Total Knee System	Exactech, Inc

{1}------------------------------------------------

Exactech® Optetrak® Logic™ PSC Tibial Insert 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 proposed and predicate devices have the same intended use and basic fundamental scientific technology and share the following similarities:

. the same indications for use
. similar design features
. the same shelf life
are packaged and sterilized using the same materials and processes. .

{2}------------------------------------------------

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

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 PSC tibial spine shear strength	Review of predicate designs for clinical performance and resistance to shear forces Engineering drawing comparison of Logic PSC spine dimensions to predicate designs with successful clinical performance
Logic PSC/mating femoral component compatibility	Cadaver laboratory assessment Review of predicate designs for clinical performance Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components
Logic PSC varus/valgus constraint	Cadaver laboratory assessment Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components
Logic PSC internal/external constraint	Cadaver laboratory assessment Engineering drawing comparison of Logic PSC dimensions to predicate designs that successfully mate with the same components
Logic PSC tibial spine/mating femoral component clearance	Review of predicate designs for clinical performance Engineering drawing comparison of Logic PSC spine dimensions to predicate designs with successful clinical performance

Table 1: Optetrak Logic PSC Tibial Insert Performance Data

Substantial Equivalence Conclusion:

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

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with a serpent entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

Exactech, Inc. % Mr. Patrick Hughes Regulatory Affairs Specialist 2320 N.W. 66" Court Gainesville, Florida 32653

APR 1 4 2011

Re: K110547

Trade/Device Name: Exactech Optetrak Logic PSC Tibial Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 23, 2011 Received: March 24, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{4}------------------------------------------------

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/CDRH0ffices/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/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely, yours,

for

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

Enclosure

{5}------------------------------------------------

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

510(k) Number:

KI10547

Device Name: Exactech® Optetrak® Logic™ PSC Tibial Insert

INDICATIONS

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)

for M. Mielkeom

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Divisionomative Devices

510(k) Number K110547

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.