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. CAUTION: For cemented use only in the USA.

Device Description

The proposed Optetrak Line Extension (Size 0) femoral components are composed of Cobalt Chromium alloy (ASTM F-75). The proposed Size 0 femoral component is available in the cruciate retaining (CR) and posterior stabilized (PS) styles. The design incorporates the same design features as the predicate Optetrak femoral components on a smaller scale. The existing Optetrak patellar components (#K932690) are fully compatible with the proposed Optetrak Line Extension (Size 0) femoral components. The proposed Line Extension (Size 0 and 1 Delta) tibial inserts are composed of Ultra High Molecular Weight Polyethylene - UHMWPE (ASTM F648). The proposed insert components for the Size 0 are available in the cruciate retaining (CR) and posterior stabilized (PS) styles, similar to those in the existing Optetrak system. The proposed insert components for the Size 1 Delta are available in cruciate retaining (CR), posterior stabilized (PS), and constrained condylar (CC) styles, similar to those in the existing Optetrak system. The predicate and proposed models have the same locking mechanism . for assembly of the polymer insert into the tibial trav. In addition, the CC spine stiffener screw line has been expanded to accommodate the Size 1 Delta CC tibial inserts. This screw acts as a stabilizing force in the spine of the CC tibial insert. The screw varies in length according to tibial insert thickness and is packaged with the appropriate insert. Optetrak Line Extension (Size 0 and 1 Delta) tibial tray components are designed to accept the modular tibial insert (described above). The proposed tibial tray components are composed of Titanium alloy (Ti 6A1 4 V), which is the same as the predicate Optetrak trays. The locking mechanism is identical to that of the predicate Optetrak system. Similarly, the proposed line extension offers a finned stem tray version and a trapezoid stem tray version. Both designs have tibial component options that allow for upsizing and downsizing on the tibia. The proposed Optetrak Line Extension (Size 0 and 1 Delta) tibial augment components are designed to work with their corresponding Size 0 and 1 Delta trapezoid tibial trays. The components are composed of Titanium alloy (Ti 6 Al 4V) conforming to ASTM F136.

AI/ML Overview

The provided document is a 510(k) summary for the Exactech Optetrak Total Knee System Size 0/1 Delta. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the way a novel device might.

Therefore, the information you've requested regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment from a new study is not available in this document. The submission relies on "performance data" in the form of "design assurance reviews" to verifiy that the implant performance would be adequate by comparing to predicate devices.

Here's an explanation based on the provided text:

Based on the provided K011976 document for the Exactech Optetrak Total Knee System Size 0/1 Delta:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of explicit acceptance criteria or specific numeric device performance metrics from a new study. Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices.

The "performance data" section states:
"Design assurance reviews were conducted to verify that the implant performance would be adequate for anticipated in vivo loading. These activities did not indicate the need for additional testing beyond that performed for validation of the previously mentioned predicate Optetrak models."

This indicates that the acceptance criteria implicitly align with the performance standards and safety profiles established for the predicate devices. The reported device performance is therefore deemed to be equivalent to these predicate devices.

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

No explicit test set sample size is mentioned, as no new clinical study with a dedicated test set was conducted for this 510(k) submission. The assessment was based on design assurance reviews relative to predicate devices.

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

Not applicable, as no new test set requiring expert ground truth establishment was used for this submission.

4. Adjudication Method for the Test Set:

Not applicable, as no new test set was used.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) submission. This type of study would typically assess the improvement of human readers with AI assistance, which is outside the scope of this device submission for a knee prosthesis.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not conducted or described. This term typically applies to AI/software as a medical device (SaMD), not a knee prosthesis.

7. Type of Ground Truth Used:

The "ground truth" for the assessment of this device is implicitly the established safety and effectiveness profile of the predicate devices to which it is compared. The design assurance reviews aimed to confirm that the new device's design, materials, and intended use aligned with these established standards.

8. Sample Size for the Training Set:

Not applicable. As this is a physical medical device (knee prosthesis) and not an AI/ML algorithm, there is no "training set" in the conventional sense of machine learning.

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

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

Summary

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K011976

2320 NW 66TH COUR GAINESVILLE, FL 3265

352-377-1140 FAX 352-378-2617

JUL 1 6 2001

Exactech® Optetrak ™ Total Knee System Size 0 / 1 Delta Line Extension

510(k) Summary of Safety and Effectiveness Special 510(k)

Sponsor:

Exactech® Inc. 2320 N.W. 66th Court Gainesville, Florida 32653

Phone:	(352) - 377 - 1140
Fax:	(352) - 378 - 2617

FDA Establishment Number 1038671

Contact: Gary J. Miller, Ph.D. V.P. of Research and Development

Date:

June 13, 2001

Section 4 Page 1 of 5

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510(k) Summary of Safety and Effectiveness Special 510(k)

Classifications / Proprietary Names:

Classification Name:

Prosthesis, knee, patellofemorotibial, semi-contrained, cemented, polymer/metal polymer

Trade / Proprietary Model Names:

Optetrak Total Knee System Size 0 / 1 Delta

JWH Product Code: C.F.R. Section: 888.3560

Device Class: II

Classification Panel: Orthopedic

Legally Marketed Devices for Substantial Equivalence Comparison:

Exactech Predicate Devices
Model	Manufacturer	510(k) Number
Optetrak CR Femoral	Exactech	#K932690
Optetrak PS Femoral	Exactech	#K933494
Optetrak Porous CR Femoral	Exactech	#K935726
Optetrak PS Tibial Insert	Exactech	#K933610
Optetrak CR Tibial Insert	Exactech	#K932776
Optetrak CC Tibial Insert	Exactech	#K954208
Optetrak Finned Tibial Tray	Exactech	#K932776
Optetrak Finned Porous Tibial Tray	Exactech	#K936079
Optetrak Trapezoidal Tibial Tray	Exactech	#K933610
Optetrak Tibial Augments	Exactech	#K933610

Predicate Devices from other Manufacturers

Nexgen	Zimmer	----------
Maxim	Biomet	----------
PFC	Johnson & Johnson	----------

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510(k) Summary of Safety and Effectiveness Special 510(k)

Device Information:

INDICATIONS

CAUTION: For cemented use only in the USA.

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.

DEVICE DESCRIPTION

Femoral Components

Tibial Components

The proposed Line Extension (Size 0 and 1 Delta) tibial inserts are composed of Ultra High Molecular Weight Polyethylene - UHMWPE (ASTM F648). The proposed insert components for the Size 0 are available in the cruciate retaining (CR) and posterior stabilized (PS) styles, similar to those in the existing Optetrak system. The proposed insert components for the Size 1 Delta are available in cruciate retaining (CR), posterior stabilized (PS), and constrained condylar (CC) styles, similar to those in the existing Optetrak system. The predicate and proposed models have the same locking mechanism . for assembly of the polymer insert into the tibial trav.

Section 4 Page 3 of 5

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510(k) Summary of Safety and Effectiveness Special 510(k)

In addition, the CC spine stiffener screw line has been expanded to accommodate the Size 1 Delta CC tibial inserts. This screw acts as a stabilizing force in the spine of the CC tibial insert. The screw varies in length according to tibial insert thickness and is packaged with the appropriate insert.

Tibial Tray Components

Optetrak Line Extension (Size 0 and 1 Delta) tibial tray components are designed to accept the modular tibial insert (described above). The proposed tibial tray components are composed of Titanium alloy (Ti 6A1 4 V), which is the same as the predicate Optetrak trays. The locking mechanism is identical to that of the predicate Optetrak system. Similarly, the proposed line extension offers a finned stem tray version and a trapezoid stem tray version. Both designs have tibial component options that allow for upsizing and downsizing on the tibia.

Augmentation Components

The proposed Optetrak Line Extension (Size 0 and 1 Delta) tibial augment components are designed to work with their corresponding Size 0 and 1 Delta trapezoid tibial trays. The components are composed of Titanium alloy (Ti 6 Al 4V) conforming to ASTM F136.

Material	Composition
Inner / Outer Trays	PETG - 0.040" thickness
Tray Lids	Spun-Bonded Olefin - Tyvek®
Inserts	Medium grade LD45 Foam
Box	Heavy weight cardboard
Outer Shrink-Wrap	Clear, Light-Weight Plastic
Shipping Cartons	Heavy-weight Corrugated Cardboard

PACKAGING MATERIALS

STERILIZATION INFORMATION

Method: Gamma radiation (Cobalt 60 source) Dose: 25 - 37 kGy Sterility Assurance Level (SAL): 10-6

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510(k) Summary of Safety and Effectiveness Special 510(k)

PERFORMANCE DATA

Design assurance reviews were conducted to verify that the implant performance would be adequate for anticipated in vivo loading. These activities did not indicate the need for additional testing beyond that performed for validation of the previously mentioned predicate Optetrak models.

We conclude that the Optetrak Size 0 / 1 Delta components are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak products.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 6 2001

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

Re: K011976

Trade Name: Optetrak Total Knee System Size 0/1 Delta Regulation Number: 888.3560 Regulatory Class: II Product Code: JWH Dated: June 21, 2001 Received: June 25, 2001

Dear Dr. Miller:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through perrodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{6}------------------------------------------------

Page 2 - Gary J. Miller, Ph.D.

This letter will allow you to begin marketing your device as described in your - 10kk) premarket I his letter will anow you to begin marketing your arence of your device to a legally marketed notification. The IDA intimation of substantial equal device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your actives on our can research the Office of Compliance at additionally 809.10 for mi vitio diagnostions on the promotion and advertising of your device, (301) 594-4039. Additionally, for quest 213-01) 594-4639. Also, please note the regulation please contact the Office of Compilance at (301) of CFR 807.97). Other general entitled, "Misoranding by relected to premation news be obtained from the Division of Small
information on your responsibilities under the Act may 1901) 142, 6507 and information on your responsibilities and in 1991 million (800) 638-2041 or at its Manufacturers "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Mark N-Mullinson

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® Optetrak Total Knee System Size 0 / 1 Delta

Indications for Use

510(k) Number:

K011976

Device Name:

Optetrak Total Knee System Size 0 / 1 Delta

INDICATIONS

CAUTION: For cemented use only in the USA.

CONTRAINDICATIONS

Mark n Milkeran

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation7(ODE)

Prescription Use

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Over the Counter Use

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.