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.

Device Description

One Logic femoral components are part of the Optetrak / Optetrak Logic device family and are for use in resurfacing femoral bone as part of tri-compartmental total knee arthroplasty employing modular components.

Cemented One Logic PS femoral components represent modifications to Optetrak Logic Total Knee System femoral components cleared per 510(k) submission K093360. Proposed cemented One Logic CR femoral components represent modifications to Optetrak Logic CR femoral components cleared per 510(k) submissions K111400 and K121307.

Porous-coated PS and CR One Logic femoral components represent modifications to porous PS and CR Optetrak Logic femoral components cleared per 510(k) submission K123687 and can be used in either press-fit or cemented applications.

One Logic femoral components operate using the same fundamental scientific technology, have the same intended use and Indications for Use statements, are offered in the same product size scopes, have the same device compatibility, and are implanted using the same instrumentation and surgical techniques as cited corresponding predicate Optetrak Logic femoral components.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called "Optetrak One Logic Femoral Components." It's an FDA submission, and as such, it does not contain the kind of detailed study data, acceptance criteria, or ground truth information typical for an AI/ML device performance evaluation as outlined in your request.

The information provided pertains to a traditional medical device (knee replacement components), not an AI-powered diagnostic or predictive tool. Therefore, many of the requested categories are not applicable.

Here's why many of your specific questions cannot be answered from this document:

AI/ML Device: The device described is a physical knee implant, not an AI/ML software or system. Therefore, concepts like "test set," "training set," "experts to establish ground truth," "adjudication method," "MRMC comparative effectiveness," "standalone performance," and "effect size of human readers with/without AI assistance" are not relevant.
Acceptance Criteria for Performance: For a mechanical device like this, acceptance criteria typically relate to material properties, mechanical strength, wear resistance, and biocompatibility, rather than diagnostic accuracy metrics (e.g., sensitivity, specificity). The document mentions "mechanical patellofemoral constraint testing," but it doesn't specify the acceptance criteria for this test or the detailed results against those criteria. It only states that the testing was performed and supports substantial equivalence.
Study Details: The document refers to "engineering studies" and "testing", but it does not provide detailed study protocols, results, or statistical analyses that would allow for a breakdown of sample sizes, data provenance, ground truth establishment, or performance metrics in the way you've requested for an AI/ML device.

However, I can extract the following limited information that is somewhat related to your request, keeping in mind the context of a physical medical device:

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

This document does not provide a table of acceptance criteria and reported device performance in the manner you've requested for an AI/ML device (e.g., sensitivity, specificity, accuracy against a threshold). For a physical implant, acceptance criteria would typically involve engineering specifications (e.g., material strength, wear rates, fatigue life).

The document states: "This submission includes results for mechanical patellofemoral constraint testing." and "Results of engineering studies referenced in this 510(k) submission demonstrate proposed One Logic devices are substantially equivalent to cited cleared predicate Optetrak Logic devices." This indicates that the device met its performance criteria by demonstrating substantial equivalence to predicates through these engineering tests, but the specific numerical acceptance criteria and performance metrics are not detailed in this summary.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable in the context of an AI/ML test set. For mechanical testing of a physical device, sample sizes would refer to the number of components tested for strength, wear, etc. This information is not detailed in this summary.
Data Provenance: Not applicable in the context of an AI/ML test set. The "data" here would be mechanical test results from laboratory settings, typically performed by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. "Ground truth" in this context would be defined by engineering specifications and material science standards for the physical implant, not by expert consensus on diagnostic images or data.

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

Not applicable. Adjudication methods are used for resolving disagreements among human reviewers of diagnostic data, which is not relevant for mechanical testing of an implant.

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 is an AI/ML specific study type, not relevant for a physical knee implant.

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

Not applicable. This is an AI/ML specific performance metric, not relevant for a physical knee implant.

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

Not applicable in the AI/ML sense. For this device, the "truth" is established by adherence to engineering design specifications, material standards, and performance in standardized mechanical tests, as well as clinical experience with predicate devices.

8. The sample size for the training set:

Not applicable. This is an AI/ML specific concept.

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

Not applicable. This is an AI/ML specific concept.

In summary, this document is an FDA 510(k) clearance letter for a conventional medical device (knee implant components) and does not contain the detailed performance study information, acceptance criteria, or ground truth methodologies that would be relevant for an AI/ML-powered device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing to the right, arranged in a way that they appear to be interconnected. The profiles are rendered in a simple, line-art style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the graphic.

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

March 10, 2016

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

Re: K153776 Trade/Device Name: Optetrak One Logic Femoral Components Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: MBH, JWH Dated: February 11, 2016 Received: February 12, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K153776

Device Name

Optetrak One Logic Femoral Components

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K153776 - Page 1 of 3 Exactech® One Logic Femoral Components 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 Hughes Senior Regulatory Affairs Specialist
Date: February 11, 2016

Trade or Proprietary or Model Name(s):

Exactech® Optetrak® One Logic Femoral Components

Common Name: Cemented Total Knee Prosthesis

Classification Name:

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Product Code: MBH, JWH

Classification Panel: Orthopedic

Regulation Number 888.3565, 888.3560

Device Class II

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or Proprietary Model Name	Manufacturer
K093360	Optetrak Logic PS
K111400	Optetrak Logic CR, Sizes 1-5	Exactech, Inc
K121307	Optetrak Logic CR, Sizes 0 & 6
K123687	Optetrak Logic Porous Femoral Components

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K153776 - Page 2 of 3 Exactech® One Logic Femoral Components Special 510(k) - 510(k) Summary of Safety and Effectiveness

Indications for Use:

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:

Technological Characteristics

One Logic femoral components are made from CoCr alloy. Like other femoral implants in the Optetrak / Optetrak Logic device family. One Logic femoral components are designed to articulate on an ultra-high molecular weight polyethylene tibial insert seated in a metal tibial tray.

One Logic CR and PS femoral components have the same basic features, boneapposing dimensions, articulating surface finish, and surface coating (where applicable) as predicate Optetrak Logic femoral components while providing surgeons with an option for comparatively streamlined and "softened" geometry, created by including slightly increased radii on the anterior aspect of the subject devices. The articulating congruence featured in all Optetrak and Optetrak Logic femoral-tibial condyle contact is maintained for One Logic femoral components. One

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K153776 - Page 3 of 3 Exactech® One Logic Femoral Components Special 510(k) - 510(k) Summary of Safety and Effectiveness

Logic CR femoral components also feature a modified patella entry / exit point at the distal trochlear groove, intended to enhance patella transition.

Testing Description:

This submission includes results for mechanical patellofemoral constraint testing.

Substantial Equivalence Conclusion:

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

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.