The Optetrak® HI-FLEX Asymmetric Posterior-Stabilized Cemented Femoral Components (herein referred to as the Optetrak® HI-FLEX PS Femoral Components) and Optetrak® HI-FLEX Posterior-Stabilized Tibial Inscrts (Herein referred to as the HI-FLEX PS Tibial Inserts) are intended to be used with an Optetrak® Tibial Tray to replace the patient's distal fomur and proximal tibia during primary or revision total knee arthroplasty. The Optetrak® HI-FLEX PS Femoral components are intended for use when needed to closely match the geometry of the patient's resected distal femur and allows for more flexion than the standard Optetrak® components.

The Optetrak® HI-FLEX PS Tibial Insert is intended for use with the Optetrak® HI-FLEX PS Femoral components to afford the patient a higher degree of flexion than the standard Optetrak " femoral/tibial insert combination.

The proposed components are intended for use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) must be sacrificed.

All proposed femoral components are intended for cemented use only.

The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knce replacement due to osteoarthritis, osteonecrosis, theurnatoid 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.

Device Description

The device modifications to the femoral components presented in this Special 510(k) represent changes to the Optetrak® Asymmetric (AK), Posterior-Stabilized, Cemented Femoral Components (K032606) and the Optetrak® B-Series Postcrior-Stabilized Femoral Component (K010434). These changes represent a combination of

The condyle, anterior cam, asymmetric flange and PCL stabilizing box geometries of the Optetrak® AK Femoral components, and
The Posterior condyle radius and cam geometries of the Optetrak® B-Series Femoral Component

The device modifications to the tibial insert components presented in this Special 510(k) represent changes to the Optetrak® Posterior-Stabilized Tibial Inserts (K011976 and K933610) and changes to the Optetrak® B-scries Tibial Inserts (K010434). These changes represent a combination of:

The articulating surfaces, mating geometry and anterior spine geometry of the Optetrak® Posterior-Stabilized Tibial Inscrts, and
The posterior portion of the spine and the posterior scallops of the Optetrak® B-Series Tibial Insert Component

No changes were made to the patellar or tibial tray components of the Optetrak® Total Knec System.

AI/ML Overview

The Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components is a medical device. The provided text is a 510(k) premarket notification for this device, outlining its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are based on demonstrating substantial equivalence to legally marketed predicate devices. The performance data presented focuses on verifying the implant's mechanical adequacy for anticipated in vivo loading.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Devices (functionality, safety, basic technology)	The Optetrak® Hi-FLEX PS Femoral Components and the Optetrak® Hi-FLEX PS Tibial Inserts are concluded to be substantially equivalent to Exactech's predicate Optetrak® AK Femoral and Optetrak® Posterior-Stabilized tibial insert.
Adequate Implant Performance for Anticipated In Vivo Loading	Verification and Validation analyses were conducted to verify that the implant performance would be adequate for anticipated in vivo loading.
Indications for Use	Identical to predicate device.
Contraindications	Identical to predicate device.
Materials	(Implied to be same as predicate, as no material changes are mentioned in relation to the new components; the focus is on geometry modifications).*

Note: While not explicitly stated as "acceptance criteria," these are the aspects evaluated for a 510(k) submission to demonstrate that the new device is as safe and effective as a legally marketed device.

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

The document does not specify a "test set" in the context of clinical data or patient outcomes for this 510(k) submission. The performance assessment primarily relies on "Verification and Validation analyses" which are typically engineering tests, mechanical simulations, and material characterizations.

Sample Size for Test Set: Not applicable as no clinical test set data is described. The "sample" would refer to the components tested in engineering analyses. The specific number of components or iterations for these tests is not provided in the summary.
Data Provenance: Not applicable for clinical data. For the engineering analyses, the provenance would be internal to Exactech, likely conducted in a laboratory setting. The country of origin of such data is not specified but presumed to be the USA where Exactech is located. The study is a retrospective analysis of the design modifications and their compliance with established engineering and manufacturing standards, as opposed to a prospective clinical trial.

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

Not applicable. This 510(k) submission is for a line extension of an orthopedic implant, focusing on mechanical performance and substantial equivalence, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" for mechanical performance would be established by engineering specifications, material properties, and biomechanical standards, not by expert consensus on clinical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set involving human interpretation that would require an adjudication method.

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 (hardware), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on engineering specifications, biomechanical testing standards, material science principles, and comparison to the established performance of predicate devices. The verification and validation analyses would have used these objective measures to confirm the safety and performance of the modified components.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As there is no "training set" for an AI model, the concept of establishing ground truth for it does not apply.

Summary

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K033883

FEB 1 3 2004

Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components Special 510(k)

Summary of Safety and Effectiveness

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Exactech® Inc. Sponsor: 2320 N.W. 66th Court Gainesville, Florida 32653 (352) 377-1140 Phonc: (352) 378-2617 Fax:

FDA Establishment Number: 1038671

Contact: Dr. Gary Miller Vice President of Research and Development
Date:

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Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components Special 510(k)

Summary of Safety and Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Classifications / Proprietary Names: Prosthesis, Knee, Patellofemorotibial, Semi-Classification Name: Constrained, cemented, Polymer/Metal/Polymer Optetrak® Total Knee System Trade / Proprietary Model Namc: · HI-FLEX Asymmetric Posterior-Stabilized Cemented Femoral Components · HI-FLEX Posterior-Stabilized Tibial Insert Components JWH Product Code: 888.3560 C.F.R. Section: II Device Class: Orthopedic Classification Panel:

Exactech Legally Marketed Devices for Substantial Equivalence Comparison:

Model	510(k) Number
Optetrak® Total Knee System Tibial Component	K933610
Optetrak® Size 0 and 1 Delta Line Extension	K011976
Optetrak® Total Knee Asymmetric Femoral Components	K032606
Optetrak® B-Series Total Knee System	K010434

Device Information:

INTENDED USE

Section 4 Page 2 of 4

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Summary of Safety and Effectiveness

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match the geometry of the patient's resected distal femur and allows for more flexion than the standard Optetrak® components.

The proposed components are intended for use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) must be sacrificed.

All proposed femoral components are intended for cemented use only.

INDICATIONS

CONTRAINDICATIONS

The OPTETRAK® Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate inscrtion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, and in patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

Optctrak® HI-FLEX Tibial Inserts must be used with Optetrak® HI-FLEX Femoral Components.

CAUTION: In the USA, for cemented use only.

Device Modifications

The device modifications to the femoral components presented in this Special 510(k) represent changes to the Optetrak® Asymmetric (AK), Posterior-Stabilized, Cemented

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Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components Special 510(k)

Summary of Safety and Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Femoral Components (K032606) and the Optetrak® B-Series Postcrior-Stabilized Femoral Component (K010434). These changes represent a combination of

1. The condyle, anterior cam, asymmetric flange and PCL stabilizing box geometries of the Optetrak® AK Femoral components, and
1. The Posterior condyle radius and cam geometries of the Optetrak® B-Series Femoral Component

1. The articulating surfaces, mating geometry and anterior spine geometry of the Optetrak® Posterior-Stabilized Tibial Inscrts, and
1. The posterior portion of the spine and the posterior scallops of the Optetrak® B-Series Tibial Insert Component

No changes were made to the patellar or tibial tray components of the Optetrak® Total Knec System.

PERFORMANCE DATA SUMMARY

Verification and Validation analyses were conducted to verify that the implant performance would be adequate for anticipated in vivo loading.

We conclude that the Optetrak® Hi-FLEX PS Femoral Components and the Optetrak® Hi-FLEX PS Tibial Inserts are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak® AK Femoral and Optetrak® Posterior-Stabilized tibial insert.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The symbol is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2004

Gary J. Miller, Ph.D. Vice President of Research and Development Exactech, Inc. 2320 N.W. 66th Court Gainesville, Florida 32653

Rc: K033883 Trade/Device Name: Optetrak® Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: January 15, 2004 Received: January 16, 2004

Dear Dr. Miller:

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 such 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); good manufacturing practice requirements as sct 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 - Gary J. Miller, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely, yours,

Mark M. Milkerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exactech

2320 NW 66TH COU GAINFSVILLE, FL 326

Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components Special 510(k)

352 377-1140 FAX 352-378-2617

Indications for Use

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

510(k) Number: #K033883

Device Name: Optetrak® Total Knce System

. HI-FLEX Asymmetric Posterior-Stabilized Cemented Femoral Components
HI-FLEX Posterior-Stabilized Tibial Insert Components .

INDICATIONS

The OPTETRAK® Total 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 degencrative problems. They arc also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

CONTRAINDICATIONS

The OPTETRAK® Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, and in patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

OPTETRAK® HI-FLEX Tibial Inserts must be used with Optetrak® HI-FLEX Femoral Components.

CAUTION: In the USA, for cemented use only.

Prescription Use (Part 21 CFR 801 D)

Over the C

Over the Counter Use

Mud. A. Millers
Division Sign Off

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

e of CDRH, Office of Device Evaluation (ODE)

510(k) Number K033883

Section 3 Page 1 of 1

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.