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 Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.

Device Description

Optetrak Advanced Patella implants represent dimensional modifications to "classic" Optetrak patella components. Like the predicate devices, Optetrak Advanced Patella implants are intended for resurfacing the patella during tri-compartmental total knee arthroplasty with other Optetrak and Optetrak Logic components. Optetrak Advanced Patella implants are designed to provide expanded options to help surgeons optimize bone coverage while keeping the same basic features and device compatibility as predicate "classic" Optetrak patella implants.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA regarding the Exactech Optetrak Advanced Patella device. It is a notification for a medical device, not an AI/ML device, therefore the information requested about acceptance criteria and studies (sample size, data provenance, expert numbers, adjudication, MRMC, standalone, ground truth, training set) is not applicable to this document.

The document discusses the substantial equivalence of the new device to a legally marketed predicate device, primarily based on design and material similarities, and mechanical testing.

Here's what information is available that partially relates to "acceptance criteria" and "study":

1. A table of acceptance criteria and the reported device performance:

The document doesn't provide a formal table of quantitative acceptance criteria as would be expected for an AI/ML model's performance metrics (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" can be inferred as demonstrating that the new device does not introduce a new worst-case scenario compared to the predicate device in terms of mechanical performance.

Acceptance Criteria (Inferred)	Reported Device Performance
Patellofemoral contact pressure is not a new worst-case	Reported results show the Optetrak Advanced Patella Devices do not represent a new worst-case (compared to predicate) in patellofemoral contact pressure analysis.
Substantial equivalence to predicate device in technological characteristics	The device is an orthopedic implant made from ultra-high molecular weight polyethylene. It features the same spherical articulating geometry, mating device congruence, and bone-apposing fixation features as other Optetrak patella implants. It also has similar product scope, an increased medial-lateral area, and an asymmetric "avocado"-shaped perimeter, intended for cemented fixation. These characteristics are compared to the predicate.

Acceptance Criteria (Inferred)

Reported Device Performance

Patellofemoral contact pressure is not a new worst-case

Reported results show the Optetrak Advanced Patella Devices do not represent a new worst-case (compared to predicate) in patellofemoral contact pressure analysis.

Substantial equivalence to predicate device in technological characteristics

The device is an orthopedic implant made from ultra-high molecular weight polyethylene. It features the same spherical articulating geometry, mating device congruence, and bone-apposing fixation features as other Optetrak patella implants. It also has similar product scope, an increased medial-lateral area, and an asymmetric "avocado"-shaped perimeter, intended for cemented fixation. These characteristics are compared to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This is a mechanical device, and the "test set" refers to mechanical testing, not a dataset of patient images or information. The testing conducted is described as "engineering studies."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. Ground truth, in this context, would involve objective measurements from mechanical testing performed by engineers/technicians, not expert consensus as in AI/ML validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers or annotators in AI/ML studies. This is not relevant to mechanical testing.

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 an orthopedic implant, not an AI system. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable. This refers to AI algorithm performance.

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

For the mechanical testing, the "ground truth" would be the direct measurements and physical properties observed during the engineering studies (e.g., contact pressure values). There is no "expert consensus" or "pathology" in this context.

8. The sample size for the training set:

Not applicable. There is no AI model or training set for this medical device submission.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set.

Summary

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

March 18, 2016

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

Re: K160484 Trade/Device Name: Optetrak Advanced Patella 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: February 17, 2016 Received: February 22, 2016

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K160484

Device Name Optetrak Advanced Patella

Indications for Use (Describe)

The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Comprehensive Knee Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.

Type of Use (Select one or both , as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Exactech® Optetrak® Advanced Patella Special 510(k) - 510(k) Summary of Safety and Effectiveness

Sponsor:	Exactech, Inc.2320 N.W. 66th CourtGainesville, FL 32653
	Phone: (352) 377-1140Fax: (352) 378-2617
	FDA Establishment Number 1038671
Contact:	Patrick HughesSenior Regulatory Affairs Specialist
Date:	February 18, 2016

Trade or Proprietary or Model Name(s):

Exactech® Optetrak® Advanced Patella

Common Name: Cemented Total Knee Prosthesis

Classification Name: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Classification Panel: Orthopedic

Product Code: JWH

Regulation Number 888.3560

Device Class II

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or Proprietary Model Name	Manufacturer
K954208	Optetrak Constrained Condylar Knee	Exactech, Inc

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Exactech® Optetrak® Advanced Patella Special 510(k) - 510(k) Summary of Safety and Effectiveness

Indications for Use:

Device Description:

Technological Characteristics

The Optetrak Advanced Patella is an orthopedic implant made from ultra-high molecular weight polyethylene. It features the same spherical articulating geometry, mating device congruence, and bone-apposing fixation features as other Optetrak patella implants, and is provided in a similar product scope. Where other Optetrak patella components are circular, the Optetrak Advanced Patella features an increase in medial-lateral area relative to the proximal-distal aspect on the bone-apposing face of the implant and an asymmetric, "avocado"-shaped perimeter. Like other Optetrak patella implants, the Optetrak Advanced Patella is intended for cemented fixation.

Testing Description:

This submission reports results for the following mechanical testing:

o Patellofemoral contact pressure analysis
Reported results show the Optetrak Advanced Patella Devices do not represent a new worst-case

Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate proposed Optetrak Advanced Patella devices are substantially equivalent to cited cleared predicate Optetrak patella components.

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.