The Optetrak Femoral components are intended to replace the patient's distal femur during primary or revision total knee arthroplasty. The Optetrak® Asymmetric Femoral components are intended for use when needed to more closely match the geometry of the patient's resected distal femur. This change results in separate components for the right and left knees. The Asymmetric, Cruciate-Retaining Cemented components and the Asymmetric, Cruciate-Retaining, Porous-Coated Femoral Components are intended for use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) is preserved.

The Optetrak® Size 6 Posterior-Stabilizing, Cemented Femoral Component and Asymmetric, Posterior-Stabilizing Femoral components are intended to replace the function of the PCL during a total knee arthroplasty in which the 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 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.

Device Description

The device modifications presented in this Special 510(k) represent changes to the posterior stabilized, cruciate-retaining cemented, and cruciate-retaining porous coated femoral components of the Optetrak® Total Knee System (K932690, K933494, K935726, K011976). These changes include:

Modification of the patellar flange to create an asymmetric femoral component
Addition of a larger size posterior-stabilized, cemented (symmetric) femoral component

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

The differences in design features between the proposed Optetrak AK Femoral and predicate Optetrak® Femoral include the following:

Changes to the anterior flange to make the component asymmetric by:
a. Tilting the flange laterally, and
b. Angling the proximal edge of the flange medially.
Adjustments to the patella groove edges by:
a. Increasing the edge radii resulting from the intersections of the patella groove and the trochlear condyles to smooth the edges, and
b. Slightly lowering the profile height of the medial trochlear condyle in the proximal area as a result of the tilting of the flange.

The difference in design between the proposed size 6 femoral component and the predicate femoral components consists of a size increase in the overall geometry of the component. resulting in:

An increase in the overall anterior-posterior dimension of four (4) millimeters
An increase in the overall medial-lateral dimension of five (5) millimeters

AI/ML Overview

The provided text describes a Special 510(k) submission for a line extension of the Exactech® Optetrak® Total Knee System, specifically for Optetrak® Femoral Components. This submission is for modifications to existing devices, not for a new medical imaging or diagnostic device that would involve an AI algorithm with specific acceptance criteria related to accuracy, sensitivity, or specificity.

Therefore, the document does not contain the information required to answer your request. The "acceptance criteria" discussed are related to demonstrating substantial equivalence to predicate devices for mechanical performance and design changes, rather than clinical performance metrics for an AI-powered diagnostic tool. The "study" mentioned refers to "Verification and Validation analyses" for implant performance, which are likely mechanical and design tests, not clinical studies with human participants, ground truth establishment, or statistical performance metrics.

Specifically, the following information is not present in the provided text:

A table of acceptance criteria and the reported device performance: The document does not specify quantitative clinical acceptance criteria or performance metrics in terms of accuracy, sensitivity, specificity, or similar.
Sample size used for the test set and the data provenance: No information about a clinical test set, its sample size, or data provenance is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as there is no clinical test set with an associated ground truth based on expert review.
Adjudication method for the test set: Not applicable.
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, as this is not an AI-powered diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

The sponsor and contact information (Exactech Inc.).
The device name and its classification.
The legally marketed predicate devices for substantial equivalence comparison.
The intended use, indications, and contraindications of the Optetrak Femoral components.
Specific device modifications:
- Modification of the patellar flange to create an asymmetric femoral component.
- Addition of a larger size posterior-stabilized, cemented (symmetric) femoral component.
A general statement about "PERFORMANCE DATA SUMMARY": "Verification and Validation analyses were conducted to verify that the implant performance would be adequate for anticipated in vivo loading." The conclusion is that the modified components are "substantially equivalent" to the predicate devices.

Summary

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KO32606

SEP 2 3 2003

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

Summary of Safety and Effectiveness

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

FDA Establishment Number: 1038671

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

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1032606

Exactech® Optetrak® Total Knee System Line Extension - Optetrak® Femoral 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 Name: · Asymmetric Femoral Components · Size 6 Posterior-Stabilizing, Cemented Femoral Component JWH Product Code: C.F.R. Section: 888.3560 II Device Class: Orthopedic Classification Panel:

Exactech® Legally Marketed Devices for Substantial Equivalence Comparison:

Model	510(k) Number
Optetrak® Cruciate Retaining Cemented Femoral Component	K932690
Optetrak® Posterior Stabilizing Cemented Femoral Component	K933494
Optetrak® Cruciate Retaining Porous-Coated Femoral Component	K935726
Optetrak® Size 0 and 1 Delta Line Extension	K011976

Device Information:

INTENDED USE

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2032606

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

Summary of Safety and Effectiveness

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

use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) is preserved.

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 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.

CAUTION: In the USA, for cemented use only.

Device Modifications

1. Modification of the patellar flange to create an asymmetric femoral component
1. Addition of a larger size posterior-stabilized, cemented (symmetric) femoral component

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

Summary of Safety and Effectiveness

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

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

Device Modifications - Optetrak® Asymmetric Femoral Components (Optetrak® AK):

The differences in design features between the proposed Optetrak AK Femoral and predicate Optetrak® Femoral include the following:

1. Changes to the anterior flange to make the component asymmetric by:
- a. Tilting the flange laterally, and
- b. Angling the proximal edge of the flange medially.
1. Adjustments to the patella groove edges by:
- a. Increasing the edge radii resulting from the intersections of the patella groove and the trochlear condyles to smooth the edges, and
- b. Slightly lowering the profile height of the medial trochlear condyle in the proximal area as a result of the tilting of the flange.

Device Modifications - Optetrak® Size 6 Posterior-Stabilized, Cemented Femoral Component:

The difference in design between the proposed size 6 femoral component and the predicate femoral components consists of a size increase in the overall geometry of the component. resulting in:

1. An increase in the overall anterior-posterior dimension of four (4) millimeters
1. An increase in the overall medial-lateral dimension of five (5) millimeters

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® Asymmetric Femoral Components and the Size 6 Posterior-Stabilizing Cemented Femoral Component are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak® femoral components.

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Image /page/4/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text is partially obscured but appears to read "HEALTH & HUMAN SERVICES - USA". The bird-like symbol consists of three curved lines that resemble wings or feathers, creating a sense of movement or flight. The logo is in black and white and has a slightly distressed or aged appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2003

Mr. Martin Sprunck Regulatory Representative Exactech, Inc. 2320 N.W. 66th Court Gainesville, FL 32653

Re: K032606

Trade/Device Name: OPTETRAK® 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: August 20, 2003 Received: August 25, 2003

Dear Mr. Sprunck:

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 lisuing (21 CFR Part 807); labeling (21 CFR Part 801); 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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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 A. Melkerson

'elia 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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Image /page/6/Picture/0 description: The image shows a handwritten alphanumeric string. The string is 'K032606'. The characters are written in a simple, slightly slanted style, with each character clearly distinguishable.

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

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

510(k) Number:

032606

Device Name:

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 degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

CONTRAINDICATIONS

CAUTION: In the USA, for cemented use only.

Mark A. Mellem

Division of General, I morative and Neurological Devi.es

510(k) Numl er

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use

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.